Extended Follow up of the TARGIT-A Trial

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03501121

Acronym

TARGIT-X

Enrollment

714

Registered

2018-04-18

Start date

2018-08-16

Completion date

2023-01-31

Last updated

2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm Female

Keywords

intra-operative radiation therapy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to No maximum

Healthy volunteers

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* Any patient who has withdrawn consent for further follow-up, or died.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United Kingdom

Contacts

Primary ContactJayant S Vaidya, MBBS MS DNB FRCS PhD

jayantvaidya@gmail.com+44(0)7801418072

Backup ContactNick J Roberts

nick.j.roberts@ucl.ac.uk

Outcome results