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NeoplasmsPROFILERNCT01774409

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

A study testing Blood and tumor samples in people with Neoplasms, run by Centre Leon Berard at 6 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Neoplasms
What is being tested?
Blood and tumor samples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,000 participants
Where
6 sitesFrance
Study dates
Feb 2013to Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • No tumor sample available.

Trial locations and contacts

6 sites in 1 country.

Jean-Yves BLAY, MD contact

+33 4 78 78 51 26

jean-yves.blay@lyon.unicancer.fr

6 sites in 1 country

France6 sites, 5 recruiting

  • Centre Hospitalier Annecy Genevois

    Annecy, 74370

    Mélodie Carbonnaux, MD

    Mathieu Baconnier, MD

    Recruiting

  • Groupement Hospitalier Mutualiste

    Grenoble, 38028

    Cécile LEYRONNAS, MD

    Recruiting

  • Hôpital Edouard Herriot

    Lyon, 69003

    Julien FORESTIER, MD

    Catherine LOMBARD BOHAS, MD

    Not yet recruiting

  • Centre Léon Bérard

    Lyon, 69008

    Thomas BACHELOT, MD

    Amine BELHABRI, MD

    Recruiting

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

    Active, not recruiting

  • CHU de Saint-Etienne Hôpital Nord

    Saint-Etienne, 42055

    Pierre Fournel, MD

    Claire Bosacki, MD

    Recruiting

Other trials in France

About this study

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.

Read the 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.

Conditions
Neoplasms
Being tested
Blood and tumor samples
Keywords
all advanced malignant tumor
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood and tumor samplesGenetic

    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.

Study groups in NCT01774409
Study groupRoleWhat they receive
Blood and tumor samplesExperimentalNot described
Receives: Genetic: Blood and tumor samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at least 3 years after patient enrollment

Secondary outcomes (9)

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

    Description of the incidence rates of each detected immunologic disorder in the global cohort and for each histological type.

    Measured: at least 3 years after patient enrollment

  2. 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.

    Comparison of the genetic and immunologic profiles between patients with the same tumor type or between tumors of different types.

    Measured: at least 3 years after patient enrollment

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

    Tumor response (determined by the investigator and/or the radiologist) assessed after each treatment received by the patient during his/her whole participation to the study (if data are available in the medical record).

    Measured: at least 3 years after patient enrollment

  4. 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

    lymphopenia, over-representation of Treg, dendritic cells alterations,

    Measured: at least 3 years after patient enrollment

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

    Measured: at least 3 years after patient enrollment

  6. 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

    A description will be done of therapie(s) recommanded and/or received by patients based on recommandation done by the Molecular Tumor Board after reviewing of molecular profil

    Measured: at least 3 years after patient enrollment

  7. Describe the clinical impact of this molecular profiling in term of PFS

    Progression free survival for each recommanded therapies received

    Measured: at least 3 years after patient enrollment

  8. Describe the clinical impact of this molecular profiling in term of OS

    Overall survival for each recommanded therapies received

    Measured: at least 3 years after patient enrollment

  9. Describe the clinical impact of this molecular profiling in term of tumor response

    Tumoral response (clinic and/or radiologic) for each recommanded therapies received

    Measured: at least 3 years after patient enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionJul 2025 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01774409
Sponsor's protocol ID
PROFILER
Other IDs
ET12-082
Acronym
PROFILER
Status last verified
Mar 2024
First submitted
16 Jan 2013
Last updated
4 Mar 2024
Results posted
No
Data monitoring committee
No

Publications

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    PubMed 19360079

  • Diaz-Cano SJ. General morphological and biological features of neoplasms: integration of molecular findings. Histopathology. 2008 Jul;53(1):1-19. doi: 10.1111/j.1365-2559.2007.02937.x. Epub 2008 Feb 12.

    PubMed 18282144

  • Dancey JE, Bedard PL, Onetto N, Hudson TJ. The genetic basis for cancer treatment decisions. Cell. 2012 Feb 3;148(3):409-20. doi: 10.1016/j.cell.2012.01.014.

    PubMed 22304912

  • Chin L, Hahn WC, Getz G, Meyerson M. Making sense of cancer genomic data. Genes Dev. 2011 Mar 15;25(6):534-55. doi: 10.1101/gad.2017311.

    PubMed 21406553

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    PubMed 20393554

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Questions about this trial

What is this clinical trial studying?

A study testing Blood and tumor samples in people with Neoplasms, run by Centre Leon Berard at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jean-Yves BLAY, MD (+33 4 78 78 51 26, jean-yves.blay@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Establish a map of genetic profiles (for the pre-identified target genes) for all types of advanced malignant tumors. (time frame: at least 3 years after patient enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01774409, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.

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