NCT04436679

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

February 2, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2025

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

4.1 years

First QC Date

June 15, 2020

Last Update Submit

March 25, 2025

Conditions

Keywords

survivalprognosistissuepancreas cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Relationship between newly described histological markers for pancreatic adenocarcinoma and patient survival.

    at 2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pancreatic adenocarcinoma patients operated on between 2001 and 2016.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

tissues paraffin lumbered paraffin blocks of tissue-microarrays

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Emmanuelle Leteurtre, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 18, 2020

Study Start

February 2, 2021

Primary Completion

February 22, 2025

Study Completion

February 22, 2025

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations