Identification of Biomarkers Associated With the Presence of Malignant Pancreatic Lesions Compared to Benign Lesions.

NCT06397846 | Recruiting

• 1 other identifier: 2023/842
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The challenge for medical oncology is to develop plasma biomarkers that can detect the influence of the stroma on diagnosis, prognosis and response to chemotherapy. Today, there is no validated blood test to help diagnose pancreatic cancer (PDAC). The search for blood biomarkers of the tumor stroma and immunological markers is therefore a major challenge in orienting the diagnosis towards PDAC and optimizing the therapeutic management of pancreatic cancers. The aim of the study is to identify biomarkers associated with the presence of malignant pancreatic lesions (patients from the Pancreas-CGE cohort, a cohort already set up by our team) compared with benign lesions (patients followed up for benign pancreatic lesions). Candidate biomarkers from our preliminary work will be considered initially. Other biomarkers may be explored secondarily. The ultimate goal is to develop a clinico-biological signature that is as efficient as possible in predicting the presence of malignant pancreatic lesions compared with benign ones.

Conditions

Benign Pancreatic Lesion

Outcome Measures

Primary Outcomes (1)

• the malignant versus benign nature of the pancreatic lesion, based on radiological, echo-endoscopic and/or anatomopathological characteristics.

  one visit at baseline

Study Arms (1)

Biological sample

EXPERIMENTAL

Blood sample

Other: Biological sample

Interventions

Biological sample OTHER

blood sample will be collected at baseline

Biological sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥18 years
• Patient followed for benign pancreatic lesions:
• chronic pancreatitis acute pancreatitis at a distance from the acute episode (\> 4 weeks) with indication for echo-endoscopy for suspected precancerous pancreatic lesions (PanIN, TIPMP, mucinous cystadenomas) or other cystic lesions (serous cystadenomas)

You may not qualify if:

• Malignant pancreatic tumor
• Legal incapacity or limited legal capacity

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (2)

University Hospital of Besancon

Besançon, France

RECRUITING

Hôpital Nord Franche-Comté

Montbéliard, France

RECRUITING

Central Study Contacts

Angélique VIENOT, Dr

CONTACT

+3381479999; a3vienot@chu-besancon.fr

Marion JACQUIN

CONTACT

m1jacquin@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: December 11, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

FR (2)