Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2026-01-22 @ 10:17 AM
Study NCT ID:
NCT04253106
Status:
COMPLETED
Last Update Posted:
2024-09-23
First Post:
2020-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liquid Biopsies for the Personalized Management of Patients with Hereditary Diffuse 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073890', 'term': 'Liquid Biopsy'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicentric, prospective non-randomized study prognostic aim. Control group planned to have standard values.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-20', 'studyFirstSubmitDate': '2020-01-31', 'studyFirstSubmitQcDate': '2020-01-31', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects in whom somatic mutations or methylation profiles are detected.', 'timeFrame': 'Over two years of surveillance'}], 'secondaryOutcomes': [{'measure': 'Replicability of observations over successive endoscopies. Correlation between blood and gastric fluid.', 'timeFrame': 'Over two years of surveillance'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastrectomy', 'somatic mutations', 'endoscopy', 'biopsies', 'methylation profil'], 'conditions': ['Hereditary Diffuse Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Activating somatic mutations and methylation profiles identified by liquid biopsies could identify CDH1 and CTNNA1 pathogenic variants carriers with invasive diffuse gastric cancer undetectable by upper G-I endoscopy.', 'detailedDescription': 'Carriers of germline pathogenic variants in the CDH1 and CTNNA1 genes have the Hereditary Diffuse Gastric Cancer Syndrome. Asymptomatic carriers have at high lifetime risk of diffuse gastric cancer (30-70%). Screening upper gastrointestinal endoscopy, even with multiple random biopsies, misses signet ring cell cancer foci. Invasive cancers can thus go undetected. There is therefore a recommendation of total risk-reducing gastrectomy, at least in carriers with a family history of gastric cancer. Novel screening strategies are needed. In this pilot project, the investigators will perform liquid biopsies of both blood and gastric fluid in asymptomatic carriers who refuse gastrectomy and in controls. The investigators aim to show that somatic mutations in a panel of genes involved in gastric cancer and methylation profiles are detected in a subset of carriers, and not in controls. These could be indicative of invasive cancer undetected by endoscopy, and would thus be a strong argument for risk-reducing gastrectomy. On the contrary, in the absence of somatic mutations in liquid biopsies, endoscopic surveillance could continue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCase:\n\n* Patient ≥ 18 years old\n* CDH1 or CTNNA1 germline pathogenic variant.\n* No history of diffuse gastric cancer.\n* French social security.\n* Ability to understand and willingness to sign a written informed consent document.\n\nVolunteers:\n\n* Patients ≥ 18 years old\n* Patients with no oncological history\n* Patients with macroscopically normal oeso-gastroduodenal fibroscopy\n* French social security.\n* Ability to understand and willingness to sign a written informed consent\n\nExclusion Criteria: for both arms\n\n* Patients with cancer being treated\n* Patients with metastatic cancer\n* Medical contraindication to general anesthesia or FOGD (bleeding disorder, pregnant women )\n* Patients under guardianship or curator'}, 'identificationModule': {'nctId': 'NCT04253106', 'acronym': 'LISA-HDGC', 'briefTitle': 'Liquid Biopsies for the Personalized Management of Patients with Hereditary Diffuse Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Liquid Biopsies (blood, Gastric Fluid) for the Personalized Management of Patients with Hereditary Diffuse Gastric Cancer: a Pilot Project', 'orgStudyIdInfo': {'id': 'APHP190483'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unaffected carriers of constitutional mutations', 'description': 'Patients with CDH1 or CTNNA1 germline pathogenic variant. No history of diffuse gastric cancer.', 'interventionNames': ['Genetic: Liquid biopsies (blood, gastric fluid).']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'All patients with FOGD', 'description': 'without observation of macroscopic lesions paired with cases (age and sex)', 'interventionNames': ['Genetic: Liquid biopsies (blood, gastric fluid).']}], 'interventions': [{'name': 'Liquid biopsies (blood, gastric fluid).', 'type': 'GENETIC', 'description': 'Next generation sequencing of a panel of diffuse gastric cancer genes, methylation analysis. Samples collected during routine screening endoscopy.', 'armGroupLabels': ['All patients with FOGD', 'Unaffected carriers of constitutional mutations']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'Hopital Pitié Salpetrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor.', 'ipdSharing': 'YES', 'description': 'The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l\\'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.\n\nConsultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.', 'accessCriteria': 'Researchers who provide a methodologically sound proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}