SERum-bank for PANcreatic Cancer

Adenocarcinoma Clinical Trial

— SERPAN  

Official title:

SERum-bank for PANcreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04374175
• Other study ID #: 20CH035
• Secondary ID: 2020-A00393-36
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: January 1, 2026

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Nicolas WILLIET, MD
• Phone: (0)477829029
• Email: nicolas.williet[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Neoplasms

Intervention

Biological:
• Blood sample
Blood sample will be performed

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne
France	Institut Cancérologique Lucien Newirth (ICLN)	Saint-Priest-en-Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Progression-free survival		Months : 24
Secondary	Overall survival		Months : 24
Secondary	Serum adiponectin concentration	Measure by blood sample result Serum adiponectin concentration to correlate with cancer progression or not.	Months : 3, 6, 9, 12