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Recruiting Observational

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

NCT05408897 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2022-01-01
Last updated
2022-09-21

Condition(s) studied

Gastrointestinal Stromal TumorsMinimal Residual Disease

Investigational drug(s) / intervention(s)

liquid biopsy

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

Study summary

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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • recurrence — 3 to 5 years
    Recurrence or metastasis of high-risk GIST after surgical resection followed by targeted drug therapy

Trial sites (1)

FacilityCityRegionStatus
Peking University People'S Hospital Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05408897 on ClinicalTrials.gov ↗ ← All trials in China