Status:

RECRUITING

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

Lead Sponsor:

Peking University People's Hospital

Conditions:

Gastrointestinal Stromal Tumors

Minimal Residual Disease

Eligibility:

All Genders

Brief 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 techno...

Detailed Description

Assessing MRD (Minimal Residual Disease) and predicting the postoperative adjuvant treatment efficacy and recurrence risk of tumor patients based on ctDNA (circulating tumor DNA) detected by liquid bi...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

April 1 2028

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT05408897

Start Date

January 1 2022

End Date

April 1 2028

Last Update

September 21 2022

Active Locations (1)

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Peking University People'S Hospital

Beijing, Beijing Municipality, China, 100044