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SERum-bank for PANcreatic Cancer


2020-04-01


2026-01-01


2026-01-01


400

Study Overview

SERum-bank for PANcreatic Cancer

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

The purpose of this study is to establish a sero-library in a case-control cohort to assess several potentially useful serum biomarkers, such as adiponectin in the early diagnosis of pancreatic cancer.

  • Adenocarcinoma
  • BIOLOGICAL: Blood sample
  • 20CH035
  • 2020-A00393-36 (OTHER Identifier) (OTHER: ANSM)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2020-04-28  

N/A  

2025-03-17  

2020-05-04  

N/A  

2025-03-18  

2020-05-05  

N/A  

2025-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
: 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

  • Blood sample will be performed
: Control group

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

BIOLOGICAL: Blood sample

  • Blood sample will be performed
Primary Outcome MeasuresMeasure DescriptionTime Frame
Serum adiponectin concentrationMeasure 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 Outcome MeasuresMeasure DescriptionTime Frame
Serum CA19.9 concentrationMeasure by blood sample result Threshold for Comparison of diagnostic performance compared to serum adiponectin concentrationMonths : 0, 3, 6, 9, 12
Tumor response and progression rates according to RECIST v1.1Tumor response and progression rates defined according to RECIST v1.1 criteria according to a serum threshold of the prognostic biomarker to be identified by logistic regression analyzes.Month 12
Progression-free survivalMonths : 24
Overall survivalMonths : 24
Serum adiponectin concentrationMeasure by blood sample result Serum adiponectin concentration to correlate with cancer progression or not.Months : 3, 6, 9, 12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Nicolas WILLIET, MD

Phone Number: (0)477829029

Email: nicolas.williet@chu-st-etienne.fr

Study Contact Backup

Name: Jean-Marc PHELIP, MD-PhD

Phone Number: ( 0)477828320

Email: j.marc.phelip@chu-st-etienne.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    ADENOCARCINOMA GROUP
    Inclusion Criteria:

  • Documented adenocarcinoma (cytology / anatomopathology), all stages, except if the tumor is immediately resectable and does not require preoperative cytological evidence. In this case, the inclusion and the first collection of the sero bank is done preoperatively. The diagnostic confirmation will therefore be made post-operatively at the risk of being excluded in the event of a different diagnosis.
  • At the start of treatment (before surgery / 1st course of chemotherapy)
  • Age ≥ 18 years
  • Patient affiliated or entitled to a social security system

  • Exclusion Criteria:

  • 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
    Inclusion Criteria:

  • 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

  • Exclusion Criteria:

  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Nicolas WILLIET, MD, CHU SAINT-ETIENNE

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available