Extended Follow up of the TARGIT-A Trial

• Conditions: Breast Neoplasm Female

• Registration Number: NCT03501121
• Lead Sponsor: University College, London

Brief Summary

All UK patients who participated in the TARGIT-A Trial were initially treated for early breast cancer between 2000-2012. A total of 3451 patients from 33 hospitals in 11 countries participated in the trial and a comparison was made between traditional radiotherapy given over several weeks (external beam radiotherapy, EBRT) with TARGeted Intraoperative radioTherapy (TARGIT-IORT) as a single dose given during the operation to remove the breast cancer. The trial was funded by the Health Technology Assessment (HTA) programme of the Department of Health, UK and sponsored by University College London. The results from this trial have been published in major medical journals and have already started changing the way breast cancer in treated around the world; please see www.targit.org.uk for more details. We would like to continue to collect data about the health status of all patients to enable us to learn about longer term differences in the effects of these treatments on health. An analysis of this information could improve treatment for patients with breast cancer. For this, HTA have granted us further funding.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-04-09
• Study First Posted: 2018-04-18
• Study Start: 2018-08-16
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-10-06
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 714

Inclusion Criteria

• All patients who participated in the TARGIT-A trial (NCT00983684).

Exclusion Criteria

• Any patient who has withdrawn consent for further follow-up, or died.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long-term follow-up through direct patient contact	60 months	Maintaining regular contact with subjects to obtain self-reported health status in order to collect long-term follow-up of patients participating in the TARGIT A Trial.

Secondary Outcome Measures

Name	Time	Method
Long-term follow-up through national registries	Up to 20 years	Collect death \& new primary cancer data from UK patients through the Office for National Statistics.

Trial Locations

Locations (2)

University College London; 🇬🇧 London, United Kingdom

Royal Hampshire County Hospital; 🇬🇧 Winchester, United Kingdom