TARGeted Intraoperative radioTherapy (TARGIT) Registry Database

NCT ID: NCT02947425

Last Updated: 2019-10-02

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2022-07-31

Brief Summary

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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

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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

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Early-Stage Breast Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Recommended treatment by MDT
* Consent has been obtained to have patient data to be collected

Exclusion Criteria

* Pregnancy (females who have a positive pregnancy test prior to surgery)
* Under 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jayant S Vaidya

Role: PRINCIPAL_INVESTIGATOR

UCL

Locations

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Royal Free Hospital

London, , United Kingdom

Site Status RECRUITING

The London Clinic

London, , United Kingdom

Site Status RECRUITING

Royal Hampshire County Hospital

Winchester, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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United Kingdom

Central Contacts

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Nick J Roberts

Role: CONTACT

Norman Williams, PhD

Role: CONTACT

Facility Contacts

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Norman Williams, PhD

Role: primary

Alistair Gifford-Moore

Role: primary

Siobhan <> Laws, FRCS

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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