Circulating Tumor DNA (ctDNA)NCT05027347
Detection of Plasma Circulating Tumor DNA in Gastric Cancer
An observational study of Circulating Tumor DNA (ctDNA) and Gastric Cancer, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial summary
The aim of this study is to develop a protocol for detection of circulating tumor DNA (ctDNA) in plasma of patients with early stages of gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circulating Tumor DNA (ctDNA), Gastric Cancer
- What is being tested?
- plasma circulating tumor DNA
- How many people
- 200 participants
- Where
- 1 siteVietnam
- Study dates
- 10 Oct 2021to 30 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with early and locally advanced stage (I, II and IIIA) gastric cancer
Who may be able to join
- Male or Female patients aged 18 years and older
- Histologically proven stage (I, II and IIIA) gastric adenocarcinoma
- Naivety to treatment.
- No known other concomitant cancer diagnosis
- Signed informed consent
Who cannot join
- Pathologically late stage (stage IIIB and IV) or metastatic gastric adenocarcinoma
- Underwent any type of treatment
- Unable to undergo biopsy
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
University Medical Center Ho Chi Minh City
Ho Chi Minh City, 700000
Long D. Vo, MD., +84.918133915, long.vd@umc.edu.vn
About this study
The aim of this study is to develop a protocol for detection of circulating tumor DNA (ctDNA) in plasma of patients with early stages of gastric cancer.
Read the detailed description
Gastric cancer (GC) is the fifth most common cancer worldwide and the third leading cause of cancer deaths. Earlier detection of GC can dramatically increases the five-year survival rate up to > 90%. The current endoscopy and tissue biopsy remain excessively expensive for middle-income nations, in addition to being fairly invasive, with possible complications. Additionally, most of serum-based biomarkers such as carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), carbohydrate antigen 72-4 (CA72-4), and carbohydrate antigen 125 (CA125) are not recommended for detection of GC due to the limit of specificity and sensitivity in the early stages of GC. Thus, it is essential to identify new biomarkers for diagnosis of early stages of GC. In this study, the investigators develop an ultradeep massive parallel sequencing (MPS) assay to detect tumor derived mutations (TDM) in plasma of early stages of GC. This study provides proof-of-principle for eventual clinical employment of circulating DNA, via liquid biopsy, for detection of early stages of GC.
- Conditions
- Circulating Tumor DNA (ctDNA), Gastric Cancer
- Being tested
- plasma circulating tumor DNA
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma circulating tumor DNADiagnostic test
A liquid biopsy assay for identification of tumor derived mutations in plasma of gastric cancer
| Study group | Role | What they receive |
|---|---|---|
| 100 healthy people | 10 ml blood and tissue biopsy were collected from each patient Receives: Diagnostic Test: plasma circulating tumor DNA | |
| 100 gastric cancer patients | 10 ml blood and tissue biopsy were collected from each patient Receives: Diagnostic Test: plasma circulating tumor DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and and specificity of our mutation-based assay for detecting early-stage gastric cancer patients
sensitivity and and specificity of our mutation-based assay for detecting early-stage gastric cancer patients
Measured: 1 months after collecting blood and specimen
Secondary outcomes (2)
Limit of detection (LOD): the lowest variant allelic frequency that can be reliably detected
the lowest variant allelic frequency that can be reliably detected
Measured: 1 months after collecting blood and specimen
The concordance rate of mutation results between plasma and tissue biopsy assay
The concordance rate of mutation results between plasma and tissue biopsy
Measured: 1 months after collecting blood and specimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start10 Oct 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Tumor DNA (ctDNA)Studies 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
- 200 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
- NCT05027347
- Sponsor's protocol ID
- 79/GCN-HDDD 2021
- Status last verified
- Apr 2022
- First submitted
- 25 Aug 2021
- Last updated
- 28 Apr 2022
- Results posted
- 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 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Plasma Circulating Tumor DNA in Gastric Cancer
- ClinicalTrials.gov ID
- NCT05027347
- Acronym / sponsor ID
- 79/GCN-HDDD 2021
- Conditions
- Circulating Tumor DNA (ctDNA), Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 30 Aug 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.
The aim of this study is to develop a protocol for detection of circulating tumor DNA (ctDNA) in plasma of patients with early stages of gastric cancer.
Detailed description
Gastric cancer (GC) is the fifth most common cancer worldwide and the third leading cause of cancer deaths. Earlier detection of GC can dramatically increases the five-year survival rate up to > 90%. The current endoscopy and tissue biopsy remain excessively expensive for middle-income nations, in addition to being fairly invasive, with possible complications. Additionally, most of serum-based biomarkers such as carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), carbohydrate antigen 72-4 (CA72-4), and carbohydrate antigen 125 (CA125) are not recommended for detection of GC due to the limit of specificity and sensitivity in the early stages of GC. Thus, it is essential to identify new biomarkers for diagnosis of early stages of GC. In this study, the investigators develop an ultradeep massive parallel sequencing (MPS) assay to detect tumor derived mutations (TDM) in plasma of early stages of GC. This study provides proof-of-principle for eventual clinical employment of circulating DNA, via liquid biopsy, for detection of early stages of GC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 healthy people | – | Diagnostic Test: plasma circulating tumor DNA10 ml blood and tissue biopsy were collected from each patient |
| 100 gastric cancer patients | – | Diagnostic Test: plasma circulating tumor DNA10 ml blood and tissue biopsy were collected from each patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with early and locally advanced stage (I, II and IIIA) gastric cancer
Key inclusion criteria (5 listed)
- Male or Female patients aged 18 years and older
- Histologically proven stage (I, II and IIIA) gastric adenocarcinoma
- Naivety to treatment.
- No known other concomitant cancer diagnosis
- Signed informed consent
Key exclusion criteria (3 listed)
- Pathologically late stage (stage IIIB and IV) or metastatic gastric adenocarcinoma
- Underwent any type of treatment
- Unable to undergo biopsy
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 |
|---|---|---|
| plasma circulating tumor DNAA liquid biopsy assay for identification of tumor derived mutations in plasma of gastric cancer | Diagnostic test | 100 gastric cancer patients, 100 healthy people |
Primary outcome
The sensitivity and and specificity of our mutation-based assay for detecting early-stage gastric cancer patients
Time frame: 1 months after collecting blood and specimen
sensitivity and and specificity of our mutation-based assay for detecting early-stage gastric cancer patients
2 secondary outcomes
Limit of detection (LOD): the lowest variant allelic frequency that can be reliably detected
Time frame: 1 months after collecting blood and specimen
The concordance rate of mutation results between plasma and tissue biopsy assay
Time frame: 1 months after collecting blood and specimen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Circulating Tumor DNA (ctDNA)
RecruitingObservational study
Patient-Specific MRD Liquid Biopsy in Resected NSCLC: Plasma and Bronchial Washing ctDNA
Non-Small Cell Lung Cancer, Minimal Residual Disease
Recruiting
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
Breast Neoplasms, Carcinoma, Ductal, Breast
Not yet recruitingObservational study
Detection Technology of Peripheral Blood ctDNA Based on CRISPR/Cas and Gold Nanoparticles
Cancer, Circulating Tumor DNA Detection
RecruitingPhase 2
Circulating Tumor DNA Methylation-Guided Adjuvant Therapy Decision-Making in Patients With Resectable Colorectal Cancer Liver Metastases After Resection
Colorectal Cancer Liver Metastases (CRLM), ctDNA
RecruitingPhase 1
Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis
Pancreatic Ductal Adenocarcinoma (PDAC)
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.
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 Circulating Tumor DNA (ctDNA) and Gastric Cancer, 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 5 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: status not confirmed, as of the sponsor's last update on 28 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Long D. Vo, MD. (+84918133915, long.vd@umc.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and and specificity of our mutation-based assay for detecting early-stage gastric cancer patients (time frame: 1 months after collecting blood and specimen). 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 28 Apr 2022.