Early-Stage Breast CarcinomaTARGIT RNCT02947425
TARGeted Intraoperative radioTherapy (TARGIT) Registry Database
An observational study of Early-Stage Breast Carcinoma, run by University College, London at 3 sites in United Kingdom.
Trial summary
This is a prospectively registered database of patients with early breast cancer who will be treated with radiotherapy during surgery. More than 2000 women have already received this treatment in clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early-Stage Breast Carcinoma
- How many people
- 2,000 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jul 2013to Jul 2022
- How long will I take part?
- 10 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population is very wide, reflecting the pragmatic nature of this study. There will be few inclusion and exclusion criteria. Basically, any person aged over 18 with early breast cancer suitable for breast conserving surgery will be eligible. More specific entry criteria for those aged 45 or less will be defined by a participating institution's multidisciplinary team. Experience to date has indicated that there are many patients who are deemed unsuitable for a course of external beam radiotherapy whose only option is therefore mastectomy; such situations can be difficult to define in advance, and should be decided on a case-by-case basis.
Who may be able to join
- Recommended treatment by MDT
- Consent has been obtained to have patient data to be collected
Who cannot join
- Pregnancy (females who have a positive pregnancy test prior to surgery)
- Under 18 years of age
Trial locations and contacts
3 sites in 1 country.
Nick J Roberts contact
Norman Williams, PhD contact
United Kingdom3 sites, 3 recruiting
- Recruiting
Royal Free Hospital
London
Norman Williams, PhD, SITU.TARGITR@ucl.ac.uk
Sarah Needleman
- Recruiting
The London Clinic
London
Alistair Gifford-Moore
Gerald Gui
- Not yet recruiting
Royal Hampshire County Hospital
Winchester
Siobhan <> Laws, FRCS, Siobhan.Laws@hhft.nhs.uk
Dick Rainsbury, FRCS
About this study
Official title: TARGIT R: TARGeted Intraoperative radioTherapy (TARGIT) Registry Database
This is a prospectively registered database of patients with early breast cancer who will be treated with radiotherapy during surgery. More than 2000 women have already received this treatment in clinical trials. This study will monitor the health status of women who receive this treatment outside of a clinical trial, especially those who might not have been eligible for the original clinical trials. The aim is to confirm the long-term effectiveness and safety of the technique.
Read the detailed description
Registration of patients selected for this treatment; collecting data regarding safety and toxicity on patients who have had treatment with TARGIT.
Outcomes will be measured over short and long terms. Outcome measures will include effectiveness and safety, assessed in various cohorts of patients. Core outcomes will be used for effectiveness. In addition, true recurrence (basically, ipsilateral breast tumor recurrence at the same site as the original primary) will be used as defined by Recht. Safety outcomes will be based on Common Toxicity Criteria.
Budget impact analysis of IORT in subgroups of patients will be assessed. This amounts to using cost data to calculate the mean incremental (or extra) cost per person treated using intraoperative radiotherapy (IORT) versus external beam radiotherapy (EBRT) and mastectomies (where IORT could have been given instead) and then multiplying this by the total patients eligible nationally for IORT, to calculate the total expected budget impact on the NHS if IORT in these subgroups was rolled out nationally.
- Conditions
- Early-Stage Breast Carcinoma
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumour control (defined as no recurrent tumour in the ipsilateral breast)
Confirmation that the TARGIT technique results in an acceptably low rate of local recurrence when given outside of a randomised controlled trial.
Measured: Five years
Adverse events related to the primary treatment of the breast cancer.
Confirmation that the TARGIT technique results in an acceptably low rate of safety events assessed by CTCAE v4.0 when given outside of a randomised controlled trial.
