Actively Recruiting

All Genders
NCT05408897

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

Led by Peking University People's Hospital · Updated on 2022-09-21

45

Participants Needed

1

Research Sites

326 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 18 and 80
  • Patients suspected for high-risk GIST by preoperative imaging or diagnosed by pathological biopsy, who have not received preoperative neoadjuvant treatment
  • Patients must not have received any treatment including radiotherapy, chemotherapy, or surgery
  • Good liver and kidney function to tolerate targeted therapy and surgery
  • Postoperative pathology confirming high-risk GIST diagnosis
  • Patients and their families understand the study protocol and voluntarily agree to participate with signed informed consent
Not Eligible

You will not qualify if you...

  • Previous history of malignant tumors or other simultaneous malignancies
  • Emergency surgery due to bowel obstruction, perforation, or bleeding
  • Pregnant or lactating women
  • History of severe mental illness
  • Contraindications for targeted therapy and surgery
  • Non-R0 (non-complete) tumor resection
  • Postoperative pathology showing non-high-risk GIST
  • Presence of distant metastasis
  • Other conditions judged by researchers as unsuitable for the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University People'S Hospital

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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