Gastrointestinal Stromal TumorsNCT05867901
A Prospective Study on Predicting Recurrence Risk of Postoperative High-risk GISTs in NED State Based on MRD Detection Via Liquid Biopsy
An observational study of Gastrointestinal Stromal Tumors, run by Peking University People's Hospital at 1 site in China.
Trial summary
The goal of this single-center, prospective, observational cohort study is to learn whether tumor-informed minimal residual disease (MRD) testing in blood can predict recurrence in 66 patients with high-risk gastrointestinal stromal tumor (GIST) who are not currently receiving postoperative adjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- Tumor-Informed ctDNA-Based MRD Testing and Contrast-Enhanced CT
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Inclusion Criteria for the Prospective Study on Postoperative Minimal Residual Disease (MRD) Surveillance in High-Risk Gastrointestinal Stromal Tumors (GIST) Without Adjuvant Therapy
- Aged 18-75 years.
- 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.
- Treatment-naive patients who have not previously received radiotherapy, chemotherapy, surgery, or any other anticancer treatment.
- Adequate hepatic, renal, and other major organ function, with the patient considered medically fit to undergo surgery.
- Postoperative pathological confirmation of gastrointestinal stromal tumor.
Show all 11Show fewer
- 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.
- A definite contraindication to imatinib or another targeted therapy.
- Patients who underwent R0 resection of the primary tumor, completed long-term postoperative adjuvant therapy, and discontinued treatment at least 3 months previously.
- The patient and family members are able to understand the study protocol; the patient voluntarily agrees to participate and provides written informed consent.
- 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.
Who cannot join
- Exclusion Criteria for the Prospective Study on Postoperative Minimal Residual Disease (MRD) Surveillance in High-Risk Gastrointestinal Stromal Tumors (GIST) Without Adjuvant Therapy
- A history of another malignant tumor or the presence of another concurrent malignancy.
- Emergency surgery required because of intestinal obstruction, perforation, bleeding, or a similar condition.
- Pregnancy or breastfeeding.
- A history of severe psychiatric illness.
- Any contraindication to surgical treatment.
Show all 12Show fewer
- Failure to achieve R0 resection.
- Low- or intermediate-risk disease according to postoperative pathological risk stratification.
- Presence of distant metastasis.
- Any other condition that, in the investigator's judgment, renders the patient unsuitable for enrollment.
- 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
- The exclusion criteria are identical to those of the prospective study on postoperative MRD surveillance in high-risk GIST without adjuvant therapy.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Prospective Study on Predicting Recurrence Risk of Postoperative High-risk Gastrointestinal Stromal Tumors in NED State Based on Minimal Residual Disease Detection Via Liquid Biopsy
The goal of this single-center, prospective, observational cohort study is to learn whether tumor-informed minimal residual disease (MRD) testing in blood can predict recurrence in 66 patients with high-risk gastrointestinal stromal tumor (GIST) who are not currently receiving postoperative adjuvant therapy. The main questions it aims to answer are:
Can changes in MRD during follow-up predict tumor recurrence? How closely do MRD results agree with contrast-enhanced computed tomography (CT) findings, and can MRD identify recurrence earlier than CT? Can tumor genomic features, changes in MRD, and clinicopathological features be combined to develop a model for predicting recurrence risk? Participants will have their surgical tumor tissue analyzed, provide blood samples for MRD testing, and undergo regular clinical follow-up and contrast-enhanced CT examinations for 3 years. Participants may choose to receive and discuss their MRD results. This study will not assign or change treatment based on MRD results. Recurrence and treatment decisions will remain based on routine clinical assessment, primarily contrast-enhanced CT and multidisciplinary review.
Read the detailed description
This is a single-center, prospective, single-cohort, non-interventional observational study. The prospective cohort will include 66 patients with high-risk gastrointestinal stromal tumor (GIST) who have undergone R0 resection of the primary tumor. Eligible patients will either have no plan to receive postoperative adjuvant therapy or meet protocol-defined eligibility criteria after discontinuing such therapy.
