Prediction of Postoperative Treatment Efficacy and Recurrence Risk of High-risk GIST Based on Liquid Biopsy MRD

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking University People's Hospital

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • liquid biopsy

    Diagnostic test

    A test that enables the diagnosis or analysis of tumors using only a blood or fluid sample rather than a solid tissue biopsy.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

recurrence

Recurrence or metastasis of high-risk GIST after surgical resection followed by targeted drug therapy

Time frame
3 to 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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