[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Minimally Invasive Surgery Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":156},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,69,88,109,133],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100650437","prospective-assessment-of-alignment-between-multimodal-artificial-intelligence-and-multidisciplinary-team-decisions-in-gastrointestinal-oncology-100650437",false,"NCT07746830","Prospective Assessment of Alignment Between Multimodal Artificial Intelligence and Multidisciplinary Team Decisions in Gastrointestinal Oncology","Inclusion Criteria:\n\n1. Aged 18 years or older, with no restriction based on sex.\n2. Histologically confirmed gastric, colon, or rectal cancer; or highly suspected gastric, colon, or rectal malignancy based on clinical, endoscopic, or imaging findings, with further diagnostic, staging, or treatment planning required.\n3. Scheduled for multidisciplinary team evaluation at the study center because of an initial diagnosis, clinical staging, perioperative treatment, surgical planning, recurrence or metastasis, conversion therapy, treatment response assessment, or another complex clinical management question.\n4. A clearly identifiable clinical decision time point can be established, and the clinical information available before that time point can be defined.\n5. At the clinical decision time point, at least the basic medical history, the clinical question to be addressed, and at least one core source of information from endoscopy, pathology, or imaging are available. Completion of all examinations is not required, because missing examinations may be evaluated as part of diagnostic task planning.\n6. A corresponding multidisciplinary team recommendation regarding diagnostic tasks or the principal treatment decision can be obtained for comparison with the artificial intelligence output.\n7. Willing and able to understand the study and provide dated written informed consent.\n\nExclusion Criteria:\n\n1. Further examination confirms a condition other than gastric, colon, or rectal cancer, and the case is not applicable to the gastrointestinal oncology pathways evaluated in this study.\n2. The participant is undergoing routine follow-up or continuation of a previously established treatment plan and has no clinical question requiring additional diagnostic tasks, modification of the principal treatment pathway, or multidisciplinary team decision-making.\n3. A clear clinical decision time point cannot be established, or information available before and after the decision cannot be distinguished, preventing comparison of the artificial intelligence system and the multidisciplinary team under the same information conditions.\n4. Core clinical information is severely incomplete, such that the current stage of care and the clinical question cannot be identified and a clinically meaningful artificial intelligence output cannot be generated.\n5. A clear multidisciplinary team recommendation corresponding to the clinical decision time point cannot be obtained, or the multidisciplinary team documentation is insufficient for paired evaluation.\n6. The participant requires immediate resuscitation or urgent clinical management, and study recruitment could interfere with necessary medical care.\n7. The participant is unable to provide valid informed consent because of impaired consciousness, severe cognitive impairment, or another reason, and no ethics-approved proxy consent procedure is available for this study.\n8. The participant declines research use of the medical record, endoscopic, pathological, imaging, or other required clinical data.\n9. Any other condition that, in the investigator's judgment, could seriously affect participant rights, data compliance, or the reliability of the study results.","ALL","18 Years",{"count":18,"type":19},69,"ESTIMATED","3 Years","OBSERVATIONAL","This prospective, single-center observational study will evaluate the concordance between a multimodal artificial intelligence system and multidisciplinary team decisions in patients with gastrointestinal tumors. For each enrolled case, the AI system and the MDT will independently review the same available clinical information, including medical history, laboratory findings, imaging, pathology, and other relevant diagnostic data, and will generate recommendations regarding diagnosis, staging, treatment planning, and