New Biomarkers in Pancreatic Cancer Using EXPEL Concept

NCT03791073 | Unknown

• 1 other identifier: RECHMPL18_0437
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators recently engineered a novel biomarker discovery approach that is non-destructive and fully compatible with OMICS profiling as well as routine clinical procedures (5). The latter approach - termed EXPEL - mines the interstitial tissue fluid that is the richest source of soluble, undiluted and uncontaminated biomarkers. The method notably gives access to proteins, metabolites, RNA, DNA and exosomes, thus enabling holistic biomarker discovery. Owing to its non-destructive nature, EXPEL provides for the first time both clinicians and researchers with the opportunity to analyze identical material. The investigators hypothesize that the conservation liquid used to collect cells and biopsy after endoscopic ultrasound for pancreatic biopsy could contain the tissue secretome and permit a comprehensive OMICS analysis of PDAC (all stages confounded) by using a "modified EXPEL" procedure. These are ideal conditions for EXPEL approach that will additionally to finding novel biomarkers also shed light on complex network of cancer cell-stroma interactions.

Conditions

Oncology

Keywords

Biomarker discovery; Pancreatic adenocarcinoma; Bioinformatics; pancreatic cancer; microenvironment; proteomics; transcriptomics; metabolomics; diagnosis; Prognosis

Outcome Measures

Primary Outcomes (1)

• Predictive value of each protein contained in Cytolyt® for the positive diagnosis of pancreatic ductal adenocarcinoma

  Correlation with positive diagnosis of pancreatic ductal adenocarcinoma and proteins quantity in Cytolyt® samples using ROC curves (sensibility/specificity: Area Under the Curve \> 0.85) and binary logistic regression method with controlling for the effects of the co-variates (such as age, disease cTNM stage, and treatment details).

  an average of 1 year

Secondary Outcomes (5)

• Biomarkers that are prognostically significant on disease free or overall survival in patients with pancreatic cancer, identified using the survival analysis

  1 year

• Biomarkers that are prognostically significant on disease free or overall survival in patients with pancreatic cancer, identified using the survival analysis

  1 year

• Biomarkers that are prognostically significant on disease free or overall survival in patients with pancreatic cancer, identified using the survival analysis

  1 year

• Biomarkers that are prognostically significant on disease free or overall survival in patients with pancreatic cancer, identified using the survival analysis

  1 year

• Biomarkers that are prognostically significant on disease free or overall survival in patients with pancreatic cancer, identified using the survival analysis

  1 year

Eligibility Criteria

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

Study Population

Patient with pancreatic mass and suspicion of pancreatic ductal adenocarcinoma requiring endoscopic ultrasound with fine needle biopsy or surgery

You may qualify if:

• Patient with pancreatic mass and suspicion of pancreatic ductal adenocarcinoma requiring endoscopic ultrasound with fine needle biopsy or surgery
• Patient ≥18 years old
• Patient naïve of any treatment of Pancreatic cancer

You may not qualify if:

• Patient who reject the study protocol

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• IRCM U1194 INSERM, Tumor Microenvironment and Resistance to Treatment Lab: collaborator
• IRCM U1194 INSERM, Cancer Bioinformatics and Systems Biology's team: collaborator

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

Related Publications (1)

• Souche R, Tosato G, Riviere B, Valats JC, Debourdeau A, Flori N, Pourquier D, Fabre JM, Assenat E, Colinge J, Turtoi A. Detection of soluble biomarkers of pancreatic cancer in endoscopic ultrasound-guided fine-needle aspiration samples. Endoscopy. 2022 May;54(5):503-508. doi: 10.1055/a-1550-2503. Epub 2021 Aug 26.

  PMID: 34448184 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cytolyt Samples: Liquid conservation samples from patients who underwent endoscopic ultrasound with fine needle aspiration/biopsy for suspicious pancreatic mass at the CHU de Montpellier were conserved at +4°c. Cytolyt samples do not contain any cell or tissue from patient, this liquid is systematically trashed in current practice. No genetics analysis will be performed from these particular samples in the present study.

MeSH Terms

Conditions

Neoplasms; Pancreatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• REGIS SOUCHE

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

REGIS SOUCHE, MD

CONTACT

467337072; fr-souche@chu-montpellier.fr

Jean-Michel Fabre, MD, PhD

CONTACT

467337072; jm-fabre@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: January 2, 2019
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: November 1, 2024
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

FR (1)