NCT05408897Recruiting
Prediction of Postoperative Treatment Efficacy and Recurrence Risk of High-risk GIST Based on Liquid Biopsy MRD
Prediction of Postoperative Treatment Efficacy and Recurrence Risk of High-risk GIST Based on Minimal Residual Disease Detected by Liquid Biopsy
Source: ClinicalTrials.gov · Last updated 21 Sept 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 45 (estimated)
- First submitted
- 2 Jun 2022
- Start date
- 1 Jan 2022
- Primary completion date
- Apr 2023
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Childhood cancers
- NCT number
- NCT05408897
What you commit to
- Study type: Observational
- Planned participants: 45
- From 1 Jan 2022 to the primary completion date, Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with contraindication for targeted therapy and surgery
- Non-R0 resection
Other illness
- Previous medical history of malignant tumors or synchronous other malignancies
- Emergent surgery because of bowel obstruction, perforation or bleeding
- Medical history of severe mental illness
Other
- Pregnant or lactant women
- 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
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.