NCT01415999

Brief Summary

Anthracyclines have been used commonly to treat children with solid tumours and haematological malignancies and have led to their increased survival. Nonetheless, anthracycline has the side effect of cardiotoxicity. The purpose of this study is to assess the impact of anthracycline therapy on heart deformation and fibrosis, heart-vessel interaction, usefulness of circulating biomarkers in the assessment of heart function and potential genetic predisposition to heart failure in adult survivors of childhood cancers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

11 months

First QC Date

August 10, 2011

Last Update Submit

October 24, 2017

Conditions

Keywords

anthracyclinecardiac functionechocardiographybiomarkers

Study Arms (2)

patient

adult survivors of childhood malignancies

control

healthy age-matched individuals

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients will be recruited from the 5 public hospitals in Hong Kong (Prince of Wales Hospital, Princess Margaret Hospital, Queen Elizabeth Hospital, Queen Mary Hospital, and Tuen Mun Hospital) that treat the vast majority of childhood cancers, with the number of patients recruited from each hospital proportional to the respective new case-loads in the past 10 years.

You may qualify if:

  • patients aged 18 to 35 years old
  • history of acute leukaemia diagnosed before 18 years old
  • completion of cancer directed therapy for at least 5 years.

You may not qualify if:

  • history of congenital heart disease
  • presence of syndromal disorder such as Down syndrome, neurofibromatosis, etc,
  • hypothyroidism not on replacement therapy
  • claustrophobia or other reasons rendering MRI assessment not feasible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum

Study Officials

  • Yiu-fai Cheung, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 12, 2011

Study Start

August 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

October 25, 2017

Record last verified: 2017-10

Locations