Predicting treatment outcomes and recurrence risk in high-risk GIST patients using liquid biopsy
Prediction of Postoperative Treatment Efficacy and Recurrence Risk of High-risk GIST Based on Minimal Residual Disease Detected by Liquid Biopsy
This study is trying to see if analyzing blood samples for tumor DNA can help doctors predict treatment success and the chance of cancer coming back in patients with high-risk gastrointestinal stromal tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05408897 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 who have been diagnosed with high-risk GIST and have not received any prior treatment.
Not a fit: Patients with previous malignancies, severe mental illness, or those requiring emergency surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized treatment strategies and improved outcomes for patients with high-risk GIST.
How similar studies have performed: While liquid biopsy has been explored in various cancers, its application in predicting outcomes for high-risk GIST is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- Peking University People'S Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Yingjiang Ye — Peking University People's Hospital
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.