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

About this trial
This is an interventional other trial for Gastro-oesophageal Adenocarcinoma
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
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
NCT ID
NCT04774367
First Posted
February 24, 2021
Last Updated
March 1, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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
Evaluation of the Reliability of the Determination of MisMatch Repair Deficiency Status by Endoscopic Biopsies in Oesophagus and Gastric Adenocarcinoma.
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