Study of Epigenetic and Inflammatory Markers of Accelerated Biological Ageing in the Follow up of Patients With Hodgkin's Lymphoma (MEPI-AGE)

December 30, 2024 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study of Epigenetic and Inflammatory Markers of Accelerated Biological Ageing in the Follow-up of Patients With Hodgkin's Lymphoma in Complete Remission for at Least 2 Years

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero - Universitaria di Bologna
        • Principal Investigator:
          • Pier Luigi Zinzani, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hodgkin lymphoma patients in complete remission for at least two years and newly diagnosed
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

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of senescence markers (CD57, KLRG1,CD62L, CD45RA)
Time Frame: through study completion, an average of 2 year
Determine the biological age of patients
through study completion, an average of 2 year
DNA methylation (methylation rate)
Time Frame: through study completion, an average of 2 year
Determine the biological age of patients
through study completion, an average of 2 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Pier Luigi Zinzani, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2022

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

December 1, 2024

First Submitted That Met QC Criteria

December 30, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 30, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEPI-AGE
  • PR 1/CS/AIL/21 (Other Grant/Funding Number: AIL Bologna ODV)
  • RC-2022-2773333 (Other Grant/Funding Number: Ricerca Corrente 2022-2024 (Ministero della Salute))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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