Interest of Individual Biomarkers From the Identification of Tumor Genotype by High-throughput Molecular Techniques (BIOLYMPH2020)
Primary Purpose
Lymphomas
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
About this trial
This is an interventional other trial for Lymphomas
Eligibility Criteria
Inclusion Criteria:
- Person who has not opposed to their inclusion in the trial
- Confirmation of the diagnosis of one of the three lymphomas (DGLBL, LF or classic LH) according to the WHO 2016 international classification (Smerdlow et al, 2016)
- Patients not currently taking treatment for their haemopathy (or who have received corticosteroid therapy alone within 14 days prior to the 1st sampling, dose limited to 500mg total)
- Patients requiring systemic treatment within 30 days of screening
- PET images available for pre-therapy and follow-up (mid-treatment, end of treatment)
Exclusion Criteria:
- Person subject to legal protection (curatorship, guardianship)
- Person under partial judicial control
- Pregnant, parturient or breastfeeding woman
- Adult incapable or incapable of giving consent
- Minor
- Localized lymphoma treated by surgery and/or localized radiotherapy
Sites / Locations
- Chu Dijon BourgogneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
diffuse large B-cell lymphoma
follicular lymphoma
Hodgkin's lymphoma
Arm Description
Outcomes
Primary Outcome Measures
biomarkers
identification of individual plasma biomarkers, based on cfDNA (cell-free DNA), by high-throughput sequencing of circulating ctDNA tumor DNA
Secondary Outcome Measures
tumour mutation profile
Description of the tumour mutation profile using different molecular biology techniques (CAPP-seq, PHASE-seq, VIRCAPP-seq) by analysing circulating tumour DNA (ctDNA) from cfDNA
Full Information
NCT ID
NCT04417803
First Posted
May 28, 2020
Last Updated
December 7, 2021
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT04417803
Brief Title
Interest of Individual Biomarkers From the Identification of Tumor Genotype by High-throughput Molecular Techniques
Acronym
BIOLYMPH2020
Official Title
Interest of Individual Biomarkers From the Identification of Tumor Genotype in Plasma (ctDNA: Circulating Tumor DNA) by High-throughput Molecular Next Generation Techniques(CAPP Seq, PhAsE Seq, VIRCAPP-seq) in the Diagnosis and Personalized Management of Lymphomas in a Prospective Monocentric Cohort
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
May 2028 (Anticipated)
Study Completion Date
May 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Lymphomas are the most common haemopathic malignancy. The 3 most common types are diffuse large B-cell lymphoma (DLBCL), Hodgkin's lymphoma (HL) and follicular lymphoma (FL). In these three subtypes, the treatment strategy is most often curative. The therapeutic strategy is guided by PET (positron emission tomography), which optimises the risk-benefit balance between the efficacy and toxicity of the treatment and makes it possible to limit the intensity of treatment for good responders and to intensify the treatment of poor responders with a worse prognosis. PET therefore plays a central role in the pre-therapeutic evaluation of the disease and in the assessment of response to treatment. However, other complementary approaches could improve characterization prior to initiating lymphoma t-treatment and individual patient management during treatment and beyond. In DLBCL, it has been shown that the risk of relapse of good and bad responders is decreased by combining the PET response with a reduction in the amount of tumor DNA (ctDNA) in the blood, i.e. the genetic program of lymphoma cells that circulates freely in the blood. This evaluation of ctDNA has been made possible by the development of innovative techniques such as Next Generation Sequencing (NGS). In lymphomas, several approaches have been developed, the most sensitive and promising being CAPP-Seq (CAncer Personalized Profiling by deep Sequencing) developed at Stanford University.
It is therefore useful to study the description of ctDNA in the 3 types of lymphomas and to analyse the progression profiles under treatment by trying to establish the major potential usefulness of these techniques: modifying treatment in case of poor response based on ctDNA +/- and PET, detecting relapses earlier than at present in patients without any other sign of relapse (clinical, blood or PET).
The project presented here aims to build a collection of plasma samples taken before treatment, during treatment and during the first 2 years of follow-up in patients with one of the 3 most frequent types of lymphoma and undergoing curative treatment. The hypothesis is that sequential evaluation of ctDNA could improve the individualized management of future patients based on the results generated by the analyses of patients in this cohort.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphomas
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
diffuse large B-cell lymphoma
Arm Type
Other
Arm Title
follicular lymphoma
Arm Type
Other
Arm Title
Hodgkin's lymphoma
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Description
plasmatic sampling
Primary Outcome Measure Information:
Title
biomarkers
Description
identification of individual plasma biomarkers, based on cfDNA (cell-free DNA), by high-throughput sequencing of circulating ctDNA tumor DNA
Time Frame
through study completion, an average of 7 years
Secondary Outcome Measure Information:
Title
tumour mutation profile
Description
Description of the tumour mutation profile using different molecular biology techniques (CAPP-seq, PHASE-seq, VIRCAPP-seq) by analysing circulating tumour DNA (ctDNA) from cfDNA
Time Frame
through study completion, an average of 7 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Person who has not opposed to their inclusion in the trial
Confirmation of the diagnosis of one of the three lymphomas (DGLBL, LF or classic LH) according to the WHO 2016 international classification (Smerdlow et al, 2016)
Patients not currently taking treatment for their haemopathy (or who have received corticosteroid therapy alone within 14 days prior to the 1st sampling, dose limited to 500mg total)
Patients requiring systemic treatment within 30 days of screening
PET images available for pre-therapy and follow-up (mid-treatment, end of treatment)
Exclusion Criteria:
Person subject to legal protection (curatorship, guardianship)
Person under partial judicial control
Pregnant, parturient or breastfeeding woman
Adult incapable or incapable of giving consent
Minor
Localized lymphoma treated by surgery and/or localized radiotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier CASASNOVAS
Phone
0380295041
Ext
+33
Email
olivier.casasnovas@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Casasnovas
Phone
03.80.29.50.41
Ext
+33
Email
olivier.casasnovas@chu-dijon.fr
12. IPD Sharing Statement
Learn more about this trial
Interest of Individual Biomarkers From the Identification of Tumor Genotype by High-throughput Molecular Techniques
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