Camune: Multi-omics Characterization of Pancreatic Neuroendocrine Tumors and Carcinomas

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05234450
Collaborator
(none)
300
1
6.9
43.3

Study Details

Study Description

Brief Summary

In this work, the investigators count through the integrated multi-omics analysis to identify different tumor subgroups in pancreatic neuroendocrine tumors and carcinomas regardless of their grade and stage. To achieve this, they will resort to the use of next-generation sequencing approaches (RNAseq, then use of MCP Counter for the absolute quantification of the eight populations of immune cells in the tumor microenvironment), alterations in epigenetics with study of the methylome by MeDIP, ChIPseq, telomere (ALT) study, as well as correlation with peripheral blood neutrophil to lymphocyte ratio and immunohistochemistry data such as Ki67, p53, Rb, DAXX, ATRX, PDL1, immune cell labeling. This will be done on frozen or paraffin material. This work will provide a more complete biological picture of pancreatic neuroendocrine tumors and carcinomas.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Multi-omics Characterization of Pancreatic Neuroendocrine Tumors and Carcinomas
    Actual Study Start Date :
    Dec 1, 2021
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Jun 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Establishment of the number of tumor subgroups by integrating data from all multi-omics analyses [1 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion criteria:
    • Adult patient (≥18 years old)

    • Subject with histologically confirmed tumor or neuroendocrine carcinoma of the pancreas

    • Subject with tumors or neuroendocrine carcinoma of the pancreas regardless of the stage of the disease

    • Supported at the University Hospitals of Strasbourg between 01/01/2008 and 01/09/2019

    • Near therapeutic blood count available (less than 6 months)

    • Availability of frozen and/or paraffin tumor material

    • Patients who have already given their consent for their biological resources to be kept at the CRB or in the anatomopathology department of the HUS, and subsequently reused, as well as the anonymous data associated with them, for scientific research purposes.

    Exclusion criteria:
    • Opposition of the patient to participate in the study

    • Diagnosis other than pancreatic neuroendocrine tumor

    • Biological tissue from a patient who does not meet all the inclusion criteria

    • Impossibility of giving informed information to the subject

    • Patient under judicial protection En savoir plus sur ce texte sourceVous devez indiquer le texte source pour obtenir des informations supplémentaires Envoyer des commentaires Panneaux latéraux

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service d'Oncologie - CHU de Strasbourg - France Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Principal Investigator: Gabriel MALOUF, MD, PhD, Service d'Oncologie - CHU de Strasbourg - France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05234450
    Other Study ID Numbers:
    • 7561
    First Posted:
    Feb 10, 2022
    Last Update Posted:
    Feb 10, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 10, 2022