Identifying biomarkers in Diffuse Large B-cell Lymphoma
Mixed Molecular Clinical Index (MMCI) in Diffuse Large B-cell Lymphoma (DLBCL)
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · NCT04300101
This study is trying to find new markers in tissue samples that can help predict how well patients with Diffuse Large B-cell Lymphoma will do over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS (other) |
| Locations | 4 sites (Meldola, FC and 3 other locations) |
| Trial ID | NCT04300101 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify new prognostic biomarkers for patients with Diffuse Large B-cell Lymphoma (DLBCL) by analyzing both prospective and retrospective cohorts. It focuses on assessing progression-free survival and overall survival while characterizing the immune microenvironment through advanced transcriptomics. The study will also explore the correlation between gene expression, mutational status, and clinical outcomes using tissue samples and PET imaging. By integrating these factors, the research seeks to enhance predictive capacity beyond existing clinical factors.
Who should consider this trial
Good fit: Ideal candidates include patients newly diagnosed with high-grade Diffuse Large B-cell Lymphoma who are undergoing first-line standard treatment.
Not a fit: Patients currently enrolled in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic assessments and personalized treatment strategies for DLBCL patients.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for DLBCL, but this approach may offer novel insights into the disease's complexity.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for the prospective cohort: * New diagnosis of High grade Diffuse large B cell Lymphoma undergoing first line standard treatment; * Signed written informed consent; * Availability of FFPE sample. Inclusion Criteria for the retrospective cohort: * Diagnosis of High grade Diffuse large B cell Lymphoma from 2011 to 2017; * Availability of FFPE sample and clinical data. Exclusion Criteria: * Patients included in clinical trials.
Where this trial is running
Meldola, FC and 3 other locations
- Irst Irccs — Meldola, FC, Italy (RECRUITING)
- Ospedale S. Maria delle Croci RAVENNA — Ravenna, RA, Italy (RECRUITING)
- L'Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola-Malpighi — Bologna, Italy (RECRUITING)
- Ospedale Infermi — Rimini, Italy (RECRUITING)
Study contacts
- Principal investigator: Gerardo Musuraca, MD — IRST IRCCS
- Study coordinator: Oriana Nanni, Dr
- Email: oriana.nanni@irst.emr.it
- Phone: +39 0543739100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diffuse Large B Cell Lymphoma, Diffuse Large B cell lymphoma, cell of origin, gene expression, immunohistochemistry