Integrated Molecular and Clinical Profiling to Improve Disease Characterization and Outcome Prediction in Nodal Marginal Zone Lymphoma
Rekrutierend
NCT-Nummer:
NCT05700149
Studienbeginn:
Dezember 2023
Letztes Update:
05.01.2024
Wirkstoff:
-
Indikation (Clinical Trials):
Lymphoma, Lymphoma, B-Cell, Marginal Zone
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
International Extranodal Lymphoma Study Group (IELSG)
Collaborator:
-
Studienleiter
Davide Rossi, MD
Study Chair
Oncology Institute of Southern Switzerland and Institute of Oncology Research
Kontakt
IELSG - Study Coordination Office
Kontakt:
Phone: +41 58 666 7321
E-Mail: ielsg@ior.usi.ch» Kontaktdaten anzeigen
Davide Rossi, MD
Kontakt:
Phone: +41 91 811 8540
E-Mail: davide.rossi@eoc.ch» Kontaktdaten anzeigen
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.
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)
Primary outcome:
1. Define and quantify molecular subsets. (Time Frame - Two years: from the end of samples collection to the end of study analysis)
Quelle: ClinicalTrials.gov
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