Liquid Biopsies for the Personalized Management of Patients with Hereditary Diffuse Gastric Cancer
LISA-HDGC
Liquid Biopsies (blood, Gastric Fluid) for the Personalized Management of Patients with Hereditary Diffuse Gastric Cancer: a Pilot Project
1 other identifier
interventional
16
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
November 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2024
CompletedSeptember 23, 2024
September 1, 2024
3.4 years
January 31, 2020
September 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects in whom somatic mutations or methylation profiles are detected.
Over two years of surveillance
Secondary Outcomes (1)
Replicability of observations over successive endoscopies. Correlation between blood and gastric fluid.
Over two years of surveillance
Study Arms (2)
Unaffected carriers of constitutional mutations
EXPERIMENTALPatients with CDH1 or CTNNA1 germline pathogenic variant. No history of diffuse gastric cancer.
All patients with FOGD
ACTIVE COMPARATORwithout observation of macroscopic lesions paired with cases (age and sex)
Interventions
Next generation sequencing of a panel of diffuse gastric cancer genes, methylation analysis. Samples collected during routine screening endoscopy.
Eligibility Criteria
You may qualify if:
- 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 ≥ 18 years old
- Patients with no oncological history
- Patients with macroscopically normal oeso-gastroduodenal fibroscopy
- French social security.
- Ability to understand and willingness to sign a written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopital Pitié Salpetrière
Paris, Paris, 75013, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2020
First Posted
February 5, 2020
Study Start
November 26, 2020
Primary Completion
April 10, 2024
Study Completion
April 10, 2024
Last Updated
September 23, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor.
- Access Criteria
- Researchers who provide a methodologically sound proposal.
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. Consultation 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.