Baseline tumor tissue will undergo whole-exome sequencing (WES) and next-generation sequencing (NGS). Fifty patient-specific variants associated with tumor development, progression, and individualized treatment will be selected to construct a personalized testing module. Cell-free DNA from peripheral blood will be analyzed using unique molecular identifier-based ultra-deep targeted NGS at a sequencing depth of approximately 100,000×. MRD positivity is defined as the detection of at least two significant loci with P ≤ 0.005.
Baseline contrast-enhanced computed tomography (CT) will confirm no evidence of disease before enrollment. Contrast-enhanced CT will be repeated every 3 months during 3 years of follow-up. Magnetic resonance imaging or positron emission tomography-CT may be performed when needed. Two experienced radiologists will independently review the CT images. Disagreements will be adjudicated by a third radiologist. Imaging recurrence will be evaluated according to Response Evaluation Criteria in Solid Tumors version 1.1 and confirmed by a multidisciplinary team.
Blood-based MRD testing will be performed at baseline and at protocol-specified follow-up visits. The study will compare MRD results with CT-based recurrence assessments and evaluate the predictive performance of MRD. It will also estimate the interval between the first MRD signal of recurrence and CT-confirmed recurrence.
The study will not assign or modify treatment. Participants who choose to receive their MRD results will receive a standardized explanation that the results are investigational. MRD results cannot independently establish a diagnosis of recurrence or guide treatment decisions. Participants who initiate a tyrosine kinase inhibitor (TKI) before imaging-confirmed recurrence may remain in follow-up. The primary MRD performance analysis will include only MRD, imaging, and clinical data collected before TKI initiation. Post-TKI recurrence status will not be used to reclassify pre-TKI MRD results in the primary MRD performance analysis.
After 3-year outcomes become available, data from the 66 prospective participants and 49 retrospective cases will be used to develop a recurrence-risk prediction model. The combined cohort will be randomly divided into training and internal test sets using an 8:2 stratified split. Candidate variables will first be screened using area under the receiver operating characteristic curve and missingness criteria. Least absolute shrinkage and selection operator Cox regression will then be used to select key predictors.
An extreme gradient boosting model will be optimized using five-fold cross-validation. Internal validation will be performed using 200 bootstrap resamples. An earlier cohort of 45 patients with high-risk GIST from the same center will initially serve as an external validation set. Model performance will be evaluated using the area under the curve, concordance index, calibration curves, accuracy, sensitivity, and specificity.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Tumor-Informed ctDNA-Based MRD Testing, Contrast-Enhanced CT
- Keywords
- Gastrointestinal Stromal Tumors, Minimal Residual Disease, Adjuvant Therapy, Prognosis, Liquid Biopsy
- Medical subject headings
- Gastrointestinal Stromal Tumors, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor-Informed ctDNA-Based MRD TestingDiagnostic test
Patient-specific variants will be selected from tumor tissue sequencing and used for serial ctDNA-based MRD testing of peripheral blood samples during follow-up. MRD results are investigational and will not independently guide treatment decisions.
Contrast-Enhanced CTDiagnostic test
Contrast-enhanced CT will be performed before enrollment to confirm no evidence of disease and every 3 months during 3 years of follow-up. MRI or PET-CT may be used when needed. Imaging-confirmed recurrence will be reviewed by a multidisciplinary team.
| Study group | Role | What they receive |
|---|---|---|
| High-Risk GIST MRD Monitoring Cohort | Patients with high-risk gastrointestinal stromal tumor who have undergone R0 resection of the primary tumor and are not currently receiving postoperative adjuvant therapy will undergo serial blood-based ctDNA-MRD testing and routine imaging follow-up for 3 years. The study will not assign or modify treatment. Receives: Diagnostic Test: Tumor-Informed ctDNA-Based MRD Testing; Diagnostic Test: Contrast-Enhanced CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Between MRD and Contrast-Enhanced CT Recurrence Assessments
At each scheduled follow-up visit, agreement between MRD status (positive or negative) and recurrence status determined by contrast-enhanced CT and multidisciplinary review will be evaluated using Cohen's kappa coefficient with a 95% confidence interval.
Measured: From baseline through 3 years of follow-up or until imaging-confirmed recurrence.
Three-Year Recurrence Rate
The percentage of participants with local recurrence or distant metastasis confirmed by contrast-enhanced CT and multidisciplinary review during the 3-year follow-up period.
Measured: At the end of the 3-year follow-up.
