Duct endoscopy in the evaluation of breast cancer and surgical margins

ISRCTN	ISRCTN82827389
DOI	https://doi.org/10.1186/ISRCTN82827389
Secondary identifying numbers	N0258175369

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 15/03/2017

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

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-checking-inside-the-breast-ducts-for-cancer-cells-during-surgery-intend-1

Contact information

Mr Gerald Gui
Scientific

Breast Diagnostic Unit
Royal Marsden NHS Trust
Fulham Road
London
SW3 6JJ
United Kingdom

Phone	+44 (0)20 7487 5558
Email	gerald.gui@rmh.nhs.uk

Study information

Study design	Randomised non-blinded phase III trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Duct endoscopy in the evaluation of breast cancer and surgical margins
Study acronym	INTEND I (intraoperative endoscopic evaluation of duct epithelium)
Study objectives	This project seeks to clarify the future role of breast duct endoscopy versus no duct endoscopy as an adjunct to surgery in a randomised controlled trial. The procedure enables cancer duct systems to be directly visualised. We will test an observation that the re-operation rate for margins involved by cancer can be reduced by inspection of the ducts at the time of surgery. We intend to evaluate the feasibility of this approach by assessing whether the ducts that yield fluid, that can be accessed, have an anatomic relationship with the tumour position. On 17/02/2011 the following changes were made to the trial record: 1. The anticipated end date for this trial was changed from 31/12/2009 to 31/08/2011. 2. The target number of participants was changed from 150 to 176.
Ethics approval(s)	Royal Marsden REC at South London REC Office, St George's University of London, 20/03/2006, ref: 06/Q0801/17
Health condition(s) or problem(s) studied	Cancer: Breast
Intervention	Test intervention vs standardized intervention
Intervention type	Other
Primary outcome measure	Duct endoscopy assisted determination of excision margins in breast conservation surgery and its effect on re-excision rates.
Secondary outcome measures	Added September 2008: laboratory studies on the ductal lavage material obtained.
Overall study start date	09/02/2006
Completion date	31/08/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	176
Key inclusion criteria	1. Female patients undergoing wide local excision determined by standard criteria for the management of needle biopsy-diagnosed DCIS, or clinical stage 1 or 2 breast cancer 2. Tumour <3cm, have not had previous periareolar incisions or surgical biopsy in the same quadrant as the target lesion, have intact nipples, have an ECOG score of 0-1 3. Able to give consent
Key exclusion criteria	Subjects may not participate in the clinical trial if they meet ANY of the following criteria: 1. Currently pregnant within the past 6 months 2. Currently lactating or lactated within the past 6 months 3. Have received chemotherapy within the past 6 months 4. Have an active infection in the breast 5. Have silicone injections or breast implants (pre-pectoral) that disrupt the ductal architecture of the breast 6. Have prior breast surgery that may cause the ductal system not to communicate with the nipple, as determined by the clinician 7. Be unwilling or unable to provide written informed consent.
Date of first enrolment	09/02/2006
Date of final enrolment	31/08/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Breast Diagnostic Unit

London
SW3 6JJ
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

The Royal Marsden NHS Foundation Trust (UK), NHS R&D Support Funding

No information available

Breakthrough Breast Cancer
Private sector organisation / Other non-profit organizations

Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

No publications found in PubMed, verifying study status with principal investigator.