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Clinical Trials/NCT06761274
NCT06761274RecruitingNot Applicable

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

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 site in 1 country200 target enrollmentStarted: November 3, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
200
Locations
1
Primary Endpoint
evaluation of senescence markers (CD57, KLRG1,CD62L, CD45RA)

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: peripheral blood sampling (Other)

Outcomes

Primary Outcomes

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

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

Determine the biological age of patients

DNA methylation (methylation rate)

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

Determine the biological age of patients

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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