Stomach NeoplasmsNCT04511559
Methylation Analysis of Circulating Tumor DNA in Gastric Cancer
An observational study of Stomach Neoplasms and Circulating Tumor DNA, run by Shanghai Zhongshan Hospital.
Trial summary
The primary purpose of this trial is to describe the profile of ctDNA methylation in gastric cancer. The second purpose is to demonstrate the correlation between the plasma ctDNA methylation status and the diagnosis and prognosis of patients with early and intermediate stage gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stomach Neoplasms, Circulating Tumor DNA
- What is being tested?
- Circulating Tumor DNA Methylation Sequencing and tissue DNA Methylation Sequencing
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 May 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have been referred to the participating study sites for upper GI endoscopy for standard clinical indications.
Who may be able to join
- The subject is scheduled to undergo an endoscopy because of medical indications.
- The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
- The subject must be willing and able to comply with all study procedures.
Who cannot join
- The subject who is unable to undergo gastroscopy.
- The subject with previous total or partial gastrectomy.
- The subject has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgment of the investigator would make the subject unsuitable for entry into the study.
- The subject is unwilling or unable to provide signed informed consent.
- The subject who is pregnant.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Methylation Analysis of Circulating Tumor DNA in Early Diagnosis and Prognostic Stratification in Patients With Gastric Cancer
The primary purpose of this trial is to describe the profile of ctDNA methylation in gastric cancer. The second purpose is to demonstrate the correlation between the plasma ctDNA methylation status and the diagnosis and prognosis of patients with early and intermediate stage gastric cancer.
Read the detailed description
Gastric cancer represents one of the common malignant tumors in China, with high incidence and mortality rates. Surgery is the conventional treatment option for early and intermediate stage gastric cancer, but the diagnosis in the early stage of gastric cancer remains a challenge to clinical practitioners. Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of 166 bp, mixed with cell-free DNA (cfDNA) of other sources in blood circulation. ctDNA is reflecting the most up-to-date status of the tumor genome. Hence, it is considered as a novel biomarker for tumors, which can be qualitative, quantitative, and used for disease monitoring. This study is designed to evaluate the potential clinical utility of circulating tumor DNA (ctDNA) as a clinical index in the diagnosis and prognosis of gastric cancer. The primary purpose of this trial is to describe the profile of ctDNA methylation in gastric cancer. The second purpose is to demonstrate the correlation between the plasma ctDNA methylation status and the diagnosis and prognosis of patients with early and intermediate stage gastric cancer.
- Conditions
- Stomach Neoplasms, Circulating Tumor DNA
- Being tested
- Circulating Tumor DNA Methylation Sequencing, tissue DNA Methylation Sequencing
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating Tumor DNA Methylation SequencingDiagnostic test
Whole blood collection through venipuncture. DNA methylation levels by deep sequencing.
tissue DNA Methylation SequencingDiagnostic test
Isolate DNA from tissue samples from subjects. DNA methylation levels by deep sequencing.
| Study group | Role | What they receive |
|---|---|---|
| chronic gastritis | This group will include 80 patients with chronic gastritis and the diagnoses will be based on the British Society of Gastroenterology guidelines. Receives: Diagnostic Test: Circulating Tumor DNA Methylation Sequencing; Diagnostic Test: tissue DNA Methylation Sequencing | |
| Moderate to severe atrophy/intestinal metaplasia/ | This group will include 80 patients with Moderate to severe atrophy/intestinal metaplasia/ and the diagnoses will be based on British Society of Gastroenterology guidelines. Receives: Diagnostic Test: Circulating Tumor DNA Methylation Sequencing; Diagnostic Test: tissue DNA Methylation Sequencing | |
| gastric cancer | This group will include 380 patients with gastric cancer and the diagnoses will be based on British Society of Gastroenterology guidelines. Receives: Diagnostic Test: Circulating Tumor DNA Methylation Sequencing; Diagnostic Test: tissue DNA Methylation Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis ctDNA methylation status and its Correlation to early diagnosis and prognostic evaluation of gastric cancer.
We will develop the linear model and a threshold value differentiating gastric cancer from control based on the 100 patient training set.
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511559
- Sponsor's protocol ID
- ZS-DL-202001
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Diaz LA Jr, Bardelli A. Liquid biopsies: genotyping circulating tumor DNA. J Clin Oncol. 2014 Feb 20;32(6):579-86. doi: 10.1200/JCO.2012.45.2011. Epub 2014 Jan 21.
PubMed 24449238Kilgour E, Rothwell DG, Brady G, Dive C. Liquid Biopsy-Based Biomarkers of Treatment Response and Resistance. Cancer Cell. 2020 Apr 13;37(4):485-495. doi: 10.1016/j.ccell.2020.03.012.
PubMed 32289272Gao Y, Zhang K, Xi H, Cai A, Wu X, Cui J, Li J, Qiao Z, Wei B, Chen L. Diagnostic and prognostic value of circulating tumor DNA in gastric cancer: a meta-analysis. Oncotarget. 2017 Jan 24;8(4):6330-6340. doi: 10.18632/oncotarget.14064.
