Multi-omics Characterization of Pancreatic Neuroendocrine... | NCT05234450

Studies
Multi-omics Characterization of Pancreatic Neuroendocrine Tumors and Carcinomas

NCT05234450

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Feb 10, 2022Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Cancer of Pancreas

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Actual

Primary Completion Date

Jun 2022Estimated

Completion Date

Jun 30, 2022Estimated

First Submitted Date

Jan 31, 2022

First Submission Date that Met QC Criteria

Jan 31, 2022

First Posted Date

Feb 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2022

Last Update Posted Date

Feb 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Measure	Description	Time Frame
Establishment of the number of tumor subgroups by integrating data from all multi-omics analyses		1 month

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patient (≥18 years old) with histologically confirmed tumor or neuroendocrine carcinoma of the pancreas

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gabriel MALOUF, MD, PhD	Contact	33 3 88 11 51 41		malouf.gabriel@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR	Contact			said.chayer@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Gabriel MALOUF, MD, PhD	Service d'Oncologie - CHU de Strasbourg - France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Oncologie - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms
D018358	Neuroendocrine Tumors
D002277	Carcinoma

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

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Browse Branches

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