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

NCT01774409 | Recruiting

• 2 other identifiers: PROFILERET12-082
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 6

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.

Conditions

Neoplasms

Keywords

all advanced malignant tumor

Outcome Measures

Primary Outcomes (1)

• Establish a map of genetic profiles (for the pre-identified target genes) for all types of advanced malignant tumors.

  Description of the incidence rates of each detected genetic disorder among the pre-identified target genes in the global cohort and for each histological type.

  at least 3 years after patient enrollment

Secondary Outcomes (9)

• Establish a map of immunologic profiles for all types of advanced malignant tumors.

  at least 3 years after patient enrollment

• 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.

  at least 3 years after patient enrollment

• Identify genetic and/or immunologic biomarkers (or molecular profiles) with a potential predictive value on response to treatments.

  at least 3 years after patient enrollment

• 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

  at least 3 years after patient enrollment

• Assess the changes of genetic and/or immunologic profiles in case of progressive disease

  at least 3 years after patient enrollment

Study Arms (1)

Blood and tumor samples

EXPERIMENTAL

Genetic: Blood and tumor samples

Interventions

Blood and tumor samples GENETIC

Genetic: Establishment of the genetic and immunologic profile Whole blood sampling : * 1 tube for the constitutional DNA extraction; * 3 tubes for ancillary studies and research. Collection of the available archival tumor sample (frozen or FFPE). If there's no available sample, the investigator will prescribe a biopsy of a reachable lesion. With the established profile, recommendations will be given by a multidisciplinary molecular board.

Blood and tumor samples

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• No tumor sample available.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (6)

Centre Hospitalier Annecy Genevois

Annecy, 74370, France

RECRUITING

Groupement Hospitalier Mutualiste

Grenoble, 38028, France

RECRUITING

Hôpital Edouard Herriot

Lyon, 69003, France

NOT YET RECRUITING

Centre Léon Bérard

Lyon, 69008, France

RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

ACTIVE NOT RECRUITING

CHU de Saint-Etienne Hôpital Nord

Saint-Etienne, 42055, France

RECRUITING

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MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jean-Yves BLAY, MD PhD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Yves BLAY, MD

CONTACT

+33 4 78 78 51 26; jean-yves.blay@lyon.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 24, 2013
• Study Start: February 1, 2013
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-03

Locations

FR (6)