LymphomaNCT00195897
Early Assessment of Anthracycline-induced Cardiotoxicity (CARDIOTOX)
An observational study of Lymphoma and Heart Failure, Congestive, run by Centre Henri Becquerel at 2 sites in France.
Trial summary
Anthracycline-based chemotherapy is a key point of the treatment of patients with Hodgkin's and non-Hodgkin's lymphomas. However, cumulative doses are limited by cardiotoxicity, resulting in a marked left ventricular function impairment that may lead to heart failure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphoma, Heart Failure, Congestive
- How many people
- 6 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2006to Dec 2009
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hodgkin lymphoma disease
Who may be able to join
- Histologically proven lymphoma (Hodgkin's or non-Hodgkin's)
- Age > 18 y/o and < 70 y/o
- WHO score < or = 2
- Life expectancy > 6 mo
- Left ventricular ejection fraction > 50%
- Informed consent
Who cannot join
- Previous chemotherapy using anthracyclines
- History of radiation therapy
- History of congestive heart failure
- History of chronic renal insufficiency
- Contra indication to MR examination
- Atrial fibrillation and significant arrhythmia
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital of Rouen
Rouen, 76031
Centre Henri Becquerel
Rouen, 76038
About this study
Official title: Early Assessment of Anthracycline-induced Cardiotoxicity: Usefulness of Biochemical Markers and Ventricular Function Assessment.
Anthracycline-based chemotherapy is a key point of the treatment of patients with Hodgkin's and non-Hodgkin's lymphomas. However, cumulative doses are limited by cardiotoxicity, resulting in a marked left ventricular function impairment that may lead to heart failure.
The standard clinical approach to monitoring for anthracycline cardiotoxicity is based on cardiac function monitoring using echocardiography or radionuclide angiography. The aim of this study is to evaluate the usefulness of biochemical markers of cardiac injury (troponin and NT-proBNP) and structural changes on cardiac MR in predicting anthracycline cardiotoxicity.
- Conditions
- Lymphoma, Heart Failure, Congestive
- Keywords
- Lymphoma, Anthracyclines, Heart Failure, Radionuclide, Magnetic Resonance Imaging, Troponin, Natriuretic Peptide, Brain
- Medical subject headings
- Lymphoma, Heart Failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2006
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: No patients; only 6 enrolled after 2 years
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Responsible party
- Sponsor
- Investigators
- Alain Manrique, MD, Study chair, Centre Henri BecquerelFabrice Jardin, MD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195897
- Sponsor's protocol ID
- 2005-001-CHB
- Status last verified
- Aug 2016
- First submitted
- 12 Sep 2005
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cardinale D, Sandri MT, Martinoni A, Borghini E, Civelli M, Lamantia G, Cinieri S, Martinelli G, Fiorentini C, Cipolla CM. Myocardial injury revealed by plasma troponin I in breast cancer treated with high-dose chemotherapy. Ann Oncol. 2002 May;13(5):710-5. doi: 10.1093/annonc/mdf170.
PubMed 12075738Singal PK, Iliskovic N. Doxorubicin-induced cardiomyopathy. N Engl J Med. 1998 Sep 24;339(13):900-5. doi: 10.1056/NEJM199809243391307. No abstract available.
PubMed 9744975Okumura H, Iuchi K, Yoshida T, Nakamura S, Takeshima M, Takamatsu H, Ikeno A, Usuda K, Ishikawa T, Ohtake S, Matsuda T. Brain natriuretic peptide is a predictor of anthracycline-induced cardiotoxicity. Acta Haematol. 2000;104(4):158-63. doi: 10.1159/000046508.
PubMed 11279304Mitani I, Jain D, Joska TM, Burtness B, Zaret BL. Doxorubicin cardiotoxicity: prevention of congestive heart failure with serial cardiac function monitoring with equilibrium radionuclide angiocardiography in the current era. J Nucl Cardiol. 2003 Mar-Apr;10(2):132-9. doi: 10.1067/mnc.2003.7.
PubMed 12673177
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Assessment of Anthracycline-induced Cardiotoxicity: Usefulness of Biochemical Markers and Ventricular Function Assessment.
- ClinicalTrials.gov ID
- NCT00195897
- Acronym / sponsor ID
- 2005-001-CHB
- Conditions
- Lymphoma, Heart Failure, Congestive
- Keywords
- Lymphoma, Anthracyclines, Heart Failure, Radionuclide, Magnetic Resonance Imaging, Troponin, Natriuretic Peptide, Brain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No patients; only 6 enrolled after 2 years
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Study start
- Jan 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Sep 2005 (estimated)
- 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.
Anthracycline-based chemotherapy is a key point of the treatment of patients with Hodgkin's and non-Hodgkin's lymphomas. However, cumulative doses are limited by cardiotoxicity, resulting in a marked left ventricular function impairment that may lead to heart failure.
The standard clinical approach to monitoring for anthracycline cardiotoxicity is based on cardiac function monitoring using echocardiography or radionuclide angiography. The aim of this study is to evaluate the usefulness of biochemical markers of cardiac injury (troponin and NT-proBNP) and structural changes on cardiac MR in predicting anthracycline cardiotoxicity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hodgkin lymphoma disease
Key inclusion criteria (6 listed)
- Histologically proven lymphoma (Hodgkin's or non-Hodgkin's)
- Age > 18 y/o and < 70 y/o
- WHO score < or = 2
- Life expectancy > 6 mo
- Left ventricular ejection fraction > 50%
Key exclusion criteria (7 listed)
- Previous chemotherapy using anthracyclines
- History of radiation therapy
- History of congestive heart failure
- History of chronic renal insufficiency
- Contra indication to MR examination
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: No patients; only 6 enrolled after 2 years). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
- Background: PubMed 12075738Cardinale D, Sandri MT, Martinoni A, Borghini E, Civelli M, Lamantia G, Cinieri S, Martinelli G, Fiorentini C, Cipolla CM. Myocardial injury revealed by plasma troponin I in breast cancer treated with high-dose chemotherapy. Ann Oncol. 2002 May;13(5):710-5. doi: 10.1093/annonc/mdf170.
- Background: PubMed 9744975Singal PK, Iliskovic N. Doxorubicin-induced cardiomyopathy. N Engl J Med. 1998 Sep 24;339(13):900-5. doi: 10.1056/NEJM199809243391307. No abstract available.
- Background: PubMed 11279304Okumura H, Iuchi K, Yoshida T, Nakamura S, Takeshima M, Takamatsu H, Ikeno A, Usuda K, Ishikawa T, Ohtake S, Matsuda T. Brain natriuretic peptide is a predictor of anthracycline-induced cardiotoxicity. Acta Haematol. 2000;104(4):158-63. doi: 10.1159/000046508.
- Background: PubMed 12673177Mitani I, Jain D, Joska TM, Burtness B, Zaret BL. Doxorubicin cardiotoxicity: prevention of congestive heart failure with serial cardiac function monitoring with equilibrium radionuclide angiocardiography in the current era. J Nucl Cardiol. 2003 Mar-Apr;10(2):132-9. doi: 10.1067/mnc.2003.7.
- 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. This study is not recruiting at the moment.
Alain Manrique, MD study chair
Centre Henri Becquerel
Fabrice Jardin, MD principal investigator
Centre Henri Becquerel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Heart Failure, Congestive, run by Centre Henri Becquerel at 2 sites in France.
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 6 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: stopped early, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 was stopped early (reason given: No patients; only 6 enrolled after 2 years). Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00195897, which also lists 4 linked publications.
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 22 Aug 2016.