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Evaluation of the Reliability of the Determination of MisMatch Repair Deficiency Status by Endoscopic Biopsies in Oesophagus and Gastric Adenocarcinoma. (BIOPSYGAST MMR)

Primary Purpose

Gastro-oesophageal Adenocarcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps
Order of forceps : First large capacity biopsy forceps and second standard biopsy forceps
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gastro-oesophageal Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Eligible criteria :

  • Patient having endoscopic oesogastroduodenal endoscopy for suspicion of oesogastro-duodenal adenocarcinoma.
  • Benefiting from the social security system

Inclusion Criteria:

  • Patient having endoscopy biopsies in front of a suspicious lesion suggestive of gastroesophageal adenocarcinoma

Exclusion Criteria:

  • Minor patient (<18 years old)
  • known pregnancy
  • Major patient under tutorship or curatorship
  • Contraindication to gastric biopsies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps

    Order of forceps : First large capacity biopsy forceps and second standard biopsy forceps

    Arm Description

    Outcomes

    Primary Outcome Measures

    Sensitivity (Se) of the determination of the dMMR status by the endoscopic biopsies performed at the time of the initial high endoscopy
    The sensitivity will be evaluated by comparing the endocospic result with that obtained by the analysis of the specimen considered as the reference examination.
    Specificity (Spe) of the determination of the dMMR status by the endoscopic biopsies performed at the time of the initial high endoscopy
    The specificity will be evaluated by comparing the endocospic result with that obtained by the analysis of the specimen considered as the reference examination.

    Secondary Outcome Measures

    Positive likelihood ratios
    Negative likelihood ratios
    Sensitivity of dMMR status diagnosis according to the forceps (standard and large capacity biopsy forceps )
    Specificity of dMMR status diagnosis according to the forceps (standard and large capacity biopsy forceps )
    Sensitivity of dMMR status diagnosis according to the techniques (immunohistochemistry and PCR)
    Specificity of dMMR status diagnosis according to the techniques (immunohistochemistry and PCR)
    Sensitivity of the diagnosis of MR status according to the location on the biopsies (esophagus, gastroesophageal junction, fundus, antrum)
    Specificityof the diagnosis of MR status according to the location on the biopsies (esophagus, gastroesophageal junction, fundus, antrum)
    Sensitivity of dMMR status diagnosis according to the number of techniques used (two techniques or one technique)
    Specificity of dMMR status diagnosis according to the number of techniques used (two techniques or one technique)
    Overall survival
    Survival without recurrence

    Full Information

    First Posted
    February 24, 2021
    Last Updated
    March 1, 2021
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04774367
    Brief Title
    Evaluation of the Reliability of the Determination of MisMatch Repair Deficiency Status by Endoscopic Biopsies in Oesophagus and Gastric Adenocarcinoma.
    Acronym
    BIOPSYGAST MMR
    Official Title
    Evaluation of the Reliability of the Determination of MisMatch Repair Deficiency Status by Endoscopic Biopsies in Oesophagus and Gastric Adenocarcinoma.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2021 (Anticipated)
    Primary Completion Date
    March 2023 (Anticipated)
    Study Completion Date
    March 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Gastro-esophageal adenocarcinoma is one of the most common cancer in the world and the fourth most common cancer in France with more than 6,000 cases per year. For non-metastatic patients, a preoperative chemotherapy is recommended. As colorectal adenocarcinomas, gastroesophageal cancers (OGC) could be caused by a failure of DNA repair related to the loss of expression of one of the DNA repair proteins (MLH1, MSH2, PMS2, MSH6) (deficient MMR (dMMR)). The prevalence of tumors with dMMR is evaluated at 14% (Choi et al, 2014; Kim et al, 2015). This proportion reaches 25% among patients over 70 years old. Evidence suggests that patients with dMMR tumors do not benefit from neoadjuvant chemotherapy (Smyth et al, 2017), which may even have a negative impact, especially in elderly patients, and which should be discussed in this particular situation. The decision of neo-adjuvant chemotherapy must be taken very quickly after the endoscopic diagnosis. The investigators will evaluate the diagnostic performance of the determination of dMMR status by endoscopic biopsies of OGC. Moreover, there is no clear recommendation for the determination of dMMR status in OGC especially regarding the size of the forceps to use to ensure the quality of samples and the best molecular techniques for dMMR status determination. Methods In this prospective study, the investigators will include patients who will benefit from an upper endoscopy within 5 French hospital centers (Saint-Louis, Lariboisière, Beaujon, Bichat and Avicenne) linked to the NORDICAP network. If a suspect lesion of OGC is discovered during the gastroscopy, the endoscopist will perform at least 8 endoscopic biopsies, according to the recommendations, and by the mean of 2 kinds of forceps: standard biopsy forceps and a large capacity biopsy forceps. The clinical and follow-up data will be prospectively collected and will include demographics data, cancer stage, lymph node invasion, treatment history, recurrence and survival data. The investigators will assess MSI status by genotyping and MMR proteins expression by immunochemistry (IHC), performed, for each patient, on both biopsies and surgical tumor samples. Expected results This study will allow us to compare diagnostic performance of endoscopic biopsies to surgical samples for the assessment of dMMR status. Likewise, the investigators will compare the diagnostic performance of the two kinds of endoscopic forceps and of IHC and genotyping for the determination of dMMR phenotype. It will enable us to establish recommendations for the benefit of gastro-enterologists and pathologists.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastro-oesophageal Adenocarcinoma

