Actively Recruiting

Age: 18Years +
All Genders
ID05103969

Multicenter Prospective Cohort Study of Tumors With POLE and POLD1 Mutations

Led by Federation Francophone de Cancerologie Digestive · Updated on 2024-07-08

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying tumors that have specific mutations in the POLE or POLD1 genes across all stages and primary sites. The main goal is to identify and describe the clinical, biological, and molecular features of these tumors. This observational study gathers important information to better understand how these mutations affect cancer characteristics and patient outcomes. Patients are identified through tumor genotyping platforms, which detect these POLE or POLD1 mutations. These platforms notify the project coordination team and the lead investigator about new cases. The study collects diagnostic and follow-up data prospectively from patients with these mutations, regardless of tumor stage or site. Participants will have their tumor data entered and monitored over time, including molecular characteristics, overall survival, and response to treatments. The research team will maintain a database and tissue block library for ongoing analysis. The study is expected to continue through October 2027, with data collection and follow-up occurring during this period.

CONDITIONS

Brief Title

Cohort of Tumors With POLE/D1 Mutation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Tumor with a pathogenic variant in the exonuclease domain of POLE (exons 9 to 14) or POLD1 (exons 8 to 12) as classified by the project group
  • Tumor diagnosis made at cohort launch date or within the previous year
  • Participant is 18 years of age or older
Not Eligible

You will not qualify if you...

  • Tumor without POLE or POLD1 mutation
  • Tumor with POLE mutation identified only in retrospective research studies
  • Patient does not consent to data registration in the cohort

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants who undergo routine care are observed. Diagnostic and follow-up data are collected prospectively to characterize tumors with POLE/POLD1 mutations and track overall survival and treatment response.

Periodic visits as part of routine care

Trial Site Locations

Total: 1 location

1

CHU -hopital Rangeuil

Toulouse, France, 31059

Actively Recruiting

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Research Team

R

ROSINE GUIMBAUD, PhD.MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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