Condition category
Cancer
Date applied
26/03/2018
Date assigned
25/04/2018
Last edited
06/06/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Mr Nick Roberts

ORCID ID

Contact details

Surgical & Interventional Trials Unit (SITU)
Division of Surgery & Interventional Science
Faculty of Medical Sciences| University College London
Charles Bell House (3rd Floor)
43-45 Foley Street
London
W1W 7JN
United Kingdom
+44 (0)20 7679 9280
ctg.targit@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

37219; HTA 14/49/13

Study information

Scientific title

Extended follow up of the TARGIT-A trial

Acronym

Study hypothesis

All UK patients who participated in the TARGIT-A Trial (https://www.isrctn.com/ISRCTN34086741) 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.

The trialists would like to continue to collect data about the health status of all patients to find out 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 further funding.

Ethics approval

London - Fulham Research Ethics Committee, 14/03/2018, REC ref: 18/LO/0181

Study design

Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Cancer, Primary sub-specialty: Breast Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasm of breast

Intervention

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. Data is collected about the health status of all patients to find out about longer term differences in the effects of these treatments on health. Patients are followed up through direct patient contact for 60 months and through national registries for up to 20 years.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Self-reported health status through direct patient contact [Time Frame: 60 months]

Secondary outcome measures

Death and new primary cancer data from UK patients, collected through the Office for National Statistics [Time Frame: Up to 20 years]

Overall trial start date

30/04/2018

Overall trial end date

31/01/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. All patients who participated in the TARGIT-A trial
2. Female
3. 45 years and older

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 3451; UK Sample Size: 714

Participant exclusion criteria

1. Any patient who has withdrawn consent for further follow-up, or died
2. Any patient who is unable to give formal written consent

Recruitment start date

30/04/2018

Recruitment end date

31/01/2023

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Whittington Hospital NHS Trust
St Pancras Way
London
NW1 0PE
United Kingdom

Trial participating centre

Guy's and St Thomas' NHS Foundation Trust
Great Maze Pond
London
SE1 9RT
United Kingdom

Trial participating centre

Royal Free London NHS Foundation Trust
Pond Street
London
NW3 2QG
United Kingdom

Trial participating centre

Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Trial participating centre

Royal Hampshire County Hospital
Romsey Road
Winchester
SO22 5DG
United Kingdom

Trial participating centre

University College London Hospitals NHS Foundation Trust
235 Euston Road
London
NW1 2BU
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

c/o Tabitha Kavoi
The Joint Research Office
Gower Street
London
WC1E 6BT
United Kingdom
+44 (0)2034475199
Rand.D@uclh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

A draft protocol for publication is in process. Planning to submit and publish protocol to open access journal of which details will be supplied once accepted. Planned publication of the study results in a high-impact peer reviewed journal

IPD sharing statement
All data obtained will be held securely in UCL. Patient identifiers (such as name, address, etc.) will be held on a separate Data Safe Haven which has been certified to the ISO27001 information security standard and conforms to NHS Digital's Information Governance Toolkit. This has been built using a walled garden approach, where the data is stored, processed and managed within the security of the system, avoiding the complexity of assured end point encryption. A file transfer mechanism enables information to be transferred into the walled garden simply and securely. Long term arrangements will be as per the sponsors SOP. On publication of the final analysis and closure of all sites, the main REC (HRA) will be notified using the appropriate forms. All essential documentation, CRFs and electronic records will be catalogued and boxed up. All duplicates and non-essential documentation will be confidentially destroyed. These boxes will be held off site within UCL's commercial storage, provided by Iron Mountain. These data will be held for 20 years, at the end of which they will also be confidentially destroyed.

Intention to publish date

31/01/2024

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/06/2018: Cancer Research UK lay summary link added to Plain English Summary Field