Gastric CancerMRD-GCNCT06893133
ctDNA-MRD Monitoring After Resection in Gastric Cancer
An observational study of Gastric Cancer, run by Peking University at 1 site in China.
Trial summary
Numerous studies have demonstrated that circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) detection has significant clinical value in postoperative recurrence monitoring, adjuvant treatment decision-making, and early intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2025to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 110 patients with gastric cancer undergoing preoperative drug therapy combined with R0 resection were enrolled.
Who may be able to join
- Patients have received neoadjuvant therapy and radical resection (R0).
- Pathologically confirmed ypTNM stage II-III gastric or gastroesophageal junction adenocarcinoma.
- Patients must be able to provide sufficient fresh tissue/biopsies or minimum 5-10 FFPE sections for NGS-WES analysis.
- Patients must be able to follow the study visit schedule and be willing to cooperate with the study by providing blood samples at the indicated time point.
Who cannot join
- Patients who could not receive enhanced CT, gastroscopy and other routine review after surgery.
- Patients who could not perform WES or ctDNA-MRD detection for various reasons after surgery.
- Other cases considered unsuitable for inclusion by researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100142
Yongning Jia Associate Chief Physician, Dr., 0086-10-88121122, yongningjia@bjmu.edu.cn
Honglin Zhu, Dr., 0086-10-88121122, honglinzhu@hsc.pku.edu.cn
About this study
Official title: Personalized ctDNA-MRD in Recurrence Monitoring for Gastric Cancer Patients Undergoing Perioperative Treatment Combined With Curative Surgical Resection
Numerous studies have demonstrated that circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) detection has significant clinical value in postoperative recurrence monitoring, adjuvant treatment decision-making, and early intervention. Our previous retrospective study, using fixed ctDNA-MRD, confirmed that postoperative ctDNA-MRD can predict recurrence risk. Therefore, we plan to conduct a further prospective, multicenter, observational study, utilizing a combination of personalized ctDNA-MRD and fixed MRD panels, to dynamically monitor gastric cancer patients who have received neoadjuvant therapy followed by curative resection. The study will systematically analyze the correlation between ctDNA-MRD status and tumor recurrence and metastasis, assess its sensitivity and specificity in recurrence prediction, and compare its early warning advantage over traditional imaging techniques in predicting recurrence.
Read the detailed description
China has the highest incidence and mortality rates of gastric cancer in the world, with approximately 70% of patients diagnosed at an advanced stage. Perioperative treatment combined with surgery is the recommended treatment approach for advanced gastric cancer. However, a considerable proportion of patients still experience recurrence and metastasis after surgery. Imaging studies are the standard method for monitoring postoperative recurrence and metastasis, but they can only detect recurrence once the metastatic lesions have grown to a certain size. In contrast, ctDNA-MRD testing can detect residual tumor molecular signals in the blood, providing early signs of recurrence and allowing for timely intervention while the tumor is still in its "incipient stage." Previous clinical data have shown that MRD testing can identify recurrent and metastatic patients months earlier than traditional imaging methods, with the median lead time varying by cancer type: 9.5 months for breast cancer, 8.7 months for colon cancer, 5.2 months for lung cancer, and 2.8 months for bladder cancer.
Therefore, we plan to conduct a further prospective, multicenter, observational study, utilizing a combination of personalized ctDNA-MRD and fixed MRD panels, to dynamically monitor gastric cancer patients who have received neoadjuvant therapy followed by curative resection. The study will systematically analyze the correlation between ctDNA-MRD status and tumor recurrence and metastasis, assess its sensitivity and specificity in recurrence prediction, and compare its early warning advantage over traditional imaging techniques in predicting recurrence. In addition, this project will focus on establishing and improving a dynamic MRD monitoring system, laying the foundation for future interventional clinical research.
- Conditions
- Gastric Cancer
- Keywords
- ctDNA, MRD, Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative drug therapy combined with R0 resection in patients with gastric cancer | Names: MRD testing Description: MRD refers to the small, residual number of cancer cells that remain in a patient's body after treatment, often undetectable by conventional methods, but detectable using ctDNA. MRD-positive indicates the presence of residual disease, while MRD-negative suggests potential cure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Accuracy of Personalized ctDNA-MRD for Postoperative Recurrence
Sensitivity, Specificity, and Positive predictive value of ctDNA-MRD in predicting postoperative recurrence
Measured: From the time of surgical resection to the point of resurrence within 2 years
Secondary outcomes (1)
Lead time of personalized ctDNA-MRD compared to radiologic surveillance in postoperative recurrence prediction
Time interval between ctDNA-MRD positivity and imaging diagnosis of recurrence
Measured: From ctDNA-MRD positive to the point of CT imaging showing recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start8 Apr 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
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 Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziyu Li, MD, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893133
- Sponsor's protocol ID
- 2025KT40
- Acronym
- MRD-GC
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xia C, Dong X, Li H, Cao M, Sun D, He S, Yang F, Yan X, Zhang S, Li N, Chen W. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl). 2022 Feb 9;135(5):584-590. doi: 10.1097/CM9.0000000000002108.
