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NCT Number: NCT06761274

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

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).

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Key information

Conditions

Hodgkin Lymphoma in Remission

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. evaluation of senescence markers (CD57, KLRG1,CD62L, CD45RA)

    Time frame: through study completion, an average of 2 year

    Determine the biological age of patients

  2. DNA methylation (methylation rate)

    Time frame: through study completion, an average of 2 year

    Determine the biological age of patients

Secondary outcomes

  1. 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

  2. DNA methylation (methylation rate)

    Time frame: through study completion, an average of 2 year

    Determine the possible acceleration of the biological age of patients

Study contacts

Contact information is provided by the study sponsor or research team.

Cinzia Pellegrini, MD

CONTACT

[email protected]

+390512103680

Pier Luigi Zinzani, MD

CONTACT

[email protected]

+390512144042

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: MEPI-AGE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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