Extended Follow up of the TARGIT-A Trial

NCT03501121 | Unknown

• 1 other identifier: 17/0774
• Study Type: observational
• Target: 714
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Neoplasm Female

Keywords

intra-operative radiation therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Long-term follow-up through national registries

  Up to 20 years

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Any patient who has withdrawn consent for further follow-up, or died.

Sponsors & Collaborators

• University College, London: lead

Study Sites (2)

University College London

London, United Kingdom

RECRUITING

Royal Hampshire County Hospital

Winchester, United Kingdom

RECRUITING

Study Officials

• Jayant Vaidya

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jayant S Vaidya, MBBS MS DNB FRCS PhD

CONTACT

+44(0)7801418072; jayantvaidya@gmail.com

Nick J Roberts

CONTACT

nick.j.roberts@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: April 18, 2018
• Study Start: August 16, 2018
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: October 6, 2021

Record last verified: 2021-09

Locations

GB (2)