Personalized Risk Stratification Model of Follicular Lymphoma Patients

NCT ID: NCT03436602

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 370 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2026-10-31

Brief Summary

The study aims at developping and validating an integrated clinico-molecular model for an accurate identification of FL patients who are progression free and progressed, respectively, at 24 months after treatment.

Detailed Description

Already existing and coded tumor biological material and health-related personal data will be retrospectively collected. FL diagnosis will be confirmed by central pathology review. Tumor somatic mutations, immunoglobulin gene rearrangement and mutation status will be analyzed by targeted deep next generation sequencing of tumor genomic DNA. Gene expression profiling will be performed by targeted RNA-Seq of biopsy-derived RNA.

An immunohistochemistry panel assessing both tumor phenotype and microenvironment cellular composition will be assessed by Tissue macroarray. FISH will be performed to characterize the most recurrent follicular lymphoma chromosomal translocations.

The adjusted association between exposure variables and progression free survival will be estimated by Cox regression. This approach will provide the covariates independently associated with progression free survival that will be utilized in the development of a hierarchical molecular model to predict progression free survival at 24 months. The hierarchical order of relevance in predicting 24 months progression free survival among covariates will be established by recursive partitioning analysis. Overall, this approach will allow the development of a multilayer dynamic model for anticipating progression within 24 months from treatment.

The model developed in the training set will be tested in the validation sets and the model performance (c-index and net reclassification improvement) in the validation set will be compared with that in the training set. The accuracy of the multilayer model in predicting progression free survival at 24 months will be compared against the FLIPI using c-index and net reclassification improvement.

Conditions

Follicular Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Training cohort

Cohort of follicular lymphoma patients for the development of the multilayer risk stratification model

No interventions assigned to this group

Validation cohort

Cohort of follicular lymphoma patients for the validation of the developed multilayer risk stratification model

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Diagnosis of FL after January 1st, 2004 (chemoimmunotherapy era)
• Availability of tumor material collected before initiation of medical therapy
• Availability of the baseline and follow-up annotations

Exclusion Criteria

• None.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role: collaborator

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: collaborator

Institute of Pathology, Locarno, Ticino, Switzerland

UNKNOWN

Sponsor Role: collaborator

Oncology Institute of Southern Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Davide Rossi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oncology Institute of Southern Switzerland

Locations

Arcispedale Santa Maria Nuova, AUSL IRCSS, Hematology Department

Reggio Emilia, RE, Italy

Azienda Ospedaliera Universitaria Maggiore della Carità

Novara, , Italy

Institute of Oncology Research

Bellinzona, Canton Ticino, Switzerland

Institute of Pathology

Locarno, Canton Ticino, Switzerland

Countries

Italy; Switzerland

Other Identifiers

IOSI-EMA-004

Identifier Type: -

Identifier Source: org_study_id