Actively Recruiting
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
Eligibility Criteria
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
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
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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