Breast Cancer Long-term Outcome of Cardiac Dysfunction

NCT01904331 | Completed

• 1 other identifier: 686317
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the prevalence of cardiac dysfunction and (undiagnosed) heart failure in women registered in general practice with a history of breast cancer who received chemotherapy and / or radiotherapy as compared to a matched female control population.

Conditions

Breast Neoplasms

Keywords

Cardiotoxicity; long-term effects; chemotherapy; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Cardiac dysfunction

  systolic and diastolic parameters at time of inclusion

  on average 11 years after treatment with breast cancer

Secondary Outcomes (1)

• Biomarkers +DNA

  on average 11 years after treatment with breast cancer

Other Outcomes (1)

• Clinical complaints and signs at inclusion

  on average 11 years after treatment with breast cancer

Study Arms (2)

Breast cancer patients

Women who were curatively treated with chemo- and/or radiotherapy for breast cancer

Controls

Women matched on age and general practitioner with the breast cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients are selected in primary care practices in the Northern part of the Netherlands. Controls are randomly selected in the same primary care clinics as participants.

You may qualify if:

• For breast cancer patients: minimum of 5 years after treatment for breast cancer with chemo- and/or radiotherapy and after 1970
• For breast cancer patients: younger than 80 at the time of diagnosis of breast cancer
• willing to sign an informed consent

You may not qualify if:

• Treatment with chemo- and/or radiotherapy for other types of cancer besides breast cancer
• women who are unable to participate (e.g. terminally or mentally ill)

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen (UMCG)

Groningen, 9700RB, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

EDTA-plasma, Heparin-Lithium plasma, Serum, Frozen whole blood

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Marjolein Y Berger, M.D. Ph.D.

  University Medical Center Groningen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 22, 2013
• Study Start: June 1, 2013
• Primary Completion: February 6, 2016
• Study Completion: October 24, 2017
• Last Updated: June 15, 2018

Record last verified: 2018-06

Locations

NL (1)