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
N0258175375
Study information
Scientific title
A randomised controlled trial of duct endoscopy as an adjunct to standard surgery for pathological nipple discharge
Acronym
INTEND II
Study hypothesis
To clarify the future role of the intraduct approach in a systematic manner by a randomised controlled trial that would establish whether this approach should be encouraged or disparaged.
Ethics approval
The Royal Marsden Local Research Ethics Committee (LREC), 20/03/2006, ref: 06/Q0801/29
Study design
Randomised controlled 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
Randomised test intervention vs standardized intervention, non-blinded (Phase III)
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
1. Successful visualisation of lesions in the duct endoscopy group correlating to pathological findings
2. Size of the tissue resection in the DE versus no DE group
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2006
Overall trial end date
31/03/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. 100 RMH female patients undergoing duct excision biopsy for the routine management of PND with symptoms of either spontaneous symptomatic discharge from a single duct
2. Patients with bloodstained nipple discharge or abnormal cytology of the duct fluid
3. Routine preoperative screening: mammogram and ultrasound, where appropriate, in accordance with the breast unit protocol
4. Have not had previous periareolar incisions or surgical biopsy in the same quadrant as the target lesion
5. Have intact nipples
6. Have an ECOG score of 0-1
7. Able to give informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100
Participant exclusion criteria
1. Currently pregnant or 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 a previous history of breast cancer (including invasive carcinoma, Pagets disease and DCIS)
6. Have silicone injections or breast implants (pre-pectoral) that disrupt the ductal architecture of the breast
7. Have prior breast surgery that may cause the ductal system not to communicate with the nipple, as determined by the clinician
8. Be unwilling or unable to provide written informed consent
Recruitment start date
01/03/2006
Recruitment end date
31/03/2011
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
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