Integrated Molecular and Clinical Profiling to Optimize Outcome Prediction in Splenic Marginal Zone Lymphoma

Sponsor
International Extranodal Lymphoma Study Group (IELSG) (Other)
Overall Status
Completed
CT.gov ID
NCT02945319
Collaborator
(none)
373
1
47
7.9

Study Details

Study Description

Brief Summary

The study aims at developing and validating an integrated clinico-molecular model for an accurate survival prognostication in newly diagnosed SMZL.

Already existing and coded tumor biological material and health-related personal data will be retrospectively collected. Mutation analysis will be performed by targeted deep next generation sequencing of tumor genomic DNA. Deletion of 7q will be assessed by FISH on nuclei isolated from tumor tissues. Immunoglobulin gene rearrangement and mutation status will be analyzed on tumor genomic DNA by PCR and Sanger sequencing. The methylation status of target genes will be assessed by methylation specific PCR on tumor genomic DNA.

The adjusted association between exposure variables and OS will be estimated by Cox regression. This approach will provide the covariates independently associated with OS that will be utilized in the development of a hierarchical molecular model to predict OS. The hierarchical order of relevance in predicting OS among covariates will be established by recursive partitioning analysis. An amalgamation algorithm will be used to merge terminal nodes showing homogenous OS. The discrimination capacity of the model will be assessed by calculating the c-index. Relative survival analysis will be used to provide a measure of the excess mortality experienced by patient's subgroups stratified according to the developed hierarchical molecular models, irrespective of whether the excess mortality is directly or indirectly attributable to the disease. The model developed in the training set will be tested in the validation sets and the model performance (c-index) in the validation set will be compared with that in the training set.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    373 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Actual Study Start Date :
    Jan 1, 2017
    Actual Primary Completion Date :
    Dec 1, 2020
    Actual Study Completion Date :
    Dec 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival (OS) [From date of enrollment to study ending at 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Male or female adults 18 years or older

    • Diagnosis of SMZL on spleen histology before Dec 31st 2010 (to provide the cohort with a minimum follow-up of at least 5 years)

    • Availability of tumor material (from spleen, peripheral blood or bone marrow) collected before initiation of medical therapy

    • Availability of the baseline and follow-up annotations

    Exclusion Criteria:
    • Having received any medical therapy including anti CD20 monoclonal antibody, chemotherapy or biological agents before splenectomy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IOSI Bellinzona Switzerland 6500

    Sponsors and Collaborators

    • International Extranodal Lymphoma Study Group (IELSG)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    International Extranodal Lymphoma Study Group (IELSG)
    ClinicalTrials.gov Identifier:
    NCT02945319
    Other Study ID Numbers:
    • IELSG46
    • NCT03288415
    First Posted:
    Oct 26, 2016
    Last Update Posted:
    Jun 7, 2021
    Last Verified:
    Jun 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 7, 2021