Extended Follow up of the TARGIT-A Trial (TARGIT-X)

September 28, 2021 updated by: University College, London
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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

714

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • University College London
        • Contact:
          • Jayant S Vaidya, MBBS MS DNB FRCS PhD
        • Principal Investigator:
          • Jayant S Vaidya
      • Winchester, United Kingdom
        • Recruiting
        • Royal Hampshire County Hospital
        • Contact:
          • Siobhan Laws
        • Principal Investigator:
          • Siobhan Laws

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All patients who participated in the TARGIT-A trial (see NCT00983684).

Description

Inclusion Criteria:

  • All patients who participated in the TARGIT-A trial (NCT00983684).

Exclusion Criteria:

  • Any patient who has withdrawn consent for further follow-up, or died.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term follow-up through national registries
Time Frame: Up to 20 years
Collect death & new primary cancer data from UK patients through the Office for National Statistics.
Up to 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Principal Investigator: Jayant Vaidya, University College, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2018

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17/0774

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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