Blood test may spot hidden GIST recurrence before scans do

NCT ID NCT05867901

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This study is looking at whether a blood test that detects tiny traces of tumor DNA (called minimal residual disease, or MRD) can predict if a high-risk gastrointestinal stromal tumor (GIST) will return after surgery. The study will follow 66 patients who have had their tumor removed and are not currently on adjuvant therapy. Participants will give blood samples and have regular CT scans for three years. The goal is to see if the blood test can spot recurrence earlier than standard imaging, and whether combining the test with other factors can improve recurrence prediction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tumor-informed ctDNA-based MRD testing (a blood test that looks for tiny traces of tumor DNA)
What this could lead to
If successful, this blood test could help doctors predict and detect GIST recurrence earlier than standard imaging, potentially guiding more timely treatment decisions.
What could go wrong
This is a small, observational study, and the test results are not yet proven to be reliable enough to change treatment. The test may not detect all recurrences or could give false alarms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients aged 18 to 75 years with pathologically confirmed high-risk gastrointestinal stromal tumor who have undergone R0 resection of the primary tumor and meet the protocol-defined eligibility criteria for postoperative MRD surveillance.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: I. Inclusion Criteria for the Prospective Study on Postoperative Minimal Residual Disease (MRD) Surveillance in High-Risk Gastrointestinal Stromal Tumors (GIST) Without Adjuvant Therapy 1. Aged 18-75 years. 2. Patients suspected of having high-risk GIST based on preoperative imaging, or patients with biopsy-confirmed high-risk GIST who have not received preoperative neoadjuvant therapy. 3. Treatment-naive patients who have not previously received radiotherapy, chemotherapy, surgery, or any other anticancer treatment. 4. Adequate hepatic, renal, and other major organ function, with the patient considered medically fit to undergo surgery. 5. Postoperative pathological confirmation of gastrointestinal stromal tumor. 6. Tumor genotyping demonstrating a genotype associated with primary resistance to imatinib, such as a PDGFRA D842V mutation, or a clear decision by the patient to decline postoperative adjuvant imatinib therapy. 7. A definite contraindication to imatinib or another targeted therapy. 8. Patients who underwent R0 resection of the primary tumor, completed long-term postoperative adjuvant therapy, and discontinued treatment at least 3 months previously. 9. The patient and family members are able to understand the study protocol; the patient voluntarily agrees to participate and provides written informed consent. II. Inclusion Criteria for the Development of a Genomics-Based Recurrence Risk Prediction Model for High-Risk GIST and Identification of the Optimal Target Population for MRD Surveillance a. The inclusion criteria are identical to those of the prospective study on postoperative MRD surveillance in high-risk GIST without adjuvant therapy. Exclusion Criteria: I. Exclusion Criteria for the Prospective Study on Postoperative Minimal Residual Disease (MRD) Surveillance in High-Risk Gastrointestinal Stromal Tumors (GIST) Without Adjuvant Therapy 1. A history of another malignant tumor or the presence of another concurrent malignancy. 2. Emergency surgery required because of intestinal obstruction, perforation, bleeding, or a similar condition. 3. Pregnancy or breastfeeding. 4. A history of severe psychiatric illness. 5. Any contraindication to surgical treatment. 6. Failure to achieve R0 resection. 7. Low- or intermediate-risk disease according to postoperative pathological risk stratification. 8. Presence of distant metastasis. 9. Any other condition that, in the investigator's judgment, renders the patient unsuitable for enrollment. II. Exclusion Criteria for the Development of a Genomics-Based Recurrence Risk Prediction Model for High-Risk GIST and Identification of the Optimal Target Population for MRD Surveillance a. The exclusion criteria are identical to those of the prospective study on postoperative MRD surveillance in high-risk GIST without adjuvant therapy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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Contacts and locations

Locations

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044, China

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