- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04253106
Liquid Biopsies for the Personalized Management of Patients With Hereditary Diffuse Gastric Cancer (LISA-HDGC)
January 10, 2024 updated by: Assistance Publique - Hôpitaux de Paris
Liquid Biopsies (Blood, Gastric Fluid) for the Personalized Management of Patients With Hereditary Diffuse Gastric Cancer: a Pilot Project
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: BENUSIGLIO Patrick, MD PhD
- Phone Number: 33142177659
- Email: patrick.benusiglio@aphp.fr
Study Locations
-
-
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Paris, France, 75013
- Hopital Pitie Salpetriere
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Case:
- Patient>18 years old
- CDH1 or CTNNA1 germline pathogenic variant.
- No history of diffuse gastric cancer.
- French social security.
- Ability to understand and willingness to sign a written informed consent document.
Volunteers:
- Patients > 18years old
- Patients with no oncological history
Exclusion Criteria: for both arms
- Patients with cancer being treated
- Patients with metastatic cancer
- Medical contraindication to general anesthesia or FOGD (bleeding disorder, pregnant women )
- Patients under guardianship or curator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Unaffected carriers of constitutional mutations
Patients with CDH1 or CTNNA1 germline pathogenic variant.
No history of diffuse gastric cancer.
|
Next generation sequencing of a panel of diffuse gastric cancer genes, methylation analysis.
Samples collected during routine screening endoscopy.
|
Active Comparator: All patients with FOGD
without observation of macroscopic lesions paired with cases (age and sex)
|
Next generation sequencing of a panel of diffuse gastric cancer genes, methylation analysis.
Samples collected during routine screening endoscopy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of subjects in whom somatic mutations or methylation profiles are detected.
Time Frame: Over two years of surveillance
|
Over two years of surveillance
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Replicability of observations over successive endoscopies. Correlation between blood and gastric fluid.
Time Frame: Over two years of surveillance
|
Over two years of surveillance
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 26, 2020
Primary Completion (Estimated)
November 26, 2024
Study Completion (Estimated)
November 26, 2024
Study Registration Dates
First Submitted
January 31, 2020
First Submitted That Met QC Criteria
January 31, 2020
First Posted (Actual)
February 5, 2020
Study Record Updates
Last Update Posted (Estimated)
January 11, 2024
Last Update Submitted That Met QC Criteria
January 10, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP190483
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data entry and management under the responsibility of Dr Patrick Benusiglio investigator coordinating the study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hereditary Diffuse Gastric Cancer
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University of CambridgeCompletedHereditary Diffuse Gastric CancerUnited Kingdom
-
National Cancer Institute (NCI)RecruitingStomach Neoplasms | Stomach Cancer | Gastric Adenocarcinoma and Proximal Polyposis of the Stomach (GAPPS) | Hereditary Diffuse Gastric Cancer (HDGC) | Familial Diffuse Gastric CancerUnited States
-
National Cancer Institute (NCI)CompletedGastric Cancer | Gastric NeoplasmsUnited States
-
Taiho Oncology, Inc.TerminatedMetastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal JunctionBelgium, Spain, United States, Italy, Estonia, Russian Federation, Bulgaria, Hungary, Croatia, Israel, Mexico, Poland, Portugal, Romania, South Africa, Ukraine, United Kingdom, Brazil, Germany, Argentina
-
University of PittsburghCompletedLynch Syndrome | Hereditary Diffuse Gastric Cancer | FAP | Peutz-Jeghers Syndrome | Juvenile Polyposis SyndromeUnited States
-
Region SkaneWithdrawn
-
City of Hope Medical CenterActive, not recruitingAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric Cancer and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
-
National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
-
National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
Clinical Trials on Liquid biopsies (blood, gastric fluid).
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The Netherlands Cancer InstituteMerck Sharp & Dohme LLC; Roche Pharma AG; AstraZenecaUnknown
-
Assistance Publique - Hôpitaux de ParisRecruitingEndometriosis | AdenomyosisFrance
-
Karolinska University HospitalKarolinska InstitutetCompletedAtherosclerosis | Type2 DiabetesSweden
-
Chinese University of Hong KongRecruitingGastric Cancer | Intestinal Metaplasia | Atrophic GastritisHong Kong, Japan, Singapore, Thailand
-
The Institute of Molecular and Translational Medicine...University Hospital Olomouc; Cancer Research Czech RepublicRecruitingCervical Cancer | Oropharyngeal Cancer | Human Papillomavirus Infection | Cervical DysplasiaCzechia
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Mansoura UniversityUnknownHelicobacter Pylori | Gastric Antrum | CORPUS BIOPSIESEgypt
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Fondation Ophtalmologique Adolphe de RothschildTerminated
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Erasmus Medical CenterUnknownCarcinoma, Pancreatic DuctalNetherlands
-
University of LatviaDigestive Diseases Centre GASTRO; Riga East Clinical University Hospital; Academic...RecruitingGastric Cancer | Gastric Intestinal Metaplasia | Gastric Atrophy | Gastric DysplasiaLatvia
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Medical University of ViennaWithdrawnProstate CancerAustria