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

NCT06761274 | Recruiting

• 3 other identifiers: MEPI-AGEPR 1/CS/AIL/21RC-2022-2773333
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Hodgkin Lymphoma in Remission

Keywords

epigenetic markers

Outcome Measures

Primary Outcomes (2)

• evaluation of senescence markers (CD57, KLRG1,CD62L, CD45RA)

  Determine the biological age of patients

  through study completion, an average of 2 year

• DNA methylation (methylation rate)

  Determine the biological age of patients

  through study completion, an average of 2 year

Secondary Outcomes (2)

• evaluation of senescence markers (CD57, KLRG1,CD62L, CD45RA)

  through study completion, an average of 2 year

• DNA methylation (methylation rate)

  through study completion, an average of 2 year

Study Arms (1)

hodgkin lymphoma patients in complete remission for at least two years and newly diagnosed

EXPERIMENTAL

in vitro human tissue testing of peripheral blood in hodgkin lymphoma patients in complete remission for at least two years after first-line therapy with stage II b, III or IV

Other: peripheral blood sampling

Interventions

peripheral blood sampling OTHER

It is a monocentric and exploratory study, experimental on human tissues in vitro and similar projects do not exist in the literature. This study involves the analysis of peripheral blood in patients with hodgkin lymphoma with the following characteristics: * in complete remission for at least two years after first-line therapy with stage II b, III or IV at onset (Ann Arbor classification). * newly diagnosed (stage II b, III or IV, Ann Arbor Classification).

hodgkin lymphoma patients in complete remission for at least two years and newly diagnosed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Concomitant second neoplasm

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Study Officials

• Pier Luigi Zinzani, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pier Luigi Zinzani, MD

CONTACT

+390512144042; pierluigi.zinzani@unibo.it

Cinzia Pellegrini, MD

CONTACT

+390512103680; cinzia.pellegrini@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: January 7, 2025
• Study Start: November 3, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)