2020-04-01
2026-01-01
2026-01-01
400
NCT04374175
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
OBSERVATIONAL
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.
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 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
Participant Group/Arm | Intervention/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
|
: Control group Patient with no adenocarcinoma will be included. They will have blood sample at the inclusion visit. | BIOLOGICAL: Blood sample
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
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 Outcome Measures | Measure Description | Time Frame |
---|---|---|
Serum CA19.9 concentration | Measure by blood sample result Threshold for Comparison of diagnostic performance compared to serum adiponectin concentration | Months : 0, 3, 6, 9, 12 |
Tumor response and progression rates according to RECIST v1.1 | Tumor 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 survival | Months : 24 | |
Overall survival | Months : 24 | |
Serum adiponectin concentration | Measure by blood sample result Serum adiponectin concentration to correlate with cancer progression or not. | Months : 3, 6, 9, 12 |
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 |
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:
This is where you will find people and organizations involved with this study.
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