Secondary outcomes (7)
Predictive Performance of MRD for Imaging-Confirmed Recurrence
Using recurrence confirmed by contrast-enhanced CT and multidisciplinary review as the reference standard, MRD sensitivity, specificity, positive predictive value, and negative predictive value will be calculated.
Measured: From baseline through the end of the 3-year follow-up.
Lead Time From MRD Positivity to CT-Confirmed Recurrence
Among participants with imaging-confirmed recurrence and an earlier MRD-positive result, the interval between the first MRD-positive result and the first CT-confirmed recurrence will be calculated.
Measured: During the 3-year follow-up, through the first CT-confirmed recurrence.
Recurrence-Free Survival
Recurrence-free survival is defined as the time from the date of surgery to the first imaging-confirmed local recurrence or distant metastasis.
Measured: From the date of surgery through the end of the 3-year follow-up.
Overall Survival
Overall survival is defined as the time from the date of surgery to death from any cause. Participants who remain alive will be censored at the date they were last known to be alive.
Measured: From the date of surgery through the end of the 3-year follow-up.
Longitudinal Changes in ctDNA-MRD Genomic Features
Detected ctDNA variants and ctDNA levels will be summarized at protocol-specified time points. Their longitudinal changes and associations with recurrence-free survival and overall survival will be explored.
Measured: At baseline and protocol-specified follow-up visits for up to 3 years.
MRD Positivity According to Clinicopathological and Genomic Factors
MRD positivity will be assessed according to clinicopathological features, tumor genomic features, and ctDNA-MRD characteristics. Univariable and multivariable analyses will be used to identify factors associated with MRD positivity.
Measured: After completion of the 3-year follow-up and data collection.
Performance of the Recurrence-Risk Prediction Model
Model performance will be evaluated using the area under the receiver operating characteristic curve, concordance index with 95% confidence intervals, calibration curves, accuracy, sensitivity, and specificity.
Measured: After completion of the 3-year follow-up and model development and validation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Jun 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Why it stopped: Enrollment has been temporarily paused pending ethics review and implementation of the revised study protocol. Follow-up of previously enrolled participants is continuing.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhidong Gao, Peking University People's Hospital
- Investigators
- Zhidong Gao, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867901
- Sponsor's protocol ID
- 21510004487
- Other IDs
- 2026-2-408
- Status last verified
- Aug 2026
- First submitted
- 23 Apr 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gao ZD, Cheng BS, Bao YD, et al. Personalized tumor-informed circulating tumor DNA analysis in monitoring recurrence following resection of high-risk stage II-III gastrointestinal stromal tumor. J Clin Oncol. 2024;42(16 Suppl):11534.
Dermawan JK, Kelly C, Gao Z, Smith S, Jadeja B, Singer S, Tap WD, Chi P, Antonescu CR. Novel Genomic Risk Stratification Model for Primary Gastrointestinal Stromal Tumors (GIST) in the Adjuvant Therapy Era. Clin Cancer Res. 2023 Oct 2;29(19):3974-3985. doi: 10.1158/1078-0432.CCR-23-1184.
PubMed 37477937Jilg S, Rassner M, Maier J, Waldeck S, Kehl V, Follo M, Philipp U, Sauter A, Specht K, Mitschke J, Lange T, Bauer S, Jost PJ, Peschel C, Duyster J, Gaiser T, Hohenberger P, von Bubnoff N. Circulating cKIT and PDGFRA DNA indicates disease activity in Gastrointestinal Stromal Tumor (GIST). Int J Cancer. 2019 Oct 15;145(8):2292-2303. doi: 10.1002/ijc.32282. Epub 2019 Apr 29.
PubMed 30882891Blay JY, Schiffler C, Bouche O, Brahmi M, Duffaud F, Toulmonde M, Landi B, Lahlou W, Pannier D, Bompas E, Bertucci F, Chaigneau L, Collard O, Pracht M, Henon C, Ray-Coquard I, Armoun K, Salas S, Spalato-Ceruso M, Adenis A, Verret B, Penel N, Moreau-Bachelard C, Italiano A, Dufresne A, Metzger S, Chabaud S, Perol D, Le Cesne A. A randomized study of 6 versus 3 years of adjuvant imatinib in patients with localized GIST at high risk of relapse. Ann Oncol. 2024 Dec;35(12):1157-1168. doi: 10.1016/j.annonc.2024.08.2343. Epub 2024 Sep 4.
