Personalized Risk Stratification Model of Follicular Lymphoma Patients

Follicular Lymphoma Clinical Trial

Official title:

Multilayer Model for Personalized Risk Stratification of Follicular Lymphoma Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03436602
• Other study ID #: IOSI-EMA-004
• Status: Active, not recruiting
• Start date: March 1, 2018
• Est. completion date: October 31, 2023

Study information

• Verified date: March 2023
• Source: Oncology Institute of Southern Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 370
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Maggiore della Carità	Novara
Italy	Arcispedale Santa Maria Nuova, AUSL IRCSS, Hematology Department	Reggio Emilia	RE
Switzerland	Institute of Oncology Research	Bellinzona	Tessin
Switzerland	Institute of Pathology	Locarno	Tessin

Sponsors (4)

Lead Sponsor	Collaborator
Oncology Institute of Southern Switzerland	Arcispedale Santa Maria Nuova-IRCCS, Azienda Ospedaliero Universitaria Maggiore della Carita, Institute of Pathology, Locarno, Ticino, Switzerland

Countries where clinical trial is conducted

Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression free survival	Time elapsed from treatment start to progression (event), death (event) or last follow-up (censoring)	From treatment start to progression / death / last follow-up, up to 13 years of follow-up
Secondary	Overall survival	Time elapsed from treatment start to death (event) or last follow-up (censoring)	From treatment start to death / last follow-up, up to 13 years of follow-up
Secondary	Time to transformation	Time elapsed between treatment start and transformation (event), progression without transformation (censoring), death (censoring) or last follow-up (censoring)	From treatment start to transformation or progression without transformation or death or last follow-up, up to 13 years of follow-up