MedDataX Logo

Constitutional Genetics in Follicular Lymphoma

NCT ID: NCT03234140

Last Updated: 2017-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1883 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-30

Study Completion Date

2019-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Follicular lymphoma is the second most common adult B-cell lymphoma. The acquisition of the t(14;18) translocation is the genetic hallmark of Follicular lymphoma. However, 50% to 70% of healthy individuals harbor low levels of circulating t(14;18)-positive cells but will never develop Follicular lymphoma. It was observed that individuals who developed Follicular lymphoma showed a higher t(14;18) frequency than controls (Roulland et al., J Clin Oncol 2014). High t(14;18) frequency in blood from healthy individuals could be a predictive biomarker for Follicular lymphoma development. Genetic instability of those t(14;18)+ B-cells as well as failure of the micro-environment to control the proliferation of these cells are proposed mechanisms linking these lymphoma precursors to true lymphoma cells. The prognosis of Follicular lymphoma patients has been significantly improved mainly with the development of anti-CD20 monoclonal antibodies, with a current median overall survival over 15 years. However, this lymphoma remains an incurable disease. The most commonly used tool for prognostication of patients with Follicular lymphoma is the Follicular Lymphoma International Prognostic Index (FLIPI) based on conventional clinical and pathology parameters. Although it has clinical utility, the Follicular Lymphoma International Prognostic Index does not reflect the biologic heterogeneity of Follicular lymphoma. First-degree relatives of Follicular lymphoma had a fourfold increased risk of Follicular lymphoma suggesting a genetic etiology.

Using the Genome wide association studies (GWAS) approach on Follicular lymphoma cohorts of 1,565 patients, the project plan to identify new prognostic markers. These markers will then be analyzed to decipher the impact of host genetics on somatic alterations and tumor biology, using public or matched patient data. The investigators also plan to analyze the influence of single-nucleotide polymorphisms on circulating t(14;18) levels in 318 healthy individuals included in EPIC cohort that will develop Follicular lymphoma later on, and assess if these biomarkers are helpful to refine the identification of high-risk Follicular lymphoma individuals.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Follicular Lymphoma Genetic Predisposition to Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group "Genome Wide Association Studies"

Patients are adults, male or female, with a follicular lymphoma, homogeneously treated by immunochemotherapy included in one of the following cohorte :

* PRIMA Cohort : phase III (Sponsor LYSARC, France; NCT00140582): N=396
* RELEVANCE Cohort : phase III (Sponsor LYSARC, France; NCT01476787 ): N=441
* FOLL05 Cohort: phase III (Sponsor Italian lymphoma Foundation, Italy; NCT00774826): N=229
* MER1 Cohorts : prospective, observational (Sponsor Mayo Clinic, USA; IRB#09-001987): N=178
* MER2 Cohorts : prospective, observational (Sponsor Mayo Clinic, USA; IRB#09-001987):N=321

Using the Genome wide association studies (GWAS) approach on these 1,565 patients, the project plan to identify new prognostic markers. These markers will then be analyzed to decipher the impact of host genetics on somatic alterations and tumor biology, using public or matched patient data.

Genome Wide Association Studies

Intervention Type GENETIC

Using the Genome wide association studies (GWAS) approach on these 1,565 patients, the project plan to identify new prognostic markers. These markers will then be analyzed to decipher the impact of host genetics on somatic alterations and tumor biology, using public or matched patient data.

Group "EPIC"

Patients are adults, male or female, included in the EPIC Cohort (European Prospective Investigation Into Cancer and Nutrition study between 1992 and 2000. (Sponsor IARC, Lyon, France).

The investigators plan to analyze the influence of single-nucleotide polymorphisms on circulating t(14;18) levels in these 318 healthy individuals including 100 who will develop follicular lymphoma later on, and assess if these biomarkers are helpful to refine the identification of high-risk follicular lymphoma individuals.

Single-nucleotide polymorphisms's genotyping

Intervention Type GENETIC

Analyze of the influence of single-nucleotide polymorphisms on circulating t(14;18) levels

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Genome Wide Association Studies

Using the Genome wide association studies (GWAS) approach on these 1,565 patients, the project plan to identify new prognostic markers. These markers will then be analyzed to decipher the impact of host genetics on somatic alterations and tumor biology, using public or matched patient data.

Intervention Type GENETIC

Single-nucleotide polymorphisms's genotyping

Analyze of the influence of single-nucleotide polymorphisms on circulating t(14;18) levels

Intervention Type GENETIC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Follicular lymphoma treated in first line therapy treated by immunochemotherapy (PRIMA, FOL05, MER1 and 2, control arm of RELEVANCE trial)
* Follicular lymphoma treated in first line therapy by Rituximab and Lenalidomide as part of the investigational arm of RELEVANCE trial
* Available constitutional DNA samples for GWAS analysis with an accurate consent form for such genetic study
* Available biological and clinical characteristics at diagnosis with a follow-up of the patient for event free survival analysis
* 18 years of age or older


* Included in the EPIC Cohort (European Prospective Investigation into Cancer and nutrition study between 1992 and 2000)
* Available constitutional DNA samples with an accurate consent form for such genetic study
* 18 years of age or older

Exclusion Criteria

* A non-follicular lymphoma histology according to WHO 2016 classification (grade 1, 2, 3a follicular lymphoma)
* Relapsed follicular lymphoma
* Patients without an accurate consent form for constitutional genetic study
* Patients with no available biological or clinical data and follow-up for the outcome analysis

Group "EPIC"


* Patients without an accurate consent form for constitutional genetic study
* Patients with no available biological or clinical data and follow-up for the outcome analysis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hervé Ghesquières, Pr

Role: CONTACT

Phone: 04 78 86 43 01

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hervé Ghesquières, Pr

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

69HCL17_0212

Identifier Type: -

Identifier Source: org_study_id