further examinations. An independent expert panel will assess the agreement, clinical appropriateness, and potential major errors of the two decision pathways. AI-generated recommendations will be used solely for research evaluation and will not directly influence patient care. The study aims to determine the feasibility, reliability, and safety of multimodal AI-assisted decision-making in real-world gastrointestinal oncology workflows.",[24,25,26],"Gastric Cancer","Colorectal Cancer","Gastrointestinal Cancer",[25,24,28,29],"MDT","Artificial Intelligence","NOT_YET_RECRUITING","2026-07-31",{"date":33,"type":34},"2026-08-05","ACTUAL",{"date":33,"type":19},{"date":37,"type":19},"2028-08-05",{"name":39,"class":40},"Shanghai Minimally Invasive Surgery Center","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":50,"targetDuration":52,"studyType":21,"phases":4,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":41},"100598860","development-and-validation-of-metabolic-biomarkers-for-early-diagnosis-prognosis-and-recurrence-of-gastric-cancermetbio-gc-100598860","NCT07076979","Development and Validation of Metabolic Biomarkers for Early Diagnosis, Prognosis, and Recurrence of Gastric Cancer：MetBio-GC","Development and Validation of Metabolic Biomarkers for Early Diagnosis, Prognosis, and Recurrence of Gastric：MetBio-GC","Inclusion Criteria:\n\n* \\*\\*Healthy Controls:\\*\\*\n\n  1. Age \\> 18 years;\n  2. Signed informed consent and willingness to participate in the project.\n\n\\*\\*Gastric Cancer:\\*\\*\n\n1. Age ≥ 18 years;\n2. Performance status (ECOG) score ≤ 1;\n3. Histopathologically confirmed gastric adenocarcinoma;\n4. No family history of hereditary cancer;\n5. No prior anti-tumor treatment;\n6. Availability of primary tumor tissue from surgery or biopsy that meets submission requirements;\n7. Availability of peripheral blood samples that meet submission requirements;\n8. Willingness and ability to sign the informed consent form to participate in the study.\n\nExclusion Criteria:\n\n* \\*\\*Healthy Controls:\\*\\*\n\n  1. Individuals at high risk for hereditary colorectal adenocarcinoma, including family members of the following diseases: family history of gastrointestinal tumors, familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC\u002FLS), and Peutz-Jeghers syndrome (P-J syndrome);\n  2. History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease;\n  3. Known history of other malignancies that have progressed or required treatment within the past 5 years, except for skin basal cell carcinoma and squamous cell carcinoma that have been cured;\n  4. History of oral or intravenous use of broad-spectrum antibiotics and probiotics within the past month;\n  5. Regular use of immunosuppressive drugs within the past 6 months;\n  6. Long-term use of other medications that may affect metabolism, such as hormones;\n  7. Inability or unwillingness to cooperate with follow-up visits and related examinations;\n  8. Inability to eat normally or requiring medications or enemas for bowel movements;\n  9. Presence of psychiatric disorders or other severe cardiovascular diseases;\n  10. Pregnant, breastfeeding, or planning to become pregnant within the next year;\n  11. Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision.\n\n\\*\\*Gastric Cancer:\\*\\*\n\n1. Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision;\n2. Known history of other malignancies that have progressed or required treatment within the past 5 years, except for skin basal cell carcinoma and squamous cell carcinoma that have been cured;\n3. History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease;\n4. Presence of poorly controlled chronic comorbidities that may affect prognosis;\n5. Presence of psychiatric disorders or other severe cardiovascular diseases;\n6. Pregnant, breastfeeding, or planning to become pregnant within the next year;\n7. Long-term use of medications that may affect metabolism, such as hormones, immunosuppressants, antibiotics, etc.;\n8. Any severe and\u002For uncontrolled medical conditions, as judged by the investigator, that may affect the patient's ability to participate in the study or interfere with study results.",true,{"count":51,"type":19},250,"5 Years","This prospective clinical observational study aims to construct a metabolite database specifically for gastric cancer patients using metabolomics technology. It seeks to develop and validate metabolic