Condition category
Cancer
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
27/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Gerald Gui

ORCID ID

Contact details

Breast Diagnostic Unit
Royal Marsden NHS Trust
Fulham Road
London
SW3 6JJ
United Kingdom
+44 (0)20 7487 5558
gerald.gui@rmh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0258175369

Study information

Scientific title

Acronym

INTEND I (intraoperative endoscopic evaluation of duct epithelium)

Study hypothesis

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

Royal Marsden REC at South London REC Office, St George's University of London, 20/03/2006, ref: 06/Q0801/17

Study design

Randomised non-blinded phase III trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Cancer: Breast

Intervention

Test intervention vs standardized intervention

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

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 trial start date

09/02/2006

Overall trial end date

31/08/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

176

Participant 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.

Recruitment start date

09/02/2006

Recruitment end date

31/08/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Breast Diagnostic Unit
London
SW3 6JJ
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Breakthrough Breast Cancer

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes