TARGeted Intraoperative radioTherapy (TARGIT) Registry Database
NCT ID: NCT02947425
Last Updated: 2019-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2013-07-31
2022-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Consent has been obtained to have patient data to be collected
Exclusion Criteria
* Under 18 years of age
18 Years
ALL
No
Sponsors
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University College, London
OTHER
Responsible Party
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Principal Investigators
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Jayant S Vaidya
Role: PRINCIPAL_INVESTIGATOR
UCL
Locations
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Royal Free Hospital
London, , United Kingdom
The London Clinic
London, , United Kingdom
Royal Hampshire County Hospital
Winchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Alistair Gifford-Moore
Role: primary
Other Identifiers
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ISRCTN91179875
Identifier Type: OTHER
Identifier Source: secondary_id
14/LO/1452
Identifier Type: OTHER
Identifier Source: secondary_id
TARGIT R
Identifier Type: -
Identifier Source: org_study_id
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