biomarkers for early diagnosis, prognosis, and prediction of recurrence and metastasis in gastric cancer, thereby a establishing safe, convenient, and highly sensitive method for early screening and prognostic prediction.",[24],[56,57,58,59],"Gastric cancer","Metabolic marker","Prognosis","Early diagnosis","RECRUITING","2025-07-19",{"date":63,"type":34},"2025-07-22",{"date":65,"type":34},"2025-06-15",{"date":67,"type":19},"2030-07-01",{"name":39,"class":40},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":49,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":76,"targetDuration":52,"studyType":21,"phases":4,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":86,"leadSponsor":87,"locationsCount":41},"100598210","development-and-validation-of-metabolic-biomarkers-for-early-diagnosis-prognosis-and-recurrence-of-colorectal-cancermetbio-crc-100598210","NCT07068529","Development and Validation of Metabolic Biomarkers for Early Diagnosis, Prognosis, and Recurrence of Colorectal Cancer：MetBio-CRC","Development and Validation of Metabolic Biomarkers for Early Diagnosis, Prognosis, and Recurrence of Gastric Cancer：MetBio-CRC","Inclusion Criteria:\n\n* \\*\\*Healthy Controls:\\*\\*\n\n  1. Age ≥ 18 years;\n  2. Signed informed consent and willingness to participate in the project.\n\n\\*\\*Colorectal Cancer:\\*\\*\n\n1. Age ≥ 18 years;\n2. Performance status (ECOG) score ≤ 1;\n3. Histopathologically confirmed colorectal adenocarcinoma;\n4. No family history of hereditary cancer;\n5. No prior anti-tumor treatment;\n6. Availability of primary tumor tissue from surgery or biopsy that meets submission requirements;\n7. Availability of peripheral blood samples that meet submission requirements;\n8. Willingness and ability to sign the informed consent form to participate in the study.\n\nExclusion Criteria:\n\n* \\*\\*Healthy Controls:\\*\\*\n\n  1. Individuals at high risk for hereditary colorectal adenocarcinoma, including family members of the following diseases: family history of gastrointestinal tumors, familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC\u002FLS), and Peutz-Jeghers syndrome (P-J syndrome);\n  2. History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease;\n  3. Known history of other malignancies that have progressed or required treatment within the past 5 years, except for skin basal cell carcinoma and squamous cell carcinoma that have been cured;\n  4. History of oral or intravenous use of broad-spectrum antibiotics and probiotics within the past month;\n  5. Regular use of immunosuppressive drugs within the past 6 months;\n  6. Long-term use of other medications that may affect metabolism, such as hormones;\n  7. Inability or unwillingness to cooperate with follow-up visits and related examinations;\n  8. Inability to eat normally or requiring medications or enemas for bowel movements;\n  9. Presence of psychiatric disorders or other severe cardiovascular diseases;\n  10. Pregnant, breastfeeding, or planning to become pregnant within the next year;\n  11. Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision.\n\n\\*\\*Colorectal Cancer:\\*\\*\n\n1. A clear family history of hereditary colorectal cancer, such as Lynch syndrome, familial adenomatous polyposis, Peutz-Jeghers syndrome, etc.;\n2. Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision;\n3. Known history of other malignancies that have progressed or required treatment within the past 5 years, except for skin basal cell carcinoma and squamous cell carcinoma that have been cured;\n4. History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease;\n5. Presence of poorly controlled chronic comorbidities that may affect prognosis;\n6. Presence of psychiatric disorders or other severe cardiovascular diseases;\n7. Pregnant, breastfeeding, or planning to become pregnant within the next year;\n8. Long-term use of medications that may affect metabolism, such as hormones, immunosuppressants, antibiotics, etc.;\n9. Any severe and\u002For uncontrolled medical conditions, as judged by the investigator, that may affect the patient's ability to participate in the study or interfere with study results.",{"count":51,"type":19},"This prospective clinical observational study aims to construct a metabolite database specifically for colorectal cancer patients using metabolomics technology. It seeks to develop and validate metabolic biomarkers for early diagnosis, prognosis, and