Using blood tests to detect residual disease in Hodgkin lymphoma patients
Cell-free Tumor DNA Analysis for Minimal Residual Disease Detection in Patients With Hodgkin Lymphoma
Federico II University · NCT05254821
This study is testing if a blood test that looks for tiny pieces of tumor DNA can help doctors better find leftover cancer in patients with Hodgkin lymphoma after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Federico II University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Naples) |
| Trial ID | NCT05254821 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the use of cell-free tumor DNA (ctDNA) to identify minimal residual disease in patients with Hodgkin lymphoma. By analyzing ctDNA from blood samples, the study aims to improve the accuracy of detecting residual disease compared to traditional imaging methods like FDG-PET. The approach seeks to identify patients who may need intensified treatment or those who could benefit from treatment de-escalation based on their response to chemotherapy. Clinical data and blood samples will be collected at various stages of treatment to monitor changes in ctDNA levels.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a documented diagnosis of Hodgkin lymphoma.
Not a fit: Patients who are not diagnosed with Hodgkin lymphoma or those with an ECOG performance status greater than 3 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment plans for Hodgkin lymphoma patients, improving outcomes by accurately identifying those who need more aggressive therapy.
How similar studies have performed: While the use of ctDNA in other cancers has shown promise, this specific application in Hodgkin lymphoma is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female adults 18 years or older * Documented diagnosis of Hodgkin lymphoma (both classic and nodular predominant lymphocytes subtype) according to 2016 WHO classification * Willing and able to comply with scheduled study procedures * Evidence of a signed informed consent * ECOG performance status 0-2 (or 3, if disease related)
Where this trial is running
Naples
- Federico II University — Naples, Italy (RECRUITING)
Study contacts
- Study coordinator: Claudia Giordano, MD
- Email: claudiagiordano91@hotmail.com
- Phone: 0817464289
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: Hodgkin Lymphoma, ctDNA, Next generation sequencing, Hodgkin lymphoma