SERum-bank for PANcreatic Cancer (SERPAN)

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

Study Overview

• Status: Recruiting
• Conditions: Adenocarcinoma
• Intervention / Treatment: Biological: Blood sample

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Nicolas WILLIET, MD; Phone Number: +33 (0)477829029; Email: nicolas.williet@chu-st-etienne.fr
• Study Contact Backup: Name: Jean-Marc PHELIP, MD-PhD; Phone Number: +33 ( 0)477828320; Email: j.marc.phelip@chu-st-etienne.fr

Study Locations

• France
  • Saint-Priest-en-Jarez, France, 42270
    • Recruiting
    • Institut Cancérologique Lucien Newirth (ICLN)
    • Principal Investigator: Lea SABAN-ROCHE, MD
  • Saint-Étienne, France
    • Recruiting
    • CHU SAINT-ETIENNE
    • Principal Investigator: Nicolas WILLIET, MD
    • Sub-Investigator: Jean-Marc PHELIP, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Nicolas WILLIET, MD, CHU SAINT-ETIENNE

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Adenocarcinoma; Pancreatic cancer; Blood sample; Adiponectin
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Adenocarcinoma; Pancreatic Neoplasms
• Other Study ID Numbers: 20CH035; 2020-A00393-36 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No