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Interest of Individual Biomarkers From the Identification of Tumor Genotype by High-throughput Molecular Techniques (BIOLYMPH2020)

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ClinicalTrials.gov Identifier: NCT04417803
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : February 20, 2024
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lymphomas Biological: Blood sampling Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : May 17, 2021
Estimated Primary Completion Date : May 2028
Estimated Study Completion Date : May 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
diffuse large B-cell lymphoma Biological: Blood sampling
plasmatic sampling
follicular lymphoma Biological: Blood sampling
plasmatic sampling
Hodgkin's lymphoma Biological: Blood sampling
plasmatic sampling


Outcome Measures
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Primary Outcome Measures :
  1. biomarkers [ Time Frame: through study completion, an average of 7 years ]
    identification of individual plasma biomarkers, based on cfDNA (cell-free DNA), by high-throughput sequencing of circulating ctDNA tumor DNA


Secondary Outcome Measures :
  1. tumour mutation profile [ Time Frame: through study completion, an average of 7 years ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417803


Contacts
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Contact: Olivier CASASNOVAS 0380295041 ext +33 olivier.casasnovas@chu-dijon.fr

Locations
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France
Chu Dijon Bourgogne Recruiting
Dijon, France, 21000
Contact: Olivier Casasnovas    03.80.29.50.41 ext +33    olivier.casasnovas@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
More Information
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT04417803    
Other Study ID Numbers: ROSSI 2020
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: February 20, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases