Predicting treatment outcomes and recurrence risk in high-risk GIST patients using liquid biopsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the efficacy of postoperative treatments and the risk of recurrence in patients with high-risk gastrointestinal stromal tumors (GIST) by utilizing liquid biopsy to analyze circulating tumor DNA (ctDNA). A total of 45 operable patients suspected of having high-risk GIST will be enrolled, and their tumor tissues and ctDNA will be analyzed using Next-Generation Sequencing (NGS) to explore the correlation between ctDNA mutation changes and treatment outcomes. The study seeks to provide insights into how MRD (Minimal Residual Disease) can guide further treatment decisions based on genomic characteristics.

Why it matters

Who can join: the full rules

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

Where it's running

• Peking University People'S Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Yingjiang Ye — Peking University People's Hospital

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.