Study of Epigenetic and Inflammatory Markers of Accelerated Biological Ageing in the Follow up of Patients With Hodgkin's Lymphoma

Not Applicable

Recruiting

• Conditions: Hodgkin Lymphoma in Remission

• Registration Number: NCT06761274
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

Study design: It is a monocentric and exploratory study, experimental on human tissues in vitro which involves the analysis of peripheral blood in patients with Hodgkin's lymphomas with the following characteristics:

* in complete remission for at least two years after first-line therapy with stage IIb, III or IV at onset (Ann Arbor classification).

* newly diagnosed (stage IIb, III or IV, Ann Arbor Classification).

Detailed Description

The study aims to evaluate patients with hodgkin lymphoma in complete remission for at least 2 years and newly diagnosed (stage II b, stage III or stage IV) as they are currently characterised by a long life expectancy during which there is an increased and early incidence of non-neoplastic systemic complications as well as, of course, manifestations of secondary malignancies.

Study Timeline

• Study Start: 2022-11-03
• Status Verified: 2024-12
• Study First Submitted: 2024-12-01
• Study First Submitted QC: 2024-12-30
• Last Update Submitted: 2024-12-30
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• hodgkin lymphoma stage II b, III or IV at onset in remission for at least two years after the first line of therapy for lymphoma
• Newly diagnosed histologically confirmed stage II b, III or IV patients who require first-line therapy
• Patients of both sexes aged ≥ 18 years at enrollment
• Signature of informed consent

Exclusion Criteria

• Concomitant second neoplasm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
evaluation of senescence markers (CD57, KLRG1,CD62L, CD45RA)	through study completion, an average of 2 year	Determine the biological age of patients
DNA methylation (methylation rate)	through study completion, an average of 2 year	Determine the biological age of patients

Secondary Outcome Measures

Name	Time	Method
DNA methylation (methylation rate)	through study completion, an average of 2 year	Determine the possible acceleration of the biological age of patients
evaluation of senescence markers (CD57, KLRG1,CD62L, CD45RA)	through study completion, an average of 2 year	Determine the possible acceleration of the biological age of patients

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna; 🇮🇹 Bologna, Italy