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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02945319
Other study ID # IELSG46
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date December 2020

Study information

Verified date June 2021
Source International Extranodal Lymphoma Study Group (IELSG)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Other known NCT identifiers
  • NCT03288415

Recruitment information / eligibility

Status Completed
Enrollment 373
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Switzerland IOSI Bellinzona

Sponsors (1)

Lead Sponsor Collaborator
International Extranodal Lymphoma Study Group (IELSG)

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival (OS) From date of enrollment to study ending at 2 years
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