Gastric CancerNCT05029869
Monitoring Minimal Residual Disease in Gastric Cancer by Liquid Biopsy Study Description
An observational study of Gastric Cancer and ctDNA, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial summary
This study aims to evaluate the use of Next Generation Sequencing (NGS) to detect circulating tumor DNA in gastric cancer patients after gastrectomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, ctDNA
- What is being tested?
- ctDNA
- How many people
- 100 participants
- Where
- 1 siteVietnam
- Study dates
- 4 Oct 2021to 30 Dec 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed and untreated gastric adenocarcinoma
Who may be able to join
- Male or Female patients aged 18 years and older
- Histologically proven primary gastric adenocarcinoma before surgery
- Clinical stage is locally advanced cT2-4a any N and M0
- In initial evaluation, patient can undergo radical gastrectomy and lymphadenectomy
- No preoperative therapy, including chemotherapy and radiotherapy
- No known cancer diagnosis within last five years
- Signed informed consent
Who cannot join
- Gastrectomy cannot be achieved during operation due to metastasis
- Patient fails to follow-up and provide postoperative samples
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
University Medical Center Ho Chi Minh City
Ho Chi Minh City, 700000
About this study
Official title: Monitoring Minimal Residual Disease in Gastric Cancer by Liquid Biopsy
This study aims to evaluate the use of Next Generation Sequencing (NGS) to detect circulating tumor DNA in gastric cancer patients after gastrectomy
Read the detailed description
Gastric cancer is the fourth most common cancer in Vietnam with high mortality rate. Patients at early stages undergo radical gastrectomy with curative intent, but the remaining tumor cells, termed as minimal residual disease (MRD), can later cause relapse. Conventional methods to monitor MRD such as imaging and blood tests for biomarkers such as CEA are not sensitive and specific enough. ctDNA has recently emerged as a promising noninvasive marker with high accuracy to monitor MRD and detect relapse in many cancers such as breast and colorectal cancers. However, its application in gastric cancer has not been extensively evaluated. Therefore, this study aims to use advanced NGS technologies to detect ctDNA in liquid biopsy as a biomarker to monitor MRD after radical gastrectomy.
- Conditions
- Gastric Cancer, ctDNA
- Being tested
- ctDNA
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNADiagnostic test
The blood samples for ctDNA and other tumor markers will be first collected within 14 days before surgery, and then be tested after gastrectomy in scheduled interval
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of MRD detection using ctDNA as the biomarker
The percentage of positive ctDNA detection among participants who experience disease recurrence or metastasis
Measured: 2 years after surgery
The specificity of MRD detection using ctDNA as the biomarker
The percentage of positive ctDNA detection among participants who do not experience disease recurrence or metastasis
Measured: 2 years after surgery
Secondary outcomes (3)
Leading time between ctDNA detection and cancer recurrence detected by conventional methods
Time is measured between first positive ctDNA detection and first cancer recurrence detected by conventional methods
Measured: 2 years after surgery
Mean ctDNA level (MTM/ml) of gastric cancer before operation
The mean ctDNA level in gastric cancer patients before operation
Measured: Within 14 days before operation
Mutation profile of gastric cancer
Profiling of the most frequent gene mutations
Measured: Within 14 days before operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start4 Oct 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029869
- Sponsor's protocol ID
- 81/GCN-HDDD 2021
- Status last verified
- Jun 2025
- First submitted
- 25 Aug 2021
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Minimal Residual Disease in Gastric Cancer by Liquid Biopsy
- ClinicalTrials.gov ID
- NCT05029869
- Acronym / sponsor ID
- 81/GCN-HDDD 2021
- Conditions
- Gastric Cancer, ctDNA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Sep 2021 (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.
This study aims to evaluate the use of Next Generation Sequencing (NGS) to detect circulating tumor DNA in gastric cancer patients after gastrectomy
Detailed description
Gastric cancer is the fourth most common cancer in Vietnam with high mortality rate. Patients at early stages undergo radical gastrectomy with curative intent, but the remaining tumor cells, termed as minimal residual disease (MRD), can later cause relapse. Conventional methods to monitor MRD such as imaging and blood tests for biomarkers such as CEA are not sensitive and specific enough. ctDNA has recently emerged as a promising noninvasive marker with high accuracy to monitor MRD and detect relapse in many cancers such as breast and colorectal cancers. However, its application in gastric cancer has not been extensively evaluated. Therefore, this study aims to use advanced NGS technologies to detect ctDNA in liquid biopsy as a biomarker to monitor MRD after radical gastrectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed and untreated gastric adenocarcinoma
Key inclusion criteria (7 listed)
- Male or Female patients aged 18 years and older
- Histologically proven primary gastric adenocarcinoma before surgery
- Clinical stage is locally advanced cT2-4a any N and M0
- In initial evaluation, patient can undergo radical gastrectomy and lymphadenectomy
- No preoperative therapy, including chemotherapy and radiotherapy
Key exclusion criteria (2 listed)
- Gastrectomy cannot be achieved during operation due to metastasis
- Patient fails to follow-up and provide postoperative samples
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 |
|---|---|---|
| ctDNAThe blood samples for ctDNA and other tumor markers will be first collected within 14 days before surgery, and then be tested after gastrectomy in scheduled interval | Diagnostic test | – |
Primary outcome
The sensitivity of MRD detection using ctDNA as the biomarker
Time frame: 2 years after surgery
The percentage of positive ctDNA detection among participants who experience disease recurrence or metastasis
The specificity of MRD detection using ctDNA as the biomarker
Time frame: 2 years after surgery
The percentage of positive ctDNA detection among participants who do not experience disease recurrence or metastasis
3 secondary outcomes
Leading time between ctDNA detection and cancer recurrence detected by conventional methods
Time frame: 2 years after surgery
Mean ctDNA level (MTM/ml) of gastric cancer before operation
Time frame: Within 14 days before operation
Mutation profile of gastric cancer
Time frame: Within 14 days before operation
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 13 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and ctDNA, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
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 7 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2025. 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 Vietnam. 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?
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?
The sensitivity of MRD detection using ctDNA as the biomarker (time frame: 2 years after surgery). 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?
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 13 Aug 2025.