About this trial
So far, MRD assessment by liquid biopsy (ctDNA) has not been used to predict postoperative treatment efficacy and recurrence risk of GIST patients because of special disease characteristics and technological limitations. Therefore, we conducted this prospective multi-center, single-arm observational study to collect 45 operable patients with locally advanced, suspected high-risk GIST. NGS genetic testing platform is used to detect tumour tissues and peripheral ctDNA will also be dectected. we try to explore the correlation between PFS/OS and MRD in high-risk GIST patients by analyzing the relationship between dynamic changes in ctDNA mutation spectrum and postoperative adjuvant therapy efficacy, and to evaluate MRD-based genomic characteristics to guide further treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged between 18 and 80
Patients suspected for high-risk GIST by preoperative imaging examinations or diagnosed with high-risk GIST by pathological biopsy, who have not received preoperative neoadjuvant treatment
Patients must have not received any treatment including radiotherapy, chemotherapy or surgery
The function of other organs including liver and kidneys is good enough so that the patients could tolerate targeted therapy and surgery
Disqualifiers
Previous medical history of malignant tumors or synchronous other malignancies
Emergent surgery because of bowel obstruction, perforation or bleeding
Pregnant or lactant women
Medical history of severe mental illness
Trial population
This study plans to invite patients with the following criteria: patients with resectable locally advanced GIST who received or did not receive neoadjuvant molecular targeted therapy, and patients with high recurrence risk grading by postoperative pathological assessment, including but not limited to the following clinical factors: Tumor Location, size, degree of mitoses, degree of tumor rupture, etc. Those who did not reach R0 resection or did not match the pathological staging, or who could not complete the test items required by the trial within the specified time due to the patient's non-cooperation, or who were deemed unsuitable by other investigators, would not be invited to participate in this study.
Trial design
Case-only
Prospective
Treatments tested in this trial
liquid biopsy
Diagnostic testA test that enables the diagnosis or analysis of tumors using only a blood or fluid sample rather than a solid tissue biopsy.
Treatment groups
Trial outcomes
Primary outcomes
recurrence
Recurrence or metastasis of high-risk GIST after surgical resection followed by targeted drug therapy
Sponsors and contacts
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