Clinical trial NCT01774409: Program to Establish the Genetic and Immunologic Profile of Patient's Tumor for All Types of Advanced Cancer
Official title: Program to Establish the Genetic and Immunologic Profile of Patient's Tumor for All Types of Advanced Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Keywords: all advanced malignant tumor
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2013-01-24
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: Determination of the tumor profile and review in multidisciplinary molecular board:

The genetic and immunologic profile will be performed from the available tumor sample and from a blood sample.

Genetic profile:

* Research of mutations/insertions/deletions for an array of predefined genes in tumor deoxyribonucleic acid by high-throughput sequencing
* Analysis of copy number variations of genes on tumor deoxyribonucleic acid by microarray-based comparative genomic hybridization
* Analysis of rearrangements involving the gene Anaplastic Lymphoma Kinase that can't be detected by Next Generation Sequencing or array Comparative Genomic Hybridization (balanced translocations) by means of fluorescent hybridization probes on tumor samples Immunologic profile: analysis of the expression of relevant immunologic markers

Clinical data collection:

Patients' clinical data will be collected from the patient medical record. This study is not a treatment evaluation. Patients' follow-up and treatment will be performed according to the center local practices or to the specificities of a clinical trial in which the patient would have been enrolled, depending on the recommendations given by the multidisciplinary molecular board, with the review of the tumor genetic profile.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced (locally-advanced or metastatic) malignant tumor of any histological type
* Tumor sample available to determine the genetic profile: either archival tumor sample \[FFPE (formalin fixed and paraffin embedded)\] or perform a new biopsy on an accessible lesion (left at the investigator's appreciation). For biopsies, presence of at least one tumor lesion with a diameter ≥ 20 mm, visible by medical imaging and accessible to repeatable percutaneous (needle biopsies 18 gauge or larger) sampling that permit core needle biopsy (ideally 4 cores) without unacceptable risk of a major procedural complication. Please note that brain and bone lesions are not considered as accessible lesions.
* Patient with 1st, 2nd or 3rd line therapy (NB: endocrine therapy (monotherapy) are not considered as line therapy) for advanced / metastatic cancer.
* For patients over 70 years of age, a Performance Status (PS) of 0 on the ECOG scale.
* Patient must be covered by a medical insurance.
* Informed consent signed by the patient and/or by parents (or legal representative) for patients below 18.

Exclusion Criteria:

* No tumor sample available.

Primary outcomes:
measure: Establish a map of genetic profiles (for the pre-identified target genes) for all types of advanced malignant tumors.
timeFrame: at least 3 years after patient enrollment
Secondary outcomes:
measure: Establish a map of immunologic profiles for all types of advanced malignant tumors.
timeFrame: at least 3 years after patient enrollment
measure: Determine for each histological type of tumor, characteristic profiles of genetic and/or immunologic disorders and disorders that might be common to several histological types.
timeFrame: at least 3 years after patient enrollment
measure: Identify genetic and/or immunologic biomarkers (or molecular profiles) with a potential predictive value on response to treatments.
timeFrame: at least 3 years after patient enrollment
measure: Identify biomarkers (constitutional or somatic alterations in tumor cells) that might be correlated with systemic or local alterations of the immunity status observed in some patients with advanced cancers
timeFrame: at least 3 years after patient enrollment
measure: Assess the changes of genetic and/or immunologic profiles in case of progressive disease
timeFrame: at least 3 years after patient enrollment
measure: Number of patients with a recommanded therapy based on their molecular profil and/or for whom the therapy hs been administrated and description of the recommanded therapy
timeFrame: at least 3 years after patient enrollment
measure: Describe the clinical impact of this molecular profiling in term of PFS
timeFrame: at least 3 years after patient enrollment
measure: Describe the clinical impact of this molecular profiling in term of OS
timeFrame: at least 3 years after patient enrollment
measure: Describe the clinical impact of this molecular profiling in term of tumor response
timeFrame: at least 3 years after patient enrollment
Other outcomes:
Locations:
city: Annecy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Grenoble
country: France
facility: Groupement Hospitalier Mutualiste
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Lyon
country: France
facility: Centre Léon Bérard
city: Pierre-Bénite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Saint-Etienne
country: France
facility: CHU de Saint-Etienne Hôpital Nord
Study officials:
affiliation: Centre Leon Berard
name: Jean-Yves BLAY, MD PhD
role: PRINCIPAL_INVESTIGATOR
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