PubMed 35143424Tarazona N, Gimeno-Valiente F, Gambardella V, Zuniga S, Rentero-Garrido P, Huerta M, Rosello S, Martinez-Ciarpaglini C, Carbonell-Asins JA, Carrasco F, Ferrer-Martinez A, Bruixola G, Fleitas T, Martin J, Tebar-Martinez R, Moro D, Castillo J, Espi A, Roda D, Cervantes A. Targeted next-generation sequencing of circulating-tumor DNA for tracking minimal residual disease in localized colon cancer. Ann Oncol. 2019 Nov 1;30(11):1804-1812. doi: 10.1093/annonc/mdz390.
PubMed 31562764Christensen E, Birkenkamp-Demtroder K, Sethi H, Shchegrova S, Salari R, Nordentoft I, Wu HT, Knudsen M, Lamy P, Lindskrog SV, Taber A, Balcioglu M, Vang S, Assaf Z, Sharma S, Tin AS, Srinivasan R, Hafez D, Reinert T, Navarro S, Olson A, Ram R, Dashner S, Rabinowitz M, Billings P, Sigurjonsson S, Andersen CL, Swenerton R, Aleshin A, Zimmermann B, Agerbaek M, Lin CJ, Jensen JB, Dyrskjot L. Early Detection of Metastatic Relapse and Monitoring of Therapeutic Efficacy by Ultra-Deep Sequencing of Plasma Cell-Free DNA in Patients With Urothelial Bladder Carcinoma. J Clin Oncol. 2019 Jun 20;37(18):1547-1557. doi: 10.1200/JCO.18.02052. Epub 2019 May 6.
PubMed 31059311Chaudhuri AA, Chabon JJ, Lovejoy AF, Newman AM, Stehr H, Azad TD, Khodadoust MS, Esfahani MS, Liu CL, Zhou L, Scherer F, Kurtz DM, Say C, Carter JN, Merriott DJ, Dudley JC, Binkley MS, Modlin L, Padda SK, Gensheimer MF, West RB, Shrager JB, Neal JW, Wakelee HA, Loo BW Jr, Alizadeh AA, Diehn M. Early Detection of Molecular Residual Disease in Localized Lung Cancer by Circulating Tumor DNA Profiling. Cancer Discov. 2017 Dec;7(12):1394-1403. doi: 10.1158/2159-8290.CD-17-0716. Epub 2017 Sep 24.
PubMed 28899864Reinert T, Henriksen TV, Christensen E, Sharma S, Salari R, Sethi H, Knudsen M, Nordentoft I, Wu HT, Tin AS, Heilskov Rasmussen M, Vang S, Shchegrova S, Frydendahl Boll Johansen A, Srinivasan R, Assaf Z, Balcioglu M, Olson A, Dashner S, Hafez D, Navarro S, Goel S, Rabinowitz M, Billings P, Sigurjonsson S, Dyrskjot L, Swenerton R, Aleshin A, Laurberg S, Husted Madsen A, Kannerup AS, Stribolt K, Palmelund Krag S, Iversen LH, Gotschalck Sunesen K, Lin CJ, Zimmermann BG, Lindbjerg Andersen C. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019 Aug 1;5(8):1124-1131. doi: 10.1001/jamaoncol.2019.0528.
PubMed 31070691Coombes RC, Page K, Salari R, Hastings RK, Armstrong A, Ahmed S, Ali S, Cleator S, Kenny L, Stebbing J, Rutherford M, Sethi H, Boydell A, Swenerton R, Fernandez-Garcia D, Gleason KLT, Goddard K, Guttery DS, Assaf ZJ, Wu HT, Natarajan P, Moore DA, Primrose L, Dashner S, Tin AS, Balcioglu M, Srinivasan R, Shchegrova SV, Olson A, Hafez D, Billings P, Aleshin A, Rehman F, Toghill BJ, Hills A, Louie MC, Lin CJ, Zimmermann BG, Shaw JA. Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence. Clin Cancer Res. 2019 Jul 15;25(14):4255-4263. doi: 10.1158/1078-0432.CCR-18-3663. Epub 2019 Apr 16.
PubMed 30992300
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized ctDNA-MRD in Recurrence Monitoring for Gastric Cancer Patients Undergoing Perioperative Treatment Combined With Curative Surgical Resection
- ClinicalTrials.gov ID
- NCT06893133
- Acronym / sponsor ID
- MRD-GC / 2025KT40
- Conditions
- Gastric Cancer
- Keywords
- ctDNA, MRD, Gastric Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 25 Mar 2025 (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.
Numerous studies have demonstrated that circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) detection has significant clinical value in postoperative recurrence monitoring, adjuvant treatment decision-making, and early intervention. Our previous retrospective study, using fixed ctDNA-MRD, confirmed that postoperative ctDNA-MRD can predict recurrence risk. Therefore, we plan to conduct a further prospective, multicenter, observational study, utilizing a combination of personalized ctDNA-MRD and fixed MRD panels, to dynamically monitor gastric cancer patients who have received neoadjuvant therapy followed by curative resection. The study will systematically analyze the correlation between ctDNA-MRD status and tumor recurrence and metastasis, assess its sensitivity and specificity in recurrence prediction, and compare its early warning advantage over traditional imaging techniques in predicting recurrence.
Detailed description
China has the highest incidence and mortality rates of gastric cancer in the world, with approximately 70% of patients diagnosed at an advanced stage. Perioperative treatment combined with surgery is the recommended treatment approach for advanced gastric cancer. However, a considerable proportion of patients still experience recurrence and metastasis after surgery. Imaging studies are the standard method for monitoring postoperative recurrence and metastasis, but they can only detect recurrence once the metastatic lesions have grown to a certain size. In contrast, ctDNA-MRD testing can detect residual tumor molecular signals in the blood, providing early signs of recurrence and allowing for timely intervention while the tumor is still in its "incipient stage." Previous clinical data have shown that MRD testing can identify recurrent and metastatic patients months earlier than traditional imaging methods, with the median lead time varying by cancer type: 9.5 months for breast cancer, 8.7 months for colon cancer, 5.2 months for lung cancer, and 2.8 months for bladder cancer.
Therefore, we plan to conduct a further prospective, multicenter, observational study, utilizing a combination of personalized ctDNA-MRD and fixed MRD panels, to dynamically monitor gastric cancer patients who have received neoadjuvant therapy followed by curative resection. The study will systematically analyze the correlation between ctDNA-MRD status and tumor recurrence and metastasis, assess its sensitivity and specificity in recurrence prediction, and compare its early warning advantage over traditional imaging techniques in predicting recurrence. In addition, this project will focus on establishing and improving a dynamic MRD monitoring system, laying the foundation for future interventional clinical research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative drug therapy combined with R0 resection in patients with gastric cancer | – | –Names: MRD testing Description: MRD refers to the small, residual number of cancer cells that remain in a patient's body after treatment, often undetectable by conventional methods, but detectable using ctDNA. MRD-positive indicates the presence of residual disease, while MRD-negative suggests potential cure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 110 patients with gastric cancer undergoing preoperative drug therapy combined with R0 resection were enrolled.
Key inclusion criteria (4 listed)
- Patients have received neoadjuvant therapy and radical resection (R0).
- Pathologically confirmed ypTNM stage II-III gastric or gastroesophageal junction adenocarcinoma.
- Patients must be able to provide sufficient fresh tissue/biopsies or minimum 5-10 FFPE sections for NGS-WES analysis.
- Patients must be able to follow the study visit schedule and be willing to cooperate with the study by providing blood samples at the indicated time point.
Key exclusion criteria (3 listed)
- Patients who could not receive enhanced CT, gastroscopy and other routine review after surgery.
- Patients who could not perform WES or ctDNA-MRD detection for various reasons after surgery.
- Other cases considered unsuitable for inclusion by researchers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive Accuracy of Personalized ctDNA-MRD for Postoperative Recurrence
Time frame: From the time of surgical resection to the point of resurrence within 2 years
Sensitivity, Specificity, and Positive predictive value of ctDNA-MRD in predicting postoperative recurrence
1 secondary outcome
Lead time of personalized ctDNA-MRD compared to radiologic surveillance in postoperative recurrence prediction
Time frame: From ctDNA-MRD positive to the point of CT imaging showing recurrence
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 35143424Xia C, Dong X, Li H, Cao M, Sun D, He S, Yang F, Yan X, Zhang S, Li N, Chen W. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl). 2022 Feb 9;135(5):584-590. doi: 10.1097/CM9.0000000000002108.
