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

Recruitingn/aAges any - anyAllPeking University People's Hospital
NCT05408897 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Postoperative pathology conformed the diagnosis of high-risk GIST * Patients and their families could understand the protocol of this study and voluntarily agree to participate in. Signed informed consents are required Exclusion Criteria: * 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 * Patients with contraindication for targeted therapy and surgery * Non-R0 resection * Postoperative pathology conformed the diagnosis of non-high-risk GIST * Patients with distant metastasis * Other situations in which researchers consider that the patient is unsuitable for this study
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What it tests

  • liquid biopsy
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Where

1 site
Peking University People'S Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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