PubMed 39241959Dematteo RP, Ballman KV, Antonescu CR, Maki RG, Pisters PW, Demetri GD, Blackstein ME, Blanke CD, von Mehren M, Brennan MF, Patel S, McCarter MD, Polikoff JA, Tan BR, Owzar K; American College of Surgeons Oncology Group (ACOSOG) Intergroup Adjuvant GIST Study Team. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Mar 28;373(9669):1097-104. doi: 10.1016/S0140-6736(09)60500-6. Epub 2009 Mar 18.
PubMed 19303137Joensuu H, Vehtari A, Riihimaki J, Nishida T, Steigen SE, Brabec P, Plank L, Nilsson B, Cirilli C, Braconi C, Bordoni A, Magnusson MK, Linke Z, Sufliarsky J, Federico M, Jonasson JG, Dei Tos AP, Rutkowski P. Risk of recurrence of gastrointestinal stromal tumour after surgery: an analysis of pooled population-based cohorts. Lancet Oncol. 2012 Mar;13(3):265-74. doi: 10.1016/S1470-2045(11)70299-6. Epub 2011 Dec 6.
PubMed 22153892
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Predicting Recurrence Risk of Postoperative High-risk Gastrointestinal Stromal Tumors in NED State Based on Minimal Residual Disease Detection Via Liquid Biopsy
- ClinicalTrials.gov ID
- NCT05867901
- Acronym / sponsor ID
- 21510004487
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- Gastrointestinal Stromal Tumors, Minimal Residual Disease, Adjuvant Therapy, Prognosis, Liquid Biopsy
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Enrollment has been temporarily paused pending ethics review and implementation of the revised study protocol. Follow-up of previously enrolled participants is continuing.
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this single-center, prospective, observational cohort study is to learn whether tumor-informed minimal residual disease (MRD) testing in blood can predict recurrence in 66 patients with high-risk gastrointestinal stromal tumor (GIST) who are not currently receiving postoperative adjuvant therapy. The main questions it aims to answer are:
Can changes in MRD during follow-up predict tumor recurrence? How closely do MRD results agree with contrast-enhanced computed tomography (CT) findings, and can MRD identify recurrence earlier than CT? Can tumor genomic features, changes in MRD, and clinicopathological features be combined to develop a model for predicting recurrence risk? Participants will have their surgical tumor tissue analyzed, provide blood samples for MRD testing, and undergo regular clinical follow-up and contrast-enhanced CT examinations for 3 years. Participants may choose to receive and discuss their MRD results. This study will not assign or change treatment based on MRD results. Recurrence and treatment decisions will remain based on routine clinical assessment, primarily contrast-enhanced CT and multidisciplinary review.
Detailed description
This is a single-center, prospective, single-cohort, non-interventional observational study. The prospective cohort will include 66 patients with high-risk gastrointestinal stromal tumor (GIST) who have undergone R0 resection of the primary tumor. Eligible patients will either have no plan to receive postoperative adjuvant therapy or meet protocol-defined eligibility criteria after discontinuing such therapy.
Baseline tumor tissue will undergo whole-exome sequencing (WES) and next-generation sequencing (NGS). Fifty patient-specific variants associated with tumor development, progression, and individualized treatment will be selected to construct a personalized testing module. Cell-free DNA from peripheral blood will be analyzed using unique molecular identifier-based ultra-deep targeted NGS at a sequencing depth of approximately 100,000×. MRD positivity is defined as the detection of at least two significant loci with P ≤ 0.005.
Baseline contrast-enhanced computed tomography (CT) will confirm no evidence of disease before enrollment. Contrast-enhanced CT will be repeated every 3 months during 3 years of follow-up. Magnetic resonance imaging or positron emission tomography-CT may be performed when needed. Two experienced radiologists will independently review the CT images. Disagreements will be adjudicated by a third radiologist. Imaging recurrence will be evaluated according to Response Evaluation Criteria in Solid Tumors version 1.1 and confirmed by a multidisciplinary team.
Blood-based MRD testing will be performed at baseline and at protocol-specified follow-up visits. The study will compare MRD results with CT-based recurrence assessments and evaluate the predictive performance of MRD. It will also estimate the interval between the first MRD signal of recurrence and CT-confirmed recurrence.
The study will not assign or modify treatment. Participants who choose to receive their MRD results will receive a standardized explanation that the results are investigational. MRD results cannot independently establish a diagnosis of recurrence or guide treatment decisions. Participants who initiate a tyrosine kinase inhibitor (TKI) before imaging-confirmed recurrence may remain in follow-up. The primary MRD performance analysis will include only MRD, imaging, and clinical data collected before TKI initiation. Post-TKI recurrence status will not be used to reclassify pre-TKI MRD results in the primary MRD performance analysis.
After 3-year outcomes become available, data from the 66 prospective participants and 49 retrospective cases will be used to develop a recurrence-risk prediction model. The combined cohort will be randomly divided into training and internal test sets using an 8:2 stratified split. Candidate variables will first be screened using area under the receiver operating characteristic curve and missingness criteria. Least absolute shrinkage and selection operator Cox regression will then be used to select key predictors.
An extreme gradient boosting model will be optimized using five-fold cross-validation. Internal validation will be performed using 200 bootstrap resamples. An earlier cohort of 45 patients with high-risk GIST from the same center will initially serve as an external validation set. Model performance will be evaluated using the area under the curve, concordance index, calibration curves, accuracy, sensitivity, and specificity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-Risk GIST MRD Monitoring Cohort | – | Diagnostic Test: Tumor-Informed ctDNA-Based MRD Testing, Diagnostic Test: Contrast-Enhanced CTPatients with high-risk gastrointestinal stromal tumor who have undergone R0 resection of the primary tumor and are not currently receiving postoperative adjuvant therapy will undergo serial blood-based ctDNA-MRD testing and routine imaging follow-up for 3 years. The study will not assign or modify treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (11 listed)
- Inclusion Criteria for the Prospective Study on Postoperative Minimal Residual Disease (MRD) Surveillance in High-Risk Gastrointestinal Stromal Tumors (GIST) Without Adjuvant Therapy
- Aged 18-75 years.
- 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.
- Treatment-naive patients who have not previously received radiotherapy, chemotherapy, surgery, or any other anticancer treatment.
- Adequate hepatic, renal, and other major organ function, with the patient considered medically fit to undergo surgery.
Key exclusion criteria (12 listed)
- Exclusion Criteria for the Prospective Study on Postoperative Minimal Residual Disease (MRD) Surveillance in High-Risk Gastrointestinal Stromal Tumors (GIST) Without Adjuvant Therapy
- A history of another malignant tumor or the presence of another concurrent malignancy.
- Emergency surgery required because of intestinal obstruction, perforation, bleeding, or a similar condition.
- Pregnancy or breastfeeding.
- A history of severe psychiatric illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor-Informed ctDNA-Based MRD TestingPatient-specific variants will be selected from tumor tissue sequencing and used for serial ctDNA-based MRD testing of peripheral blood samples during follow-up. MRD results are investigational and will not independently guide treatment decisions. | Diagnostic test | High-Risk GIST MRD Monitoring Cohort |
| Contrast-Enhanced CTContrast-enhanced CT will be performed before enrollment to confirm no evidence of disease and every 3 months during 3 years of follow-up. MRI or PET-CT may be used when needed. Imaging-confirmed recurrence will be reviewed by a multidisciplinary team. | Diagnostic test | High-Risk GIST MRD Monitoring Cohort |
Primary outcome
Agreement Between MRD and Contrast-Enhanced CT Recurrence Assessments
Time frame: From baseline through 3 years of follow-up or until imaging-confirmed recurrence.
At each scheduled follow-up visit, agreement between MRD status (positive or negative) and recurrence status determined by contrast-enhanced CT and multidisciplinary review will be evaluated using Cohen's kappa coefficient with a 95% confidence interval.
Three-Year Recurrence Rate
Time frame: At the end of the 3-year follow-up.
The percentage of participants with local recurrence or distant metastasis confirmed by contrast-enhanced CT and multidisciplinary review during the 3-year follow-up period.
7 secondary outcomes
Predictive Performance of MRD for Imaging-Confirmed Recurrence
Time frame: From baseline through the end of the 3-year follow-up.
