Plain English Summary
Trial website
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
Duct endoscopy in the evaluation of breast cancer and surgical margins
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 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 trial start date
09/02/2006
Overall trial end date
31/08/2011
Reason abandoned (if study stopped)
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
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 organizations
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
Basic results (scientific)
Publication list