Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04774367
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-03-03
First Post:
2021-02-24
Brief Title:
Evaluation of the Reliability of the Determination of MisMatch Repair Deficiency Status by Endoscopic Biopsies in Oesophagus and Gastric Adenocarcinoma
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Evaluation of the Reliability of the Determination of MisMatch Repair Deficiency Status by Endoscopic Biopsies in Oesophagus and Gastric Adenocarcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOPSYGAST MMR
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 6000 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None