Personalized Risk Stratification Model of Follicular Lymphoma Patients

Multilayer Model for Personalized Risk Stratification of Follicular Lymphoma Patients

Sponsors

Lead Sponsor: Oncology Institute of Southern Switzerland

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

Source Oncology Institute of Southern Switzerland
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.

Overall Status Recruiting
Start Date March 1, 2018
Completion Date March 2021
Primary Completion Date March 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Accuracy of multilayer personalized stratification model 24 months after first line treatment
Secondary Outcome
Measure Time Frame
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
Enrollment 650
Condition
Eligibility

Sampling Method: Probability Sample

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Davide Rossi, MD, PhD Principal Investigator Oncology Institute of Southern Switzerland
Overall Contact

Last Name: Davide Rossi, MD, PhD

Phone: +41 091 811 8540

Email: [email protected]

Location
Facility: Status: Contact:
Arcispedale Santa Maria Nuova, AUSL IRCSS, Hematology Department | Reggio Emilia, RE, 42123, Italy Recruiting Stefano Luminari, Prof. [email protected]
Azienda Ospedaliera Universitaria Maggiore della Carità | Novara, 28100, Italy Recruiting Gianluca Gaidano, Prof. [email protected]
Institute of Oncology Research | Bellinzona, Tessin, 6500, Switzerland Recruiting Davide Rossi, MD, PhD [email protected]
Institute of Pathology | Locarno, Tessin, Switzerland Recruiting Luca Mazzucchelli, Prof. [email protected]
Location Countries

Italy

Switzerland

Verification Date

December 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Oncology Institute of Southern Switzerland

Investigator Full Name: Davide Rossi

Investigator Title: MD, PhD, Senior Consultant, Hematology Department

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Training cohort

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

Label: Validation cohort

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

Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov