TARGeted Intraoperative radioTherapy (TARGIT) Registry Database
TARGIT R
TARGIT R: TARGeted Intraoperative radioTherapy (TARGIT) Registry Database
3 other identifiers
observational
2,000
1 country
3
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2013
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 15, 2016
CompletedFirst Posted
Study publicly available on registry
October 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedOctober 2, 2019
October 1, 2019
9 years
August 15, 2016
October 1, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Five years
Secondary Outcomes (1)
Cost effectiveness
Five years
Eligibility Criteria
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.
You may qualify if:
- Recommended treatment by MDT
- Consent has been obtained to have patient data to be collected
You may not qualify if:
- Pregnancy (females who have a positive pregnancy test prior to surgery)
- Under 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Royal Free Hospital
London, United Kingdom
The London Clinic
London, United Kingdom
Royal Hampshire County Hospital
Winchester, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jayant S Vaidya
UCL
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2016
First Posted
October 27, 2016
Study Start
July 1, 2013
Primary Completion
July 1, 2022
Study Completion
July 1, 2022
Last Updated
October 2, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will share
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.