Personalized Risk Stratification Model of Follicular Lymphoma Patients

NCT03436602 | Active Not Recruiting

• 1 other identifier: IOSI-EMA-004
• Study Type: observational
• Target: 370
• Locations: 2 countries
• Sites: 4

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.

Conditions

Follicular Lymphoma

Keywords

Personalized risk assessment; Risk stratification model

Outcome Measures

Primary Outcomes (1)

• Accuracy of multilayer personalized stratification model

  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

  24 months after first line treatment

Secondary Outcomes (3)

• Progression free survival

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

• Overall survival

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

• Time to transformation

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

Study Arms (2)

Training cohort

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

Validation cohort

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Follicular lymphoma patients

You may qualify if:

• 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

You may not qualify if:

• None.

Sponsors & Collaborators

• Oncology Institute of Southern Switzerland: lead
• Azienda Ospedaliero Universitaria Maggiore della Carita: collaborator
• Azienda USL Reggio Emilia - IRCCS: collaborator
• Institute of Pathology, Locarno, Ticino, Switzerland: collaborator

Study Sites (4)

Arcispedale Santa Maria Nuova, AUSL IRCSS, Hematology Department

Reggio Emilia, RE, 42123, Italy

Location

Azienda Ospedaliera Universitaria Maggiore della Carità

Novara, 28100, Italy

Location

Institute of Oncology Research

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Institute of Pathology

Locarno, Canton Ticino, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

FFPE tissue specimen

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

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

Study Officials

• Davide Rossi, MD, PhD

  Oncology Institute of Southern Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 19, 2018
• Study Start: March 1, 2018
• Primary Completion: October 31, 2021
• Study Completion (Estimated): October 31, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

IT (2); CH (2)