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

N0258175375

Study information

Scientific title

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, Paget’s 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

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

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