Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03436602

Personalized Risk Stratification Model of Follicular Lymphoma Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Follicular Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arcispedale Santa Maria Nuova, AUSL IRCSS, Hematology Department, Reggio Emilia, RE, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Accuracy of multilayer personalized stratification model

    Time frame: 24 months after first line treatment

    Assessment of multilayer personalized stratification model accuracy in the identification of patients who are progression free at 24 months after first line therapy plus the proportion of patients correctly identified as progressed within 24 months after first line therapy

Secondary outcomes

  1. Progression free survival

    Time frame: From treatment start to progression / death / last follow-up, up to 13 years of follow-up

    Time elapsed from treatment start to progression (event), death (event) or last follow-up (censoring)

  2. Overall survival

    Time frame: From treatment start to death / last follow-up, up to 13 years of follow-up

    Time elapsed from treatment start to death (event) or last follow-up (censoring)

  3. Time to transformation

    Time frame: From treatment start to transformation or progression without transformation or death or last follow-up, up to 13 years of follow-up

    Time elapsed between treatment start and transformation (event), progression without transformation (censoring), death (censoring) or last follow-up (censoring)

Sponsors and collaborators

Lead sponsor

Oncology Institute of Southern Switzerland

Other

Collaborators

  • Azienda Ospedaliero Universitaria Maggiore della Carita
  • Azienda USL Reggio Emilia - IRCCS
  • Institute of Pathology, Locarno, Ticino, Switzerland

Registry information

Official study title

Multilayer Model for Personalized Risk Stratification of Follicular Lymphoma Patients

Important dates

Study start
2018
Primary completion
2021
Study completion
2026
First posted
Feb 19, 2018
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.