- Background: PubMed 31562764Tarazona N, Gimeno-Valiente F, Gambardella V, Zuniga S, Rentero-Garrido P, Huerta M, Rosello S, Martinez-Ciarpaglini C, Carbonell-Asins JA, Carrasco F, Ferrer-Martinez A, Bruixola G, Fleitas T, Martin J, Tebar-Martinez R, Moro D, Castillo J, Espi A, Roda D, Cervantes A. Targeted next-generation sequencing of circulating-tumor DNA for tracking minimal residual disease in localized colon cancer. Ann Oncol. 2019 Nov 1;30(11):1804-1812. doi: 10.1093/annonc/mdz390.
- Background: PubMed 31059311Christensen E, Birkenkamp-Demtroder K, Sethi H, Shchegrova S, Salari R, Nordentoft I, Wu HT, Knudsen M, Lamy P, Lindskrog SV, Taber A, Balcioglu M, Vang S, Assaf Z, Sharma S, Tin AS, Srinivasan R, Hafez D, Reinert T, Navarro S, Olson A, Ram R, Dashner S, Rabinowitz M, Billings P, Sigurjonsson S, Andersen CL, Swenerton R, Aleshin A, Zimmermann B, Agerbaek M, Lin CJ, Jensen JB, Dyrskjot L. Early Detection of Metastatic Relapse and Monitoring of Therapeutic Efficacy by Ultra-Deep Sequencing of Plasma Cell-Free DNA in Patients With Urothelial Bladder Carcinoma. J Clin Oncol. 2019 Jun 20;37(18):1547-1557. doi: 10.1200/JCO.18.02052. Epub 2019 May 6.
- Background: PubMed 28899864Chaudhuri AA, Chabon JJ, Lovejoy AF, Newman AM, Stehr H, Azad TD, Khodadoust MS, Esfahani MS, Liu CL, Zhou L, Scherer F, Kurtz DM, Say C, Carter JN, Merriott DJ, Dudley JC, Binkley MS, Modlin L, Padda SK, Gensheimer MF, West RB, Shrager JB, Neal JW, Wakelee HA, Loo BW Jr, Alizadeh AA, Diehn M. Early Detection of Molecular Residual Disease in Localized Lung Cancer by Circulating Tumor DNA Profiling. Cancer Discov. 2017 Dec;7(12):1394-1403. doi: 10.1158/2159-8290.CD-17-0716. Epub 2017 Sep 24.
- Background: PubMed 31070691Reinert T, Henriksen TV, Christensen E, Sharma S, Salari R, Sethi H, Knudsen M, Nordentoft I, Wu HT, Tin AS, Heilskov Rasmussen M, Vang S, Shchegrova S, Frydendahl Boll Johansen A, Srinivasan R, Assaf Z, Balcioglu M, Olson A, Dashner S, Hafez D, Navarro S, Goel S, Rabinowitz M, Billings P, Sigurjonsson S, Dyrskjot L, Swenerton R, Aleshin A, Laurberg S, Husted Madsen A, Kannerup AS, Stribolt K, Palmelund Krag S, Iversen LH, Gotschalck Sunesen K, Lin CJ, Zimmermann BG, Lindbjerg Andersen C. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019 Aug 1;5(8):1124-1131. doi: 10.1001/jamaoncol.2019.0528.
- Background: PubMed 30992300Coombes RC, Page K, Salari R, Hastings RK, Armstrong A, Ahmed S, Ali S, Cleator S, Kenny L, Stebbing J, Rutherford M, Sethi H, Boydell A, Swenerton R, Fernandez-Garcia D, Gleason KLT, Goddard K, Guttery DS, Assaf ZJ, Wu HT, Natarajan P, Moore DA, Primrose L, Dashner S, Tin AS, Balcioglu M, Srinivasan R, Shchegrova SV, Olson A, Hafez D, Billings P, Aleshin A, Rehman F, Toghill BJ, Hills A, Louie MC, Lin CJ, Zimmermann BG, Shaw JA. Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence. Clin Cancer Res. 2019 Jul 15;25(14):4255-4263. doi: 10.1158/1078-0432.CCR-18-3663. Epub 2019 Apr 16.
- 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.
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 Gastric Cancer, run by Peking University 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 21 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ziyu Li, MD.,PhD (0086-10-88121122, ziyu_li@hsc.pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Accuracy of Personalized ctDNA-MRD for Postoperative Recurrence (time frame: From the time of surgical resection to the point of resurrence within 2 years). 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 NCT06893133, 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 21 Apr 2026.