Measured: Five years
Secondary outcomes (1)
Cost effectiveness
Confirmation that the TARGIT technique is cost-effective as assessed by both health related quality of life (EQ5D) and cost data.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startJul 2013
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-Stage Breast CarcinomaStudies 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
- 2,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayant S Vaidya, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947425
- Sponsor's protocol ID
- TARGIT R
- Other IDs
- ISRCTN91179875, 14/LO/1452
- Acronym
- TARGIT R
- Status last verified
- Oct 2019
- First submitted
- 15 Aug 2016
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: All requests for data sharing will adhere to the UCL Surgical \& Interventional Trials Unit (SITU) data sharing agreement policy. UCL Medical School is supportive of data sharing and will endeavour to assist in requests for data sharing. These data will be held at UCL on secure servers and will not be released to any third parties until the final study report has been published. All requests for access to the data will be formally requested through the use of a SITU data request form which will state the purpose, analysis and publication plans together with the named collaborators. All requests are dealt with on a case by case basis. All requests will be logged and those successful will have a data transfer agreement which will specify appropriate acknowledgement of the Royal Free Hospital, the sponsor, and funders.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TARGIT R: TARGeted Intraoperative radioTherapy (TARGIT) Registry Database
- ClinicalTrials.gov ID
- NCT02947425
- Acronym / sponsor ID
- TARGIT R / TARGIT R
- Conditions
- Early-Stage Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 27 Oct 2016 (estimated)
- 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.
This is a prospectively registered database of patients with early breast cancer who will be treated with radiotherapy during surgery. More than 2000 women have already received this treatment in clinical trials. This study will monitor the health status of women who receive this treatment outside of a clinical trial, especially those who might not have been eligible for the original clinical trials. The aim is to confirm the long-term effectiveness and safety of the technique.
Detailed description
Registration of patients selected for this treatment; collecting data regarding safety and toxicity on patients who have had treatment with TARGIT.
Outcomes will be measured over short and long terms. Outcome measures will include effectiveness and safety, assessed in various cohorts of patients. Core outcomes will be used for effectiveness. In addition, true recurrence (basically, ipsilateral breast tumor recurrence at the same site as the original primary) will be used as defined by Recht. Safety outcomes will be based on Common Toxicity Criteria.
Budget impact analysis of IORT in subgroups of patients will be assessed. This amounts to using cost data to calculate the mean incremental (or extra) cost per person treated using intraoperative radiotherapy (IORT) versus external beam radiotherapy (EBRT) and mastectomies (where IORT could have been given instead) and then multiplying this by the total patients eligible nationally for IORT, to calculate the total expected budget impact on the NHS if IORT in these subgroups was rolled out nationally.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population is very wide, reflecting the pragmatic nature of this study. There will be few inclusion and exclusion criteria. Basically, any person aged over 18 with early breast cancer suitable for breast conserving surgery will be eligible. More specific entry criteria for those aged 45 or less will be defined by a participating institution's multidisciplinary team. Experience to date has indicated that there are many patients who are deemed unsuitable for a course of external beam radiotherapy whose only option is therefore mastectomy; such situations can be difficult to define in advance, and should be decided on a case-by-case basis.
Key inclusion criteria (2 listed)
- Recommended treatment by MDT
- Consent has been obtained to have patient data to be collected
Key exclusion criteria (2 listed)
- Pregnancy (females who have a positive pregnancy test prior to surgery)
- Under 18 years of age
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
Local tumour control (defined as no recurrent tumour in the ipsilateral breast)
Time frame: Five years
Confirmation that the TARGIT technique results in an acceptably low rate of local recurrence when given outside of a randomised controlled trial.
Adverse events related to the primary treatment of the breast cancer.
Time frame: Five years
Confirmation that the TARGIT technique results in an acceptably low rate of safety events assessed by CTCAE v4.0 when given outside of a randomised controlled trial.
1 secondary outcome
Cost effectiveness
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: Yes. All requests for data sharing will adhere to the UCL Surgical \& Interventional Trials Unit (SITU) data sharing agreement policy. UCL Medical School is supportive of data sharing and will endeavour to assist in requests for data sharing. These data will be held at UCL on secure servers and will not be released to any third parties until the final study report has been published. All requests for access to the data will be formally requested through the use of a SITU data request form which will state the purpose, analysis and publication plans together with the named collaborators. All requests are dealt with on a case by case basis. All requests will be logged and those successful will have a data transfer agreement which will specify appropriate acknowledgement of the Royal Free Hospital, the sponsor, and funders.
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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
Norman Williams, PhD contact
Jayant S Vaidya principal investigator
UCL
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early-Stage Breast Carcinoma, run by University College, London at 3 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 2 inclusion and 2 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 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Nick J Roberts (SITU.TARGITR@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tumour control (defined as no recurrent tumour in the ipsilateral breast) (time frame: Five years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2019.