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Status unknownNCT03501121TARGIT-XUpdated Oct 6, 2021

Extended Follow up of the TARGIT-A Trial

An observational study in Breast Neoplasm Female, sponsored by University College, London. Status unknown at 2 sites in United Kingdom. Open to female participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2021-10-06.

Sponsored by University College, London · Observational

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
714
Ages
45 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Breast Neoplasm Female

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Keywords

  • intra-operative radiation therapy
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 714 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Any patient who has withdrawn consent for further follow-up, or died.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

Observational model
Cohort
Time perspective
Prospective
Enrollment
714 participants (estimated)
Patient registry
No
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What researchers measure

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.

    Time frame: 60 months

Secondary outcomes

  1. Long-term follow-up through national registries

    Collect death \& new primary cancer data from UK patients through the Office for National Statistics.

    Time frame: Up to 20 years

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Study locations

2 of 2 sites recruiting
  • University College London
    London, United Kingdom
    • Jayant S Vaidya, MBBS MS DNB FRCS PhD · Contact
    • Jayant S Vaidya · Principal investigator
    Recruiting
  • Royal Hampshire County Hospital
    Winchester, United Kingdom
    • Siobhan Laws · Contact
    • Siobhan Laws · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03501121
Lead sponsor
University College, London
Responsible party
Sponsor
First posted
Apr 18, 2018
Start date
Aug 16, 2018
Primary completion
Jan 31, 2023 (estimated)
Completion
Jan 31, 2023 (estimated)
Last update
Oct 6, 2021

Study contacts

Jayant S Vaidya, MBBS MS DNB FRCS PhD
Contact
jayantvaidya@gmail.com
+44(0)7801418072
Nick J Roberts
Contact
nick.j.roberts@ucl.ac.uk
Jayant Vaidya
principal investigator · University College, London

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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