Hodgkin Lymphoma in RemissionMEPI-AGENCT06761274
Study of Epigenetic and Inflammatory Markers of Accelerated Biological Ageing in the Follow up of Patients With Hodgkin's Lymphoma
A study testing peripheral blood sampling in people with Hodgkin Lymphoma in Remission, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma in Remission
- What is being tested?
- peripheral blood sampling
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 3 Nov 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Concomitant second neoplasm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, 40138
Pier Luigi Zinzani, MD, +390512144042, pierluigi.zinzani@unibo.it
Cinzia Pellegrini, MD, +390512143680, cinzia.pellegrini@aosp.bo.it
About this study
Official 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
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).
Read the 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.
- Conditions
- Hodgkin Lymphoma in Remission
- Being tested
- peripheral blood sampling
- Keywords
- epigenetic markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral blood samplingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: peripheral blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of senescence markers (CD57, KLRG1,CD62L, CD45RA)
Determine the biological age of patients
Measured: through study completion, an average of 2 year
DNA methylation (methylation rate)
Determine the biological age of patients
Measured: through study completion, an average of 2 year
Secondary outcomes (2)
evaluation of senescence markers (CD57, KLRG1,CD62L, CD45RA)
Determine the possible acceleration of the biological age of patients
Measured: through study completion, an average of 2 year
DNA methylation (methylation rate)
Determine the possible acceleration of the biological age of patients
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start3 Nov 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin Lymphoma in RemissionStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pier Luigi Zinzani, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761274
- Sponsor's protocol ID
- MEPI-AGE
- Other IDs
- PR 1/CS/AIL/21, RC-2022-2773333
- Acronym
- MEPI-AGE
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06761274
- Acronym / sponsor ID
- MEPI-AGE / MEPI-AGE
- Conditions
- Hodgkin Lymphoma in Remission
- Keywords
- epigenetic markers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hodgkin lymphoma patients in complete remission for at least two years and newly diagnosed | Experimental | Other: peripheral blood samplingin 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Concomitant second neoplasm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peripheral blood samplingIt 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). | Other | hodgkin lymphoma patients in complete remission for at least two years and newly diagnosed |
Primary outcome
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
2 secondary outcomes
evaluation of senescence markers (CD57, KLRG1,CD62L, CD45RA)
Time frame: through study completion, an average of 2 year
DNA methylation (methylation rate)
Time frame: through study completion, an average of 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pier Luigi Zinzani, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peripheral blood sampling in people with Hodgkin Lymphoma in Remission, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pier Luigi Zinzani, MD (+390512144042, pierluigi.zinzani@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of senescence markers (CD57, KLRG1,CD62L, CD45RA) (time frame: through study completion, an average of 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.