NCT05234450

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

January 31, 2022

Last Update Submit

January 31, 2022

Conditions

Keywords

Cancer of PancreasNeuroendocrine TumorsCarcinomaNeuroendocrine

Outcome Measures

Primary Outcomes (1)

  • Establishment of the number of tumor subgroups by integrating data from all multi-omics analyses

    1 month

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Opposition of the patient to participate in the study
  • Diagnosis other than pancreatic neuroendocrine tumor
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Oncologie - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsNeuroendocrine TumorsCarcinoma

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNeoplasms, Glandular and Epithelial

Study Officials

  • Gabriel MALOUF, MD, PhD

    Service d'Oncologie - CHU de Strasbourg - France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saïd CHAYER, PhD, HDR

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 10, 2022

Study Start

December 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 30, 2022

Last Updated

February 10, 2022

Record last verified: 2022-01

Locations