Radiomics and Metabolomics in the Follow-up of CAR T-cells for Refractory or Relapsed Non-Hodgkin's Lymphoma
NCT ID: NCT05422521
Last Updated: 2024-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2022-08-29
2026-02-28
Brief Summary
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Detailed Description
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The search for circulating metabolites in serum (mass spectrometry) will be carried out during the pre-therapeutic assessment, then in the follow-up at 7 days, 1 month, 3 months, 6 months, 9 months and 12 months post treatment.
The main objective of the study is the comparison of signatures from radiomics and early serum metabolomic indices according to progression-free survival at 12 months of patients treated with CAR T-cells for refractory or relapsed non-Hodgkin's lymphoma, in correlation with clinical and biological monitoring, to predict tumor response.
The secondary objective is the comparison of the signatures of early serum radiomic and metabolic indices according to the occurrence of serious clinical and/or biological side effects in the 12 months following treatment with CAR T cells.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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identification of predictive and prognostic biomarkers
blood samples and 18FDG PET-CT exams
* 18 FDG PET scanner at inclusion and post CART-cells treatment ( 1, 3, 6, 9 and 12 month)
* blood collection at inclusion and post CART-cells treatment (7 days, 1 month and 3 month)
Interventions
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blood samples and 18FDG PET-CT exams
* 18 FDG PET scanner at inclusion and post CART-cells treatment ( 1, 3, 6, 9 and 12 month)
* blood collection at inclusion and post CART-cells treatment (7 days, 1 month and 3 month)
Eligibility Criteria
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Inclusion Criteria
* Patients with histologically proven, refractory or relapsed, non-Hodgkin's lymphoma as indicated for CAR T-cell therapy
* ECOG score 0 to 2
* Affiliated patient or beneficiary of a social security scheme
* Patient having signed prior informed consent.
Exclusion Criteria
* Contraindication to performing 18FDG PET-CT examinations: severe claustrophobia, unbalanced diabetes during PET-CT examinations (young capillary blood sugar ≥ 11 mmol),
* Any participation in other biomedical studies relating to drugs, medical devices or imaging techniques is prohibited, with the exception of so-called non-health product biomedical studies.
* Hypersensitivity to the active substance or to any of the excipients in the composition of CAR T-cells preparations
* Pregnant or breastfeeding women
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Principal Investigators
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Philippe VIAU
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nice
Locations
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CHU de Nice
Nice, , France
Countries
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Central Contacts
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Mickael LOSCHI, MD
Role: CONTACT
Facility Contacts
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Valérie Foussat
Role: primary
Other Identifiers
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21-AOIP-03
Identifier Type: -
Identifier Source: org_study_id
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