prediction of recurrence and metastasis in colorectal cancer, thereby a establishing safe, convenient, and highly sensitive method for early screening and prognostic prediction.",[25],[25,80,58,81],"Metabolic Marker","Early Diagnosis","2025-07-07",{"date":84,"type":34},"2025-07-16",{"date":65,"type":34},{"date":67,"type":19},{"name":39,"class":40},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":94,"targetDuration":96,"studyType":21,"phases":4,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100573439","a-prospective-study-of-expression-profiling-based-assessment-of-the-efficacy-of-neoadjuvant-therapy-for-rectal-cancer-100573439","NCT06746298","A Prospective Study of Expression Profiling-based Assessment of the Efficacy of Neoadjuvant Therapy for Rectal Cancer","Inclusion Criteria:\n\n* Age ≥18 years, male or infertile female\n* Patients with rectal adenocarcinoma diagnosed by colonoscopic biopsy\n* Neoadjuvant therapy according to guideline recommendations\n* Endoscopic biopsy with access to biopsy tissue for subsequent RNA-seq testing\n* Patients who do not have a combination of primary malignant tumors elsewhere.\n* Patients who understand the purpose of the trial, participate voluntarily and sign an informed consent form.\n\nExclusion Criteria:\n\n* Samples are not collected, stored, or processed in accordance with specified requirements\n* Sample does not meet the requirements for subsequent RNA-seq testing\n* Cases enrolled with a subsequent diagnosis other than rectal adenocarcinoma.\n* The patient refuses or is unable to complete the entire neoadjuvant treatment\n* Lack of post-neoadjuvant imaging results and lack of routine postoperative pathology results.\n* Other patients who, in the judgment of the investigator, do not meet the enrollment requirements",{"count":95,"type":19},118,"60 Months","This is a prospective study of expression profiling-based assessment of the efficacy of neoadjuvant therapy for rectal cancer.",[99,100],"Rectal Cancer","Neoadjuvant Therapy","2024-12-19",{"date":103,"type":34},"2024-12-24",{"date":105,"type":19},"2025-01-01",{"date":107,"type":19},"2027-05-31",{"name":39,"class":40},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":41},"100518915","phase-2-exploratory-single-arm-single-center-adjuvant-treatment-of-stage-iiib-iiic-gastric-cancer-with-combination-of-palizumab-and-sox-regimen-100518915","NCT06036745","Exploratory Single-arm, Single-center Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer With Combination of Palizumab and SOX Regimen","An Exploratory Single-Arm, Single-Center Study of Pembrolizumab in Combination With SOX Regimen for Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer","Inclusion Criteria:\n\n* 1\\. Subjects voluntarily join the study and sign an informed consent form; 2. Male or female patients between the ages of 18-75; 3. Adenocarcinoma of the gastric\u002Fesophagogastric junction after radical resection was staged at stage IIIB-IIIC; 4. The molecular pathology of gastric cancer must meet at least one of the following three conditions:\n\n  1. Consistent with high-frequency microsatellite instability MSI-H\n  2. Consistent with high tumor mutation load TMB-H (≥10 mutations\u002Fmegabases)\n  3. High expression of PD-L1 (CPS score ≥5) 5. Expected survival time \\> 6 months； 6. ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points; 7. Have not received anti-tumor immunotherapy; 8. Agree to provide archived tumor tissue samples for molecular testing; 9. Have good organ function:\n\n  \u003C!-- -->\n\n  1. Hemoglobin ≥90g\u002FL;\n  2. Absolute neutrophil count ≥1.5×109\u002F L;\n  3. Platelet count ≥100×109\u002F L;\n  4. aspartate or alanine aminotransferase ≤ 2.5 times the upper limit;\n  5. alkaline phosphatase ≤ 2.5 times the upper normal limit ; 10. Women of reproductive age who need to use a medically approved contraceptive method (such as an IUD, contraceptive pill, or condom) during the study treatment period and for 3 months after the end of the study treatment period; For men who agreed to use an appropriate method of contraception during the trial and for 3 months after the last dose of the trial drug.\n\n     11\\. Women of reproductive age must be negative for serum or urine HCG within 72 hours prior to study entry. And must be non-lactating.\n\n     Exclusion Criteria:\n\n  \u003C!-- -->\n\n  1. Patients with severe hypertension and poor drug control;\n  2. Patients with difficulty in taking oral drugs due to dysphagia, complete or incomplete digestive tract obstruction, active gastrointestinal bleeding, perforation, etc.;\n  3. People who are known to be allergic to the ingredients in the test drug or have metabolic disorders;\n  4. Simultaneously participating in other tumor experimental drugs or being in other tumor clinical trials.\n  5. Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrollable diabetes, hypertension and other chronic system diseases; Clinically obvious heart disease, such as congestive heart failure, obvious coronary heart disease, medically difficult to control arrhythmia, hypertension, or myocardial infarction within 6 months, or cardiac insufficiency;\n  6. Patients with peripheral nervous system disorders or a history of obvious mental disorders and central nervous system disorders;\n  7. Diagnosed with immunodeficiency or received systemic hormone therapy or other forms of immunosuppressive therapy within 7 days prior to initial administration;\n  8. Active period \\> CTCAE (Version 5.0) grade 2 clinical severe infection;\n  9. Pregnant and lactating women, women of childbearing age and their spouses refuse to take effective contraceptive methods;\n  10. Persons without legal capacity, whose medical or ethical reasons affect the continuation of the research.\n  11. Other conditions determined by the investigator to be unsuitable for inclusion in the study.","75 Years",{"count":118,"type":19},20,"INTERVENTIONAL",[121],"PHASE2","it is an an Exploratory Single-Arm, Single-Center Study of Pembrolizumab in Combination with SOX Regimen for Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer",[124],"Gastric Cancer Stage IIIB-IIIC","2024-03-05",{"date":127,"type":34},"2024-03-07",{"date":129,"type":34},"2022-07-01",{"date":131,"type":19},"2026-07-01",{"name":39,"class":40},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":140,"minAge":16,"maxAge":116,"enrollmentInfo":141,"targetDuration":4,"studyType":119,"phases":143,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":41},"100477290","transvaginal-noses-versus-conventional-laparoscopic-surgery-for-right-hemicolectomy-100477290","NCT05495048","Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy","Transvaginal Natural Orifice Specimen Extraction Surgery Versus Conventional Laparoscopic Surgery With Mini-laparotomy in Right Hemicolectomy for Colon Cancer: a Randomised, Controlled, Phase 3, Non-inferiority Trial (NOSES VIIIA Trial)","Inclusion Criteria:\n\n* volunteer to participate and the informed consent signed;\n* 18-75 years;\n* female who have given birth;\n* pathologically confirmed adenocarcinoma\u002Fhigh-grade intraepithelial neoplasia by preoperative colonoscopy and biopsy;\n* preoperative CT or MRI indicates that the tumor diameter is no more than 5.0 cm;\n* preoperative staging cT1-3NanyM0\n* body mass index \\\u003C30 kg\u002Fm2;\n* willing to undergo laparoscopic right hemicolectomy\n\nExclusion Criteria:\n\n* contraindications for laparoscopic surgery;\n* emergency surgery due to acute intestinal obstruction, perforation or bleeding;\n* distant metastasis;\n* multiple colorectal cancer;\n* has received preoperative chemoradiotherapy;\n* with a history of other malignant tumors;\n* unwilling to sign the informed consent or receive follow-up according to the study protocol.","FEMALE",{"count":142,"type":19},356,[144],"NA","It is controversial that totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction (NOSES VIIIA) can provide non-inferior oncological outcomes compared to conventional laparoscopic surgery with mini-laparotomy in the treatment of right colon cancer. We aim to carry out a multicenter, open-lable, parallel, non-inferiority, phase III, randomized controlled clinical trial, which enrolls 356 female patients with cT1-3NxM0 right colon adenocarcinoma. They are randomly assigned to the experimental group (NOSES VIIIA) or the control group (laparoscopic surgery with mini-laparotomy) in a 1:1 ratio. Perioperative indicators, pathological results, quality of life and cosmetic evaluation will be compared between the two groups. Then, a three-year follow-up of these patients will provide evidence for long-term oncological outcomes of NOSES VIIIA.",[147],"Colon Cancer","2024-02-22",{"date":150,"type":34},"2024-02-26",{"date":152,"type":34},"2023-07-01",{"date":154,"type":19},"2028-12-31",{"name":39,"class":40},""]