Assessing Prognosis in Hodgkin Lymphoma
Changing Paragidms In The Prognostic Assessment Of Hodgkin Lymphoma
Azienda USL Reggio Emilia - IRCCS · NCT06822855
This study is trying to find better ways to predict how Hodgkin Lymphoma will progress in patients who have finished treatment or have had a relapse, using new tools and tests to help personalize their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 755 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda USL Reggio Emilia - IRCCS (other gov) |
| Drugs / interventions | chemotherapy |
| Locations | 12 sites (Milan, MI and 11 other locations) |
| Trial ID | NCT06822855 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on improving the prognostic assessment of Classical Hodgkin Lymphoma (cHL) by utilizing both retrospective and prospective cohorts. It includes patients who have completed treatment and are in follow-up, as well as those with confirmed relapse or progression. The study aims to integrate novel tools for monitoring tumor complexity and anticipating disease progression, addressing the limitations of current prognostic methods. By analyzing clinical, laboratory, and imaging data alongside liquid biopsy samples, the study seeks to enhance personalized treatment strategies for cHL patients.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with a confirmed diagnosis of relapsed or refractory Classical Hodgkin Lymphoma who have completed initial treatment.
Not a fit: Patients with early-stage Hodgkin Lymphoma who have not yet undergone treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate prognostic assessments and personalized treatment strategies for patients with Hodgkin Lymphoma.
How similar studies have performed: Other studies have shown promise in using advanced imaging and liquid biopsy techniques for prognostic assessment in similar hematological malignancies, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 anni * Written informed consent signed Cohort A * Age \>18 years * Histologically confirmed diagnosis of relapsed/refractory classical Hodgkin lymphoma identified during induction or follow-up * Available formalin-fixed, paraffin-embedded (FFPE) biopsy at diagnosis and at the time of progression/relapse * Available plasma sample at progression (before the beginning of salvage therapy) * Available FDG-PET evaluation at study enrollment * Available clinical, laboratory, and radiologic data at diagnosis and relapse Cohort B * Diagnosis of classical Hodgkin lymphoma * Completion of first-line standard systemic treatment (chemotherapy-based or chemoradiotherapy combined modality) * Available plasma sample at the end of treatment (at least 30 days from the last chemotherapy) * Available FFPE biopsy at diagnosis * No further treatment planned * Available clinical, laboratory, and radiologic data at diagnosis and response evaluation * Patient's willingness to undergo 6 months follow-up plasma sample collection and to attend regular follow-up Cohort C * Histologically confirmed diagnosis of classical Hodgkin lymphoma * Standard treatment as per available guidelines (e.g., ESMO guidelines) * Available treatment data, response, and follow-up data * Available FFPE biopsy at diagnosis * Available FDG-PET evaluation at study enrollment Exclusion Criteria: * Patients with nodular lymphocyte predominant Hodgkin lymphoma are not eligible; all other subtypes including nodular sclerosis, lymphocyte-depleted, lymphocyte-rich, and mixed cellularity Hodgkin lymphoma may be enrolled. * Active HIV, HBV, HCV viral infection * Concomitant neoplasm not treated with a curative aim
Where this trial is running
Milan, MI and 11 other locations
- ASST Grande Ospedale Metropolitano Niguarda — Milan, MI, Italy (RECRUITING)
- Azienda USL IRCCS di Reggio Emilia — Reggio Emilia, RE, Italy (RECRUITING)
- A.O.S.G. Moscati — Avellino, Italy (RECRUITING)
- Spedali Civili Brescia — Brescia, Italy (RECRUITING)
- Istituto Oncologico Veneto — Padova, Italy (RECRUITING)
- Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello" — Palermo, Italy (RECRUITING)
- Azienda Ospedaliera di Perugia — Perugia, Italy (RECRUITING)
- Ospedale S. Maria della Misericordia, Azienda Ospedaliera di Perugia — Perugia, Italy (RECRUITING)
- AUSL Piacenza — Piacenza, Italy (RECRUITING)
- Azienda Ospedaliera Santa Maria - Terni — Terni, Italy (RECRUITING)
- AOU Città della salute e della Scienza, "Le Molinette" — Torino, Italy (RECRUITING)
- AOU Città della Salute e della Scienza — Torino, Italy (RECRUITING)
Study contacts
- Principal investigator: Luminari Stefano, MD — Azienda USL - IRCCS di Reggio Emilia
- Study coordinator: Attilio Gennaro, Clinical Research Coordinator
- Email: attilio.gennaro@ausl.re.it
- Phone: +39 0522 295175
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: Classical Hodgkin Lymphoma, Classical Hodgkin Lymphoma Recurrent, Classical Hodgkin Lymphoma Refractory, Liquid Biopsy, classical Hodgkin Lymphoma