Extended Follow up of the TARGIT-A Trial

Breast Neoplasm Female Clinical Trial

— TARGIT-X  

Official title:

Extended Follow up of the TARGIT-A Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03501121
• Other study ID #: 17/0774
• Status: Recruiting
• Start date: August 16, 2018
• Est. completion date: January 31, 2023

Study information

• Verified date: September 2021
• Source: University College, London
• Contact: Jayant S Vaidya, MBBS MS DNB FRCS PhD
• Phone: +44(0)7801418072
• Email: jayantvaidya[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 714
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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• Any patient who has withdrawn consent for further follow-up, or died.

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms

Locations

Country	Name	City	State
United Kingdom	University College London	London
United Kingdom	Royal Hampshire County Hospital	Winchester

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term follow-up through direct patient contact	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.	60 months
Secondary	Long-term follow-up through national registries	Collect death & new primary cancer data from UK patients through the Office for National Statistics.	Up to 20 years