NCT05700149

Integrated Molecular and Clinical Profiling to Improve Disease Characterization and Outcome Prediction in Nodal Marginal Zone Lymphoma

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: International Extranodal Lymphoma Study Group (IELSG) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

International retrospective observational cohort study aimed to describe a molecular classification for NMZL.

Detailed description

Already existing and coded tumor biological material and health-related patient data will be retrospectively collected from institutional biobanks and patients' charts or electronic medical records upon receipt of ethical approval. Each patient enrolled in the study will be assigned to a unique identification numerical code upon registration in the study. The unique identification code will be used to record health-related data and to label biological samples. The coded biological material will be transferred to the coordinating center at the Oncology Institute of Southern Switzerland and Institute of Oncology Research in Bellinzona. Health-related data will be collected in the eCRF (OpenClinica). Data quality will be insured by query generation. Annotated baseline features will include date of diagnosis, date of lymph node biopsy, age, gender, ECOG PS, Ann Arbor stage, LDH, number and location of extranodal sites, bone marrow involvement and percentage, peripheral blood involvement, number of nodal sites, B symptoms, lymph nodes larger than 7 cm, Hb, platelets, lymphocytes, beta-2-microglobulin, albumin, HCV infection, serum paraprotein and type. Annotated follow-up features included date of progression to a disease requiring treatment, type of first line treatment, date of start of first line treatment, date of progression after first line treatment, date of second line treatment, type of second line treatment, date of transformation, date of death, cause of death, date of last follow-up. Mutation analysis, immunoglobulin gene rearrangement analysis, copy number aberration analysis, structural variant analysis and DNA methylation profile will be performed by next generation sequencing of genomic DNA extracted from the lymph node biopsy. Gene expression will be assessed by next generation sequencing of RNA extracted from the lymph node biopsy.

Conditions

• Nodal Marginal Zone Lymphoma

Timeline

• Start date: 2024-04-11
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-01-26
• Last updated: 2026-01-16

Locations

36 sites across 8 countries: United States, Armenia, Croatia, Italy, Portugal, South Korea, Switzerland, United Kingdom