Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 12:13 AM
Study NCT ID:
NCT04511559
Status:
UNKNOWN
Last Update Posted:
2020-08-13
First Post:
2020-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methylation Analysis of Circulating Tumor DNA in Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 540}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-10', 'studyFirstSubmitDate': '2020-08-10', 'studyFirstSubmitQcDate': '2020-08-10', 'lastUpdatePostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis ctDNA methylation status and its Correlation to early diagnosis and prognostic evaluation of gastric cancer.', 'timeFrame': '1-2 years', 'description': 'We will develop the linear model and a threshold value differentiating gastric cancer from control based on the 100 patient training set.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stomach Neoplasms', 'Circulating Tumor DNA']}, 'referencesModule': {'references': [{'pmid': '30207593', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24449238', 'type': 'BACKGROUND', 'citation': 'Diaz 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.'}, {'pmid': '32289272', 'type': 'BACKGROUND', 'citation': 'Kilgour 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.'}, {'pmid': '28009985', 'type': 'BACKGROUND', 'citation': 'Gao 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have been referred to the participating study sites for upper GI endoscopy for standard clinical indications.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The subject is scheduled to undergo an endoscopy because of medical indications.\n2. 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.\n3. The subject must be willing and able to comply with all study procedures.\n\nExclusion Criteria:\n\n1. The subject who is unable to undergo gastroscopy.\n2. The subject with previous total or partial gastrectomy.\n3. 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.\n4. The subject is unwilling or unable to provide signed informed consent.\n5. The subject who is pregnant.'}, 'identificationModule': {'nctId': 'NCT04511559', 'briefTitle': 'Methylation Analysis of Circulating Tumor DNA in Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Methylation Analysis of Circulating Tumor DNA in Early Diagnosis and Prognostic Stratification in Patients With Gastric Cancer', 'orgStudyIdInfo': {'id': 'ZS-DL-202001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic gastritis', 'description': 'This group will include 80 patients with chronic gastritis and the diagnoses will be based on the British Society of Gastroenterology guidelines.', 'interventionNames': ['Diagnostic Test: Circulating Tumor DNA Methylation Sequencing', 'Diagnostic Test: tissue DNA Methylation Sequencing']}, {'label': 'Moderate to severe atrophy/intestinal metaplasia/', 'description': '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.', 'interventionNames': ['Diagnostic Test: Circulating Tumor DNA Methylation Sequencing', 'Diagnostic Test: tissue DNA Methylation Sequencing']}, {'label': 'gastric cancer', 'description': 'This group will include 380 patients with gastric cancer and the diagnoses will be based on British Society of Gastroenterology guidelines.', 'interventionNames': ['Diagnostic Test: Circulating Tumor DNA Methylation Sequencing', 'Diagnostic Test: tissue DNA Methylation Sequencing']}], 'interventions': [{'name': 'Circulating Tumor DNA Methylation Sequencing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Whole blood collection through venipuncture. DNA methylation levels by deep sequencing.', 'armGroupLabels': ['Moderate to severe atrophy/intestinal metaplasia/', 'chronic gastritis', 'gastric cancer']}, {'name': 'tissue DNA Methylation Sequencing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Isolate DNA from tissue samples from subjects. DNA methylation levels by deep sequencing.', 'armGroupLabels': ['Moderate to severe atrophy/intestinal metaplasia/', 'chronic gastritis', 'gastric cancer']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ling Dong, M.D. & Ph.D.', 'role': 'CONTACT', 'email': 'dong.ling@zs-hospital.sh.cn', 'phone': '+8613916877798'}, {'name': 'Ji-Min Zhu, M.D. & Ph.D.', 'role': 'CONTACT', 'email': 'zhu.jimin@zs-hospital.sh.cn', 'phone': '+8613611867273'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}