SERum-bank for PANcreatic Cancer

NCT ID: NCT04374175

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2026-01-01

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

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.

Conditions

Adenocarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Blood sample

Intervention Type: BIOLOGICAL

Blood sample will be performed

Control group

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

Blood sample

Intervention Type: BIOLOGICAL

Blood sample will be performed

Interventions

Blood sample

Blood sample will be performed

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• 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
• Language barrier

CONTROL GROUP

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas WILLIET, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

CHU Saint-Etienne

Saint-Etienne, , France

Site Status: RECRUITING

Institut Cancérologique Lucien Newirth (ICLN)

Saint-Priest-en-Jarez, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Nicolas WILLIET, MD

Role: CONTACT

nicolas.williet@chu-st-etienne.fr

(0)477829029 ext. +33

Jean-Marc PHELIP, MD-PhD

Role: CONTACT

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

( 0)477828320 ext. +33

Other Identifiers

2020-A00393-36

Identifier Type: OTHER

Identifier Source: secondary_id

20CH035

Identifier Type: -

Identifier Source: org_study_id