SMZL Molecular Prognostic Index

Splenic Marginal Zone Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03288415
• Other study ID #: IELSG46
• Status: Active, not recruiting
• Start date: January 2017
• Est. completion date: November 2020

Study information

• Verified date: March 2020
• Source: Oncology Institute of Southern Switzerland
• Contact: n/a
• Is FDA regulated: No
• 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: November 2020
• Est. primary completion date: June 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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Splenic Marginal Zone Lymphoma

Locations

Country	Name	City	State
Switzerland	Oncology Institute of Southern Switzerland	Bellinzona

Sponsors (2)

Lead Sponsor	Collaborator
Oncology Institute of Southern Switzerland	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)	Overall survival will be measured from the time of diagnosis until death or last follow-up.	From diagnosis to death or last follow-up, with a minimum follow-up of at least 5 years