PubMed 28009985
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylation Analysis of Circulating Tumor DNA in Early Diagnosis and Prognostic Stratification in Patients With Gastric Cancer
- ClinicalTrials.gov ID
- NCT04511559
- Acronym / sponsor ID
- ZS-DL-202001
- Conditions
- Stomach Neoplasms, Circulating Tumor DNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 13 Aug 2020 (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 primary purpose of this trial is to describe the profile of ctDNA methylation in gastric cancer. The second purpose is to demonstrate the correlation between the plasma ctDNA methylation status and the diagnosis and prognosis of patients with early and intermediate stage gastric cancer.
Detailed description
Gastric cancer represents one of the common malignant tumors in China, with high incidence and mortality rates. Surgery is the conventional treatment option for early and intermediate stage gastric cancer, but the diagnosis in the early stage of gastric cancer remains a challenge to clinical practitioners. Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of 166 bp, mixed with cell-free DNA (cfDNA) of other sources in blood circulation. ctDNA is reflecting the most up-to-date status of the tumor genome. Hence, it is considered as a novel biomarker for tumors, which can be qualitative, quantitative, and used for disease monitoring. This study is designed to evaluate the potential clinical utility of circulating tumor DNA (ctDNA) as a clinical index in the diagnosis and prognosis of gastric cancer. The primary purpose of this trial is to describe the profile of ctDNA methylation in gastric cancer. The second purpose is to demonstrate the correlation between the plasma ctDNA methylation status and the diagnosis and prognosis of patients with early and intermediate stage gastric cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| chronic gastritis | – | Diagnostic Test: Circulating Tumor DNA Methylation Sequencing, Diagnostic Test: tissue DNA Methylation SequencingThis group will include 80 patients with chronic gastritis and the diagnoses will be based on the British Society of Gastroenterology guidelines. |
| Moderate to severe atrophy/intestinal metaplasia/ | – | Diagnostic Test: Circulating Tumor DNA Methylation Sequencing, Diagnostic Test: tissue DNA Methylation SequencingThis group will include 80 patients with Moderate to severe atrophy/intestinal metaplasia/ and the diagnoses will be based on British Society of Gastroenterology guidelines. |
| gastric cancer | – | Diagnostic Test: Circulating Tumor DNA Methylation Sequencing, Diagnostic Test: tissue DNA Methylation SequencingThis group will include 380 patients with gastric cancer and the diagnoses will be based on British Society of Gastroenterology guidelines. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been referred to the participating study sites for upper GI endoscopy for standard clinical indications.
Key inclusion criteria (3 listed)
- The subject is scheduled to undergo an endoscopy because of medical indications.
- The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
- The subject must be willing and able to comply with all study procedures.
Key exclusion criteria (5 listed)
- The subject who is unable to undergo gastroscopy.
- The subject with previous total or partial gastrectomy.
- The subject has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgment of the investigator would make the subject unsuitable for entry into the study.
- The subject is unwilling or unable to provide signed informed consent.
- The subject who is pregnant.
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 |
|---|---|---|
| Circulating Tumor DNA Methylation SequencingWhole blood collection through venipuncture. DNA methylation levels by deep sequencing. | Diagnostic test | Moderate to severe atrophy/intestinal metaplasia/, chronic gastritis, gastric cancer |
| tissue DNA Methylation SequencingIsolate DNA from tissue samples from subjects. DNA methylation levels by deep sequencing. | Diagnostic test | Moderate to severe atrophy/intestinal metaplasia/, chronic gastritis, gastric cancer |
Primary outcome
Analysis ctDNA methylation status and its Correlation to early diagnosis and prognostic evaluation of gastric cancer.
Time frame: 1-2 years
We will develop the linear model and a threshold value differentiating gastric cancer from control based on the 100 patient training set.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 24449238Diaz LA Jr, Bardelli A. Liquid biopsies: genotyping circulating tumor DNA. J Clin Oncol. 2014 Feb 20;32(6):579-86. doi: 10.1200/JCO.2012.45.2011. Epub 2014 Jan 21.
- Background: PubMed 32289272Kilgour E, Rothwell DG, Brady G, Dive C. Liquid Biopsy-Based Biomarkers of Treatment Response and Resistance. Cancer Cell. 2020 Apr 13;37(4):485-495. doi: 10.1016/j.ccell.2020.03.012.
- Background: PubMed 28009985Gao Y, Zhang K, Xi H, Cai A, Wu X, Cui J, Li J, Qiao Z, Wei B, Chen L. Diagnostic and prognostic value of circulating tumor DNA in gastric cancer: a meta-analysis. Oncotarget. 2017 Jan 24;8(4):6330-6340. doi: 10.18632/oncotarget.14064.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasms and Circulating Tumor DNA, run by Shanghai Zhongshan Hospital.
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 3 inclusion and 5 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 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Ling Dong, M.D. & Ph.D. (+8613916877798, dong.ling@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis ctDNA methylation status and its Correlation to early diagnosis and prognostic evaluation of gastric cancer. (time frame: 1-2 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 NCT04511559, which also lists 4 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 13 Aug 2020.