NCT04374175

Brief Summary

This study is about pancreatic cancer. If the diagnostic cancer is done at an early stage (\<2cm), the chances of recovery are very good. But the main problem is there is not any detections means for this cancer. Sadly, when there is a cancer diagnostic , it's already too late in the majority of cases, because the cancer is in an advanced case. Today, there is no any effective means of detection... Blood markers can be a simple means of early detection

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Start

First participant enrolled

April 1, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

5.8 years

First QC Date

April 28, 2020

Last Update Submit

March 17, 2025

Conditions

Adenocarcinoma

Keywords

AdenocarcinomaPancreatic cancerAdiponectinBlood sample

Outcome Measures

Primary Outcomes (1)

  • Serum adiponectin concentration

    Measure by blood sample result Serum adiponectin concentration threshold for which the specificity will be 100% for the diagnosis of pancreatic cancer with a sensitivity of 80%.

    Months : 0

Secondary Outcomes (5)

  • Serum CA19.9 concentration

    Months : 0, 3, 6, 9, 12

  • Tumor response and progression rates according to RECIST v1.1

    Month 12

  • Progression-free survival

    Months : 24

  • Overall survival

    Months : 24

  • Serum adiponectin concentration

    Months : 3, 6, 9, 12

Study Arms (2)

Adenocarcinoma group

Patients with Adenocarcinoma will be included. They will have blood sample at the inclusion visit and at 3 months, 6 months, 9 months and 12 months after.

Biological: Blood sample

Control group

Patient with no adenocarcinoma will be included. They will have blood sample at the inclusion visit.

Biological: Blood sample

Interventions

Blood sampleBIOLOGICAL

Blood sample will be performed

Adenocarcinoma groupControl group

Eligibility Criteria

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

There are 2 groups: patients with adenocarcinoma (ADENOCARCINOMA GROUP) and without (CONTROL GROUP)

You may qualify if:

  • At the start of treatment (before surgery / 1st course of chemotherapy)
  • Age ≥ 18 years
  • Patient affiliated or entitled to a social security system

You may not qualify if:

  • Patient refusal
  • Acute renal failure
  • Child-Pugh B or C cirrhosis
  • Patient under guardianship or curators
  • Other synchronous cancer or history of cancer \<5 years
  • Language barrier
  • CONTROL GROUP
  • Age ≥ 40 years
  • Patient affiliated or entitled to a social security system
  • Digestive endoscopy for any reason other than cancer or chronic inflammatory bowel disease
  • Patient refusal
  • Acute renal failure
  • Child-Pugh B or C cirrhosis
  • Patient under guardianship or curators
  • Other synchronous cancer or history of cancer \<5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Saint-Etienne

Saint-Etienne, France

RECRUITING

Institut Cancérologique Lucien Newirth (ICLN)

Saint-Priest-en-Jarez, 42270, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

AdenocarcinomaPancreatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Nicolas WILLIET, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas WILLIET, MD

CONTACT

(0)477829029nicolas.williet@chu-st-etienne.fr

Jean-Marc PHELIP, MD-PhD

CONTACT

( 0)477828320j.marc.phelip@chu-st-etienne.fr

Study Design

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

Study Record Dates

First Submitted

April 28, 2020

First Posted

May 5, 2020

Study Start

April 1, 2020

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)