Lymphoma, Non-HodgkinCardiocareNCT03480087
Subclinical Cardio-toxicities Evaluation With Strain Rate Echocardiography After Chemotherapy and/or Mediastinal Radiotherapy in Patient With Lymphoma
An observational study of Lymphoma, Non-Hodgkin and Hodgkin Lymphoma, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
Treatments-related cardiotoxicity is a critical issue in long term lymphoma survivors, particularly at young age, and its early identification is important to prevent clinically relevant cardiac events. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Hodgkin Lymphoma, Toxicity, Cardiac
- How many people
- 118 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient 19-70 years old with HD or PMBCL or DLBCL requiring treatment with chemotherapy or chemotherapy plus mediastinal radiotherapy suitable for a strain-rate echocardiograpy evaluation
Who may be able to join
- Age >18 years
- Diagnosis of Hodgkin Disease (HD) or Primary Mediastinal B-cell lymphoma (PMBCL) or diffuse large B-cell lymphoma (DLBCL)
- Disease requiring treatment with anthracycline containing regimen only (cohort A) or anthracycline containing regimen followed by mediastinal radiotherapy (cohort B)
- Written informed consent
Who cannot join
- Age > 70 years
- Unable to perform anthracyline containing regimen
- Previous treatment with mediastinal radiotherapy
- Kidney failure (defined as creatinine x2 UNL) or liver failure (defined as AST and ALT x2 UNL)
- ECOG PS > 2
- Echocardiographic acoustic windows not suitable for strain evaluation
- Any other conditions or situations preventing patients to sign informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
SC Ematologia - AOU Città della salute e della Scienza di Torino
Torino, 10126
About this study
Treatments-related cardiotoxicity is a critical issue in long term lymphoma survivors, particularly at young age, and its early identification is important to prevent clinically relevant cardiac events. Complete echocardiographic assessment including 2-dimension global longitudinal strain (2D-GLS), seems to be an effective tools in detecting preclinical systolic changes to the cardiac function even when the ejection fraction is preserved. The aim of Cardiocare study is to investigate early detection of subclinical chemo and radiation-induced changes in left ventricular function using 2D-GLS.
- Conditions
- Lymphoma, Non-Hodgkin, Hodgkin Lymphoma, Toxicity, Cardiac
- Keywords
- strain-rate echocardiography, chemotherapy, radiotherapy, mediastinal, Lymphoma, Hodgkin
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease, Cardiotoxicity, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy alone | Patient treated with anthracycline containing chemotherapy | |
| Chemotherapy plus radiotherapy | Patient treated with anthracycline containing chemotherapy followed by mediastinal radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction (LVEF)
Left ventricular ejection fraction measured by echocardiography
Measured: Baseline, Change of LVEF from Baseline at 4/6 month (end of chemotherapy), Change of LVEF from Baseline at 6/8 months (end of radiotherapy - if applicable), Change of LVEF from Baseline at 9/11 months (3 months after treatment completion)
Global Longitudinal Strain (GLS)
Global Longitudinal Strain measured by strain-rate echocardiography
Measured: Baseline, Change of GLS from Baseline at 4/6 month (end of chemotherapy), Change of GLS from Baseline at 6/8 months (end of radiotherapy - if applicable), Change of GLS from Baseline at 9/11 months (3 months after treatment completion)
Secondary outcomes (2)
Anthracycline cumulative dose
Anthracycline cumulative dose
Measured: 4/6 month after baseline (end of chemotherapy)
T troponin
T troponin rate
Measured: Baseline, Before each chemotherapy administration, 4/6 month after baseline (end of chemotherapy), 6/8 months after baseline (end of radiotherapy - if applicable), 9/11 months after baseline (3 months after treatment completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study startJan 2015
- Primary completionJul 2022
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Levis, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480087
- Sponsor's protocol ID
- Cardiocare
- Acronym
- Cardiocare
- Status last verified
- Jul 2022
- First submitted
- 14 Mar 2018
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subclinical Cardio-toxicities Evaluation With Strain Rate Echocardiography After Chemotherapy and/or Mediastinal Radiotherapy in Patient With Lymphoma
- ClinicalTrials.gov ID
- NCT03480087
- Acronym / sponsor ID
- Cardiocare / Cardiocare
- Conditions
- Lymphoma, Non-Hodgkin, Hodgkin Lymphoma, Toxicity, Cardiac
- Keywords
- strain-rate echocardiography, chemotherapy, radiotherapy, mediastinal, Lymphoma, Hodgkin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jul 2022 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 29 Mar 2018 (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.
Treatments-related cardiotoxicity is a critical issue in long term lymphoma survivors, particularly at young age, and its early identification is important to prevent clinically relevant cardiac events. Complete echocardiographic assessment including 2-dimension global longitudinal strain (2D-GLS), seems to be an effective tools in detecting preclinical systolic changes to the cardiac function even when the ejection fraction is preserved. The aim of Cardiocare study is to investigate early detection of subclinical chemo and radiation-induced changes in left ventricular function using 2D-GLS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy alone | – | –Patient treated with anthracycline containing chemotherapy |
| Chemotherapy plus radiotherapy | – | –Patient treated with anthracycline containing chemotherapy followed by mediastinal radiotherapy |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient 19-70 years old with HD or PMBCL or DLBCL requiring treatment with chemotherapy or chemotherapy plus mediastinal radiotherapy suitable for a strain-rate echocardiograpy evaluation
Key inclusion criteria (4 listed)
- Age >18 years
- Diagnosis of Hodgkin Disease (HD) or Primary Mediastinal B-cell lymphoma (PMBCL) or diffuse large B-cell lymphoma (DLBCL)
- Disease requiring treatment with anthracycline containing regimen only (cohort A) or anthracycline containing regimen followed by mediastinal radiotherapy (cohort B)
- Written informed consent
Key exclusion criteria (7 listed)
- Age > 70 years
- Unable to perform anthracyline containing regimen
- Previous treatment with mediastinal radiotherapy
- Kidney failure (defined as creatinine x2 UNL) or liver failure (defined as AST and ALT x2 UNL)
- ECOG PS > 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Left ventricular ejection fraction (LVEF)
Time frame: Baseline, Change of LVEF from Baseline at 4/6 month (end of chemotherapy), Change of LVEF from Baseline at 6/8 months (end of radiotherapy - if applicable), Change of LVEF from Baseline at 9/11 months (3 months after treatment completion)
Left ventricular ejection fraction measured by echocardiography
Global Longitudinal Strain (GLS)
Time frame: Baseline, Change of GLS from Baseline at 4/6 month (end of chemotherapy), Change of GLS from Baseline at 6/8 months (end of radiotherapy - if applicable), Change of GLS from Baseline at 9/11 months (3 months after treatment completion)
Global Longitudinal Strain measured by strain-rate echocardiography
2 secondary outcomes
Anthracycline cumulative dose
Time frame: 4/6 month after baseline (end of chemotherapy)
T troponin
Time frame: Baseline, Before each chemotherapy administration, 4/6 month after baseline (end of chemotherapy), 6/8 months after baseline (end of radiotherapy - if applicable), 9/11 months after baseline (3 months after treatment completion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Non-Hodgkin and Hodgkin Lymphoma, run by A.O.U. Città della Salute e della Scienza 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 7 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: finished, as of the sponsor's last update on 19 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (LVEF) (time frame: Baseline, Change of LVEF from Baseline at 4/6 month (end of chemotherapy), Change of LVEF from Baseline at 6/8 months (end of radiotherapy - if applicable), Change of LVEF from Baseline at 9/11 months (3 months after treatment completion)). 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 19 Jul 2022.