Actively Recruiting

Phase Not Applicable
All Genders
NCT01774409

Program to Establish the Genetic and Immunologic Profile of Patient's Tumor for All Types of Advanced Cancer

Led by Centre Leon Berard · Updated on 2024-03-04

10000

Participants Needed

6

Research Sites

699 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

It is a non-randomized, multicentric, cohort study, combined with a biological sample collection, a clinical data collection and with a genetic and immunologic biomarkers study. The ProfiLER program aims to implement a personalized cancer medicine approach by proposing to establish the genetic and immunologic profile of the tumor for patients with an advanced malignant tumor, in order to define a map of genetic (for the pre-identified target genes) and immunologic profiles for all the studied types of cancer. This study will also allow adapting the therapeutic management of these patients, if needed, by giving them targeted therapies or immunotherapies (commercialized on in ongoing clinical trials), based on the recommendations of the multidisciplinary molecular board. The genetic and immunologic profile of the tumor will be determined from archival or fresh collected (biopsy of a reachable lesion) tumor sample and from a blood sample. The correlation between genetic profiles of the tumor, patients immunity status and clinical data (progression, tumor response, etc.) collected from the patient medical records will probably allow us to identify biomarkers with a potential predictive value and to determine if some genetic disorders are linked to immunity status alterations.

CONDITIONS

Official Title

Program to Establish the Genetic and Immunologic Profile of Patient's Tumor for All Types of Advanced Cancer

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed diagnosis of advanced (locally-advanced or metastatic) malignant tumor of any histological type
  • Availability of a tumor sample to determine the genetic profile, either archival (formalin fixed and paraffin embedded) or a new biopsy from an accessible lesion
  • Tumor lesion for biopsy must be at least 20 mm in diameter, visible by imaging, and accessible for repeatable needle biopsy without major risk
  • Patients receiving 1st, 2nd, or 3rd line therapy for advanced or metastatic cancer (endocrine monotherapy not considered a line therapy)
  • For patients over 70 years old, a performance status of 0 on the ECOG scale is required
  • Patient must have medical insurance coverage
  • Signed informed consent by the patient or legal representative for those under 18 years old
Not Eligible

You will not qualify if you...

  • No available tumor sample for genetic profiling

AI-Screening

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Trial Site Locations

Total: 6 locations

1

Centre Hospitalier Annecy Genevois

Annecy, France, 74370

Actively Recruiting

2

Groupement Hospitalier Mutualiste

Grenoble, France, 38028

Actively Recruiting

3

Hôpital Edouard Herriot

Lyon, France, 69003

Not Yet Recruiting

4

Centre Léon Bérard

Lyon, France, 69008

Actively Recruiting

5

Centre Hospitalier Lyon Sud

Pierre-Bénite, France, 69495

Active, Not Recruiting

6

CHU de Saint-Etienne Hôpital Nord

Saint-Etienne, France, 42055

Actively Recruiting

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Research Team

J

Jean-Yves BLAY, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Program to Establish the Genetic and Immunologic Profile of Patient's Tumor for All Types of Advanced Cancer | DecenTrialz