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps
    Arm Type
    Other
    Arm Title
    Order of forceps : First large capacity biopsy forceps and second standard biopsy forceps
    Arm Type
    Other
    Intervention Type
    Device
    Intervention Name(s)
    Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps
    Intervention Description
    Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps
    Intervention Type
    Device
    Intervention Name(s)
    Order of forceps : First large capacity biopsy forceps and second standard biopsy forceps
    Intervention Description
    Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps
    Primary Outcome Measure Information:
    Title
    Sensitivity (Se) of the determination of the dMMR status by the endoscopic biopsies performed at the time of the initial high endoscopy
    Description
    The sensitivity will be evaluated by comparing the endocospic result with that obtained by the analysis of the specimen considered as the reference examination.
    Time Frame
    at inclusion
    Title
    Specificity (Spe) of the determination of the dMMR status by the endoscopic biopsies performed at the time of the initial high endoscopy
    Description
    The specificity will be evaluated by comparing the endocospic result with that obtained by the analysis of the specimen considered as the reference examination.
    Time Frame
    at inclusion
    Secondary Outcome Measure Information:
    Title
    Positive likelihood ratios
    Time Frame
    at inclusion
    Title
    Negative likelihood ratios
    Time Frame
    at inclusion
    Title
    Sensitivity of dMMR status diagnosis according to the forceps (standard and large capacity biopsy forceps )
    Time Frame
    at inclusion
    Title
    Specificity of dMMR status diagnosis according to the forceps (standard and large capacity biopsy forceps )
    Time Frame
    at inclusion
    Title
    Sensitivity of dMMR status diagnosis according to the techniques (immunohistochemistry and PCR)
    Time Frame
    at inclusion
    Title
    Specificity of dMMR status diagnosis according to the techniques (immunohistochemistry and PCR)
    Time Frame
    at inclusion
    Title
    Sensitivity of the diagnosis of MR status according to the location on the biopsies (esophagus, gastroesophageal junction, fundus, antrum)
    Time Frame
    at inclusion
    Title
    Specificityof the diagnosis of MR status according to the location on the biopsies (esophagus, gastroesophageal junction, fundus, antrum)
    Time Frame
    at inclusion
    Title
    Sensitivity of dMMR status diagnosis according to the number of techniques used (two techniques or one technique)
    Time Frame
    at inclusion
    Title
    Specificity of dMMR status diagnosis according to the number of techniques used (two techniques or one technique)
    Time Frame
    at inclusion
    Title
    Overall survival
    Time Frame
    up to 36 months
    Title
    Survival without recurrence
    Time Frame
    up to 36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Eligible criteria : Patient having endoscopic oesogastroduodenal endoscopy for suspicion of oesogastro-duodenal adenocarcinoma. Benefiting from the social security system Inclusion Criteria: Patient having endoscopy biopsies in front of a suspicious lesion suggestive of gastroesophageal adenocarcinoma Exclusion Criteria: Minor patient (<18 years old) known pregnancy Major patient under tutorship or curatorship Contraindication to gastric biopsies
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Thomas APARICIO
    Phone
    +33142499597
    Email
    thomas.aparicio@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Matthieu Resche-Rigon
    Phone
    +33142499742
    Email
    matthieu.resche-rigon@univ-paris-diderot.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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