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

Nodal Marginal Zone Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05700149
• Other study ID #: IELSG52
• Status: Recruiting
• Start date: December 31, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: International Extranodal Lymphoma Study Group (IELSG)
• Contact: IELSG - Study Coordination Office
• Phone: +41 58 666 7321
• Email: ielsg[@]ior.usi.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female adults 18 years or older

2. Diagnosis of NMZL on lymph node histology after Jan 1st, 2000

3. Availability of tumor material from lymph node (either frozen or FFPE) collected when the patient was treatment naïve

4. Availability of the baseline and follow-up annotations

Exclusion Criteria:

1. Nodal spread of a clinically occult extranodal MZL (this must have been ruled out by carefully evaluating the extranodal tissues draining to the involved lymph nodes by imaging or endoscopy)

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Armenia	Hematology Center after Prof. Yeolyan	Yerevan
France	APHP, Saint Louis Hospital	Paris
Italy	IRCCS - Azienda Ospedaliero-Universitaria di Bologna	Bologna
Switzerland	University Hospital Basel	Basel
Switzerland	Oncology Institute of Southern Switzerland and Institute of Oncology Research	Bellinzona
Switzerland	Hôpitaux Universitaires Genevois	Genève
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
International Extranodal Lymphoma Study Group (IELSG)

Countries where clinical trial is conducted

United States,  Armenia,  France,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Define and quantify molecular subsets.		Two years: from the end of samples collection to the end of study analysis