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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03234140




Registration number
NCT03234140
Ethics application status
Date submitted
26/07/2017
Date registered
31/07/2017
Date last updated
31/07/2017

Titles & IDs
Public title
Constitutional Genetics in Follicular Lymphoma
Scientific title
Constitutional Genetics to Predict Prognostic and Somatic Alterations in Follicular Lymphoma
Secondary ID [1] 0 0
69HCL17_0212
Universal Trial Number (UTN)
Trial acronym
CONPIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma 0 0
Genetic Predisposition to Disease 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Genome Wide Association Studies
Other interventions - Single-nucleotide polymorphisms's genotyping

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.

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.


Other interventions: 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.

Other interventions: Single-nucleotide polymorphisms's genotyping
Analyze of the influence of single-nucleotide polymorphisms on circulating t(14;18) levels
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Free Survival
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Somatic alterations and tumor biology
Timepoint [1] 0 0
2 years

Eligibility
Key inclusion criteria
Group "Genome Wide Association Studies"



- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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"

Inclusion Criteria:

- 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



- 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

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2019
Actual
Sample size
Target
1883
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Pierre-Bénite

Funding & Sponsors
Primary sponsor type
Other
Name
Hospices Civils de Lyon
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03234140
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Hervé Ghesquières, Pr
Address 0 0
Country 0 0
Phone 0 0
04 78 86 43 01
Fax 0 0
Email 0 0
herve.ghesquieres@chu-lyon.fr
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03234140