- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05234450
Multi-omics Characterization of Pancreatic Neuroendocrine Tumors and Carcinomas (Camune)
January 31, 2022 updated by: University Hospital, Strasbourg, France
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gabriel MALOUF, MD, PhD
- Phone Number: 33 3 88 11 51 41
- Email: malouf.gabriel@chru-strasbourg.fr
Study Locations
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-
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Strasbourg, France, 67091
- Recruiting
- Service d'Oncologie - CHU de Strasbourg - France
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Principal Investigator:
- Gabriel MALOUF, MD, PhD
-
Contact:
- Gabriel MALOUF, MD, PhD
- Phone Number: 33 3 88 11 51 41
- Email: malouf.gabriel@chru-strasbourg.fr
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Sub-Investigator:
- Véronique DEBIEN, MD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patient (≥18 years old) with histologically confirmed tumor or neuroendocrine carcinoma of the pancreas
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Establishment of the number of tumor subgroups by integrating data from all multi-omics analyses
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gabriel MALOUF, MD, PhD, Service d'Oncologie - CHU de Strasbourg - France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2021
Primary Completion (Anticipated)
June 1, 2022
Study Completion (Anticipated)
June 30, 2022
Study Registration Dates
First Submitted
January 31, 2022
First Submitted That Met QC Criteria
January 31, 2022
First Posted (Actual)
February 10, 2022
Study Record Updates
Last Update Posted (Actual)
February 10, 2022
Last Update Submitted That Met QC Criteria
January 31, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Pancreatic Diseases
- Carcinoma
- Pancreatic Neoplasms
- Neuroendocrine Tumors
Other Study ID Numbers
- 7561
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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