Clinical trial · Observational
Extended Follow up of the TARGIT-A Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm Female | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Long-term follow-up through direct patient contact
- timeFrame
- 60 months
- description
- 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 outcomes (1)
- measure
- Long-term follow-up through national registries
- timeFrame
- Up to 20 years
- description
- Collect death \& new primary cancer data from UK patients through the Office for National Statistics.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDVaidya JS, Williams NR, Bulsara M, Brew-Graves C, Potyka I, Roberts N, Lindsay J, Laws S, Raj S, Douek M, Falzon M, Petralia G, Needleman S, Malhotra A, Bernstein M, Tobias JS. A novel methodology using direct patient contact and UK national registries to collect long-term data from randomised trials: TARGIT-X - an extended follow-up study of the TARGIT-A trial of targeted intraoperative radiotherapy for breast cancer. Health Technol Assess. 2026 Apr;30(29):1-32. doi: 10.3310/GJJV2820. PMID 42011087