Breast Neoplasm FemaleTARGIT-XNCT03501121
Extended Follow up of the TARGIT-A Trial
An observational study of Breast Neoplasm Female, run by University College, London at 2 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female
- How many people
- 714 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 16 Aug 2018to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients who participated in the TARGIT-A trial (see NCT00983684).
Who may be able to join
- All patients who participated in the TARGIT-A trial (NCT00983684).
Who cannot join
- Any patient who has withdrawn consent for further follow-up, or died.
Trial locations and contacts
2 sites in 1 country.
Nick J Roberts contact
United Kingdom2 sites, 2 recruiting
- Recruiting
University College London
London
Jayant S Vaidya, MBBS MS DNB FRCS PhD
Jayant S Vaidya
- Recruiting
Royal Hampshire County Hospital
Winchester
Siobhan Laws
Siobhan Laws
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start16 Aug 2018
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 714 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayant Vaidya, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501121
- Sponsor's protocol ID
- 17/0774
- Acronym
- TARGIT-X
- Status last verified
- Sep 2021
- First submitted
- 15 Mar 2018
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vaidya 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.
PubMed 42011087
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Follow up of the TARGIT-A Trial
- ClinicalTrials.gov ID
- NCT03501121
- Acronym / sponsor ID
- TARGIT-X / 17/0774
- Conditions
- Breast Neoplasm Female
- Keywords
- intra-operative radiation therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 714 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who participated in the TARGIT-A trial (see NCT00983684).
Key inclusion criteria (1 listed)
- All patients who participated in the TARGIT-A trial (NCT00983684).
Key exclusion criteria (1 listed)
- Any patient who has withdrawn consent for further follow-up, or died.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long-term follow-up through direct patient contact
Time frame: 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.
1 secondary outcome
Long-term follow-up through national registries
Time frame: Up to 20 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Derived from this study: PubMed 42011087Vaidya 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick J Roberts contact
Jayant Vaidya principal investigator
University College, London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasm Female, run by University College, London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jayant S Vaidya, MBBS MS DNB FRCS PhD (+44(0)7801418072, jayantvaidya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term follow-up through direct patient contact (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03501121, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.