Lead Time From MRD Positivity to CT-Confirmed Recurrence
Time frame: During the 3-year follow-up, through the first CT-confirmed recurrence.
Recurrence-Free Survival
Time frame: From the date of surgery through the end of the 3-year follow-up.
Overall Survival
Time frame: From the date of surgery through the end of the 3-year follow-up.
Longitudinal Changes in ctDNA-MRD Genomic Features
Time frame: At baseline and protocol-specified follow-up visits for up to 3 years.
MRD Positivity According to Clinicopathological and Genomic Factors
Time frame: After completion of the 3-year follow-up and data collection.
Performance of the Recurrence-Risk Prediction Model
Time frame: After completion of the 3-year follow-up and model development and validation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- BackgroundGao ZD, Cheng BS, Bao YD, et al. Personalized tumor-informed circulating tumor DNA analysis in monitoring recurrence following resection of high-risk stage II-III gastrointestinal stromal tumor. J Clin Oncol. 2024;42(16 Suppl):11534.
- Background: PubMed 37477937Dermawan JK, Kelly C, Gao Z, Smith S, Jadeja B, Singer S, Tap WD, Chi P, Antonescu CR. Novel Genomic Risk Stratification Model for Primary Gastrointestinal Stromal Tumors (GIST) in the Adjuvant Therapy Era. Clin Cancer Res. 2023 Oct 2;29(19):3974-3985. doi: 10.1158/1078-0432.CCR-23-1184.
- Background: PubMed 30882891Jilg S, Rassner M, Maier J, Waldeck S, Kehl V, Follo M, Philipp U, Sauter A, Specht K, Mitschke J, Lange T, Bauer S, Jost PJ, Peschel C, Duyster J, Gaiser T, Hohenberger P, von Bubnoff N. Circulating cKIT and PDGFRA DNA indicates disease activity in Gastrointestinal Stromal Tumor (GIST). Int J Cancer. 2019 Oct 15;145(8):2292-2303. doi: 10.1002/ijc.32282. Epub 2019 Apr 29.
- Background: PubMed 39241959Blay JY, Schiffler C, Bouche O, Brahmi M, Duffaud F, Toulmonde M, Landi B, Lahlou W, Pannier D, Bompas E, Bertucci F, Chaigneau L, Collard O, Pracht M, Henon C, Ray-Coquard I, Armoun K, Salas S, Spalato-Ceruso M, Adenis A, Verret B, Penel N, Moreau-Bachelard C, Italiano A, Dufresne A, Metzger S, Chabaud S, Perol D, Le Cesne A. A randomized study of 6 versus 3 years of adjuvant imatinib in patients with localized GIST at high risk of relapse. Ann Oncol. 2024 Dec;35(12):1157-1168. doi: 10.1016/j.annonc.2024.08.2343. Epub 2024 Sep 4.
- Background: PubMed 19303137Dematteo RP, Ballman KV, Antonescu CR, Maki RG, Pisters PW, Demetri GD, Blackstein ME, Blanke CD, von Mehren M, Brennan MF, Patel S, McCarter MD, Polikoff JA, Tan BR, Owzar K; American College of Surgeons Oncology Group (ACOSOG) Intergroup Adjuvant GIST Study Team. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Mar 28;373(9669):1097-104. doi: 10.1016/S0140-6736(09)60500-6. Epub 2009 Mar 18.
- Background: PubMed 22153892Joensuu H, Vehtari A, Riihimaki J, Nishida T, Steigen SE, Brabec P, Plank L, Nilsson B, Cirilli C, Braconi C, Bordoni A, Magnusson MK, Linke Z, Sufliarsky J, Federico M, Jonasson JG, Dei Tos AP, Rutkowski P. Risk of recurrence of gastrointestinal stromal tumour after surgery: an analysis of pooled population-based cohorts. Lancet Oncol. 2012 Mar;13(3):265-74. doi: 10.1016/S1470-2045(11)70299-6. Epub 2011 Dec 6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhidong Gao, MD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Stromal Tumors, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between MRD and Contrast-Enhanced CT Recurrence Assessments (time frame: From baseline through 3 years of follow-up or until imaging-confirmed recurrence.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05867901, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.