Early Assessment of Anthracycline-induced Cardiotoxicity... | NCT00195897

Studies
Early Assessment of Anthracycline-induced Cardiotoxicity (CARDIOTOX)

NCT00195897

Sponsor

Centre Henri Becquerel

Status

Terminated

Last Update Posted

Aug 22, 2016Estimated

Enrollment

6Actual

Phase

Not provided

Conditions

Lymphoma
Heart Failure, Congestive

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patients; only 6 enrolled after 2 years

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2016

Last Update Posted Date

Aug 22, 2016Estimated

Name	Class
Ligue contre le cancer, France	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Hodgkin lymphoma disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alain Manrique, MD	Centre Henri Becquerel	Study Chair
Fabrice Jardin, MD	Centre Henri Becquerel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Rouen		Rouen		76031	France
Centre Henri Becquerel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12075738	Background	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.
9744975	Background	Singal PK, Iliskovic N. Doxorubicin-induced cardiomyopathy. N Engl J Med. 1998 Sep 24;339(13):900-5. doi: 10.1056/NEJM199809243391307. No abstract available.

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

ID	Term
D008223	Lymphoma
D006333	Heart Failure