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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04436679
Other study ID # 2019_29
Secondary ID 2019-A02001-56
Status Recruiting
Phase
First received
Last updated
Start date February 2, 2021
Est. completion date February 2025

Study information

Verified date April 2022
Source University Hospital, Lille
Contact Emmanuelle Leteurtre, MD,PhD
Phone 0320445556
Email emmanuelle.leteurtre@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study is particularly innovative as it will accurately analyze the microscopic characteristics of the stroma, tumor budding and mucin expression in adenocarcinomas of the pancreas, using a comparative approach of long-survivor/short-survival patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 144
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients > 18 years of age at diagnosis - Primary pancreatic cancer patients operated on in one of the 4 centres between 2001 and 2016 - Histopathological diagnosis of excreto-pancreatic adenocarcinoma of the pancreas, ductal adenocarcinoma or classical adenocarcinoma - Tissue blocks (FFPE) available (tumour/healthy tissue) - Affiliated to a social security scheme Exclusion Criteria: - Absence of Primary Cancer Tissue Blocks (PCTBs) - Paraffin block fixed in Bouin or AFA - Patient Refusal - Pancreatic cancer not corresponding to a conventional excretopancreatic adenocarcinoma such as: carcinoma on intraductal papillary mucinous neoplasm, endocrine tumor/carcinoma, acinar cell carcinoma, ...). - Patient died due to post-surgical complications (death within 30 days post-surgery). - Surgical resection of macroscopic R2 type.

Study Design


Locations

Country Name City State
France Hop Claude Huriez Chu Lille Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relationship between known prognostic histological markers of pancreatic adenocarcinoma and patient survival. Tissue analysis will be performed by conventional microscopy and will evaluate histological markers known in the literature to have a prognostic impact. at 2 years
Secondary Relationship between newly described histological markers for pancreatic adenocarcinoma and patient survival. Immunohistochemistry tissue analysis. It will allow the evaluation of newly described histological markers for pancreatic adenocarcinoma, which could have a prognostic impact such as the immunophenotype of the inflammatory infiltrate, the expression of the mucins MUC1, MUC5AC, MUC4, MUC16, mesothelin, p53, Ki67 (MIB1) and markers of aggressive subtypes identified by transcriptome studies, in particular the basal-like molecular subtype. at 2 years
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