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Liquid Biopsies for the Personalized Management of Patients With Hereditary Diffuse Gastric Cancer (LISA-HDGC)

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ClinicalTrials.gov Identifier: NCT04253106
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Hereditary Diffuse Gastric Cancer Genetic: Liquid biopsies (blood, gastric fluid). Not Applicable

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, we will perform liquid biopsies of both blood and gastric fluid in asymptomatic carriers who refuse gastrectomy and in controls. We 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicentric, prospective non-randomized study prognostic aim. Control group planned to have standard values.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Liquid Biopsies (Blood, Gastric Fluid) for the Personalized Management of Patients With Hereditary Diffuse Gastric Cancer: a Pilot Project
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : June 2023


Arm Intervention/treatment
Experimental: Unaffected carriers of constitutional mutations
Patients with CDH1 or CTNNA1 germline pathogenic variant. No history of diffuse gastric cancer.
Genetic: Liquid biopsies (blood, gastric fluid).
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)
Genetic: Liquid biopsies (blood, gastric fluid).
Next generation sequencing of a panel of diffuse gastric cancer genes, methylation analysis. Samples collected during routine screening endoscopy.




Primary Outcome Measures :
  1. Number of subjects in whom somatic mutations or methylation profiles are detected. [ Time Frame: Over two years of surveillance ]

Secondary Outcome Measures :
  1. Replicability of observations over successive endoscopies. Correlation between blood and gastric fluid. [ Time Frame: Over two years of surveillance ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 curatorship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253106


Contacts
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Contact: BENUSIGLIO Patrick, MD PhD 33142177659 patrick.benusiglio@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04253106    
Other Study ID Numbers: APHP190483
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data entry and management under the responsability of Dr Patrick Benusiglio investigator coordinating the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases