NCT06588205 Exploring the Clinical Impact of MYC Aberrations and Their Relationship With Microenvironment in Diffuse Large B Cell Lymphoma and High-Grade B Cell Lymphoma
| NCT ID | NCT06588205 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Italiana Linfomi - ETS |
| Condition | Diffuse Large B Cell Lymphoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-05-05 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-05-05 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a observational, retrospective and prospective study designed to assess the potential correlations between MYC alterations, lymphoma mutational landscape and functional immune contextures in Diffuse Large B-cell Lymphoma or High-Grade B-cell Lymphoma
Eligibility Criteria
Inclusion Criteria: * Diagnosis of nodal and extranodal Diffuse Large B Cell Lymphoma, High Grade B Cell Lymphomas (including low-grade transformed lymphomas; double and triple hit; 11q aberration; not otherwise specified) after 1st January 2019 * Presence of one MYC translocation or gain of copies (GCN: \> 3 copies in more than 30% of the nuclei) or amplification evaluated by FISH * Availability of immunohistochemical analysis of CD10, Bcl6, MUM1, Bcl2, Myc, Ki67 * Have received curative treatment (e.g. R-CHOP, R DA EPOCH, intensified "Burkitt like" chemotherapies) as first-line therapy * Histological material of adequate size and quality to perform histological review with any additional investigations (immunohistochemistry, FISH and other molecular analysis). A FFPE block must be provided for patient enrollment. * Age between 18 and 79 years Exclusion Criteria: * Primary lymphomas of the central nervous system, plasmablastic lymphoma, Burkitt's lymphoma, primary mediastinal B lymphoma * Have received palliative treatment
Contact & Investigator
Luisa Lorenzi, MD
PRINCIPAL INVESTIGATOR
SC Anatomia Patologica - ASST Spedali Civili di Brescia
Frequently Asked Questions
Who can join the NCT06588205 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Diffuse Large B Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06588205 currently recruiting?
Yes, NCT06588205 is actively recruiting participants. Contact the research team at startup@filinf.it for enrollment information.
Where is the NCT06588205 trial being conducted?
This trial is being conducted at Alessandria, Italy, Ancona, Italy, Bari, Italy, Brescia, Italy and 11 additional locations.
Who is sponsoring the NCT06588205 clinical trial?
NCT06588205 is sponsored by Fondazione Italiana Linfomi - ETS. The principal investigator is Luisa Lorenzi, MD at SC Anatomia Patologica - ASST Spedali Civili di Brescia. The trial plans to enroll 200 participants.