Extended follow up of the TARGIT-A trial

ISRCTN	ISRCTN86287193
DOI	https://doi.org/10.1186/ISRCTN86287193
Secondary identifying numbers	37219; HTA 14/49/13

Submission date: 26/03/2018
Registration date: 25/04/2018
Last edited: 20/09/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-radiotherapy-during-surgery-for-early-stage-breast-cancer

Study website

Contact information

Mr Nick Roberts
Scientific

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

Phone	+44 (0)20 7679 9280
Email	ctg.targit@ucl.ac.uk

Study information

Study design	Observational; Design type: Cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Extended follow up of the TARGIT-A trial
Study objectives	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(s)	London - Fulham Research Ethics Committee, 14/03/2018, REC ref: 18/LO/0181
Health condition(s) or problem(s) studied	Breast cancer
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
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 study start date	30/04/2018
Completion date	31/01/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Planned Sample Size: 3451; UK Sample Size: 714
Key inclusion criteria	1. All patients who participated in the TARGIT-A trial 2. Female 3. 45 years and older
Key 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
Date of first enrolment	30/04/2018
Date of final enrolment	31/01/2023

Locations

Countries of recruitment

England
Scotland
United Kingdom

Study participating centres

The Whittington Hospital NHS Trust

St Pancras Way
London
NW1 0PE
United Kingdom

Guy's and St Thomas' NHS Foundation Trust

Great Maze Pond
London
SE1 9RT
United Kingdom

Royal Free London NHS Foundation Trust

Pond Street
London
NW3 2QG
United Kingdom

Ninewells Hospital and Medical School

Dundee
DD1 9SY
United Kingdom

Royal Hampshire County Hospital

Romsey Road
Winchester
SO22 5DG
United Kingdom

University College London Hospitals NHS Foundation Trust

235 Euston Road
London
NW1 2BU
United Kingdom

Sponsor information

University College London
University/education

c/o Tabitha Kavoi
The Joint Research Office
Gower Street
London
WC1E 6BT
England
United Kingdom

Phone	+44 (0)2034475199
Email	Rand.D@uclh.nhs.uk
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

Results and Publications

Intention to publish date	31/01/2024
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
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 plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version v1.0	10/11/2017	26/08/2020	No	No
HRA research summary			28/06/2023	No	No

Additional files

ISRCTN86287193_PROTOCOL_v1.0_10Nov17.pdf: uploaded 26/08/2020

Editorial Notes

20/09/2021: Internal review.
26/08/2020: Uploaded protocol (not peer reviewed) Version 1.0 10 November 2017.
25/03/2019: The condition was updated from "Specialty: Cancer, Primary sub-specialty: Breast Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasm of breast" to "".
06/06/2018: Cancer Research UK lay summary link added to Plain English Summary Field