Prospective Monocentric Clinical-biological Database

NCT04136132 | Recruiting

• 1 other identifier: PROICM 2018-10 BPA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic adenocarcinoma (PA) is a solid cancer with a very poor prognosis with overall survival, all stages combined, not exceeding 5% at 5 years. The incidence and number of deaths caused by this type of tumor have been steadily increasing for two decades. In the absence of therapeutic advances, PA will be one of the leading causes of cancer deaths in 2030. In recent years, researchers and clinicians have now attempted to characterize and understand PA as a whole, through the various stages of its carcinogenesis and the analysis of its microenvironment. Indeed, the stroma of PA can represent up to 80% of the tumor mass and mainly composed of activated fibroblasts (CAF), endothelial and immune cells and extracellular matrix (collagen and fibronectin). However, the characterization of cell subtypes of this stroma is under study, as the pro or anti-tumor role of each cell subtype is not yet well understood. New technologies such as the CyTOF that has just been acquired by the ICM and the IRCM will make it possible to study these problems and to examine the cellular subpopulations that make up the tumor. On the other hand, active research is conducted to disrupt the dialogue between the tumor cells and those of the microenvironment. The search for innovative treatments in pancreatic adenocarcinoma requires the use of models of relevant preclinical studies. The most widely used models are based on cell lines of human origin used in vitro or in vivo after xenograft in immunodeficient mice. In particular, studies with pancreatic adenocarcinomas (PDX) derived tumors of patients reported that the response rate of PDX to certain drugs (gemcitabine, erlotinib ...) used clinically was similar to the response rates of patients enrolled in clinical studies. of these agents as monotherapy. A number of studies have evaluated the efficacy of targeted anti-tumor, anti-angiogenic or anti-stroma therapies from these PDTX models. Personalized medicine strategies can be envisioned as well as the study of new biomarkers, drugs or molecular mechanisms involved in therapeutic resistance. For several years, the investigators have been developing AP PTDX in the INSERM 1194 unit. The investigators propose to continue the development of this collection of pancreatic adenocarcinoma PDTX prospectively and to carry out their histological, molecular and mutational characterization.

Conditions

Pancreatic Cancer

Keywords

oncology; Pancreatic

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who gave their consent to participate in the study

  The proportion of patients who consent to participate in the study among the screened patients

  Until the study completion: 8 years

Study Arms (1)

Biological collection

EXPERIMENTAL

Biological collection For all the patients include in the study : blood and tissue samples collected before and during treatment. In parallel to this biological collection, standardized clinical data will be entered into a database

Other: Biological collection

Interventions

Biological collection OTHER

The biological collection will also include samples of blood samples collected before or after surgery but also samples frozen and/or paraffin-embedded tissue sections.

Biological collection

Eligibility Criteria

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

You may qualify if:

• Patient over the age of 18;
• Patient managed for pancreatic adenocarcinoma;
• Patient eligible for at least one (or more) surgery (s) and chemotherapy;
• Patient giving informed consent

You may not qualify if:

• Patient not affiliated to a social security scheme;
• Pregnant and / or nursing patient;
• Patient under guardianship, curatorship or safeguard of justice;
• Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institut Régional du Cancer de Montpellier

Montpellier, Occ, 34298, France

RECRUITING

Related Publications (6)

• Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 2014 Jun 1;74(11):2913-21. doi: 10.1158/0008-5472.CAN-14-0155.

  PMID: 24840647 BACKGROUND

• Garrido-Laguna I, Hidalgo M. Pancreatic cancer: from state-of-the-art treatments to promising novel therapies. Nat Rev Clin Oncol. 2015 Jun;12(6):319-34. doi: 10.1038/nrclinonc.2015.53. Epub 2015 Mar 31.

  PMID: 25824606 BACKGROUND

• Chiorean EG, Coveler AL. Pancreatic cancer: optimizing treatment options, new, and emerging targeted therapies. Drug Des Devel Ther. 2015 Jul 7;9:3529-45. doi: 10.2147/DDDT.S60328. eCollection 2015.

  PMID: 26185420 BACKGROUND

• Rubio-Viqueira B, Jimeno A, Cusatis G, Zhang X, Iacobuzio-Donahue C, Karikari C, Shi C, Danenberg K, Danenberg PV, Kuramochi H, Tanaka K, Singh S, Salimi-Moosavi H, Bouraoud N, Amador ML, Altiok S, Kulesza P, Yeo C, Messersmith W, Eshleman J, Hruban RH, Maitra A, Hidalgo M. An in vivo platform for translational drug development in pancreatic cancer. Clin Cancer Res. 2006 Aug 1;12(15):4652-61. doi: 10.1158/1078-0432.CCR-06-0113.

  PMID: 16899615 BACKGROUND

• Leconet W, Larbouret C, Chardes T, Thomas G, Neiveyans M, Busson M, Jarlier M, Radosevic-Robin N, Pugniere M, Bernex F, Penault-Llorca F, Pasquet JM, Pelegrin A, Robert B. Preclinical validation of AXL receptor as a target for antibody-based pancreatic cancer immunotherapy. Oncogene. 2014 Nov 20;33(47):5405-14. doi: 10.1038/onc.2013.487. Epub 2013 Nov 18.

  PMID: 24240689 BACKGROUND

• Ogier C, Colombo PE, Bousquet C, Canterel-Thouennon L, Sicard P, Garambois V, Thomas G, Gaborit N, Jarlier M, Pirot N, Pugniere M, Vie N, Gongora C, Martineau P, Robert B, Pelegrin A, Chardes T, Larbouret C. Targeting the NRG1/HER3 pathway in tumor cells and cancer-associated fibroblasts with an anti-neuregulin 1 antibody inhibits tumor growth in pre-clinical models of pancreatic cancer. Cancer Lett. 2018 Sep 28;432:227-236. doi: 10.1016/j.canlet.2018.06.023. Epub 2018 Jun 20.

  PMID: 29935372 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Pierre-Emmanuel COLOMBO, MD

  Institut Régional du Cancer de Montpellier (ICM)

  STUDY CHAIR

Central Study Contacts

Aurore MOUSSION

CONTACT

0467613102; DRCI-icm105@icm.unicancer.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: October 21, 2019
• First Posted: October 23, 2019
• Study Start: May 15, 2019
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2034
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)