Breast CancerNCT00081003
Nipple Aspiration, Ductal Lavage, and Duct Endoscopy in Screening Women at Moderate-to-High Risk of Developing Breast Cancer
A study testing gene expression analysis, protein expression analysis and cytology specimen collection procedure in people with Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
RATIONALE: Screening tests, such as nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect cancer cells early and plan more effective treatment for breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- gene expression analysis, protein expression analysis and cytology specimen collection procedure
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2003to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
DISEASE CHARACTERISTICS:
- Significant family history or prior atypical biopsy indicative of a moderate or high risk of developing breast cancer
- No concurrent inflammatory breast cancer
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 to 64
Sex
- Female
Menopausal Status
- Premenopausal or postmenopausal
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No prior allergy to EMLA cream or lidocaine
- No severe illness that would preclude study participation
- No mental illness or handicap that would preclude study compliance
- No concurrent active infection or inflammation in the breast being studied
- Not unconscious
- Not pregnant
- No nursing within the past 12 months
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- No prior subareolar surgery (e.g., microdochectomy or major duct excision) that may disrupt the ductal systems within 2 cm of the nipple
- No prior breast implantation on proposed lavage side
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Intraduct Environment: A Novel Approach to Risk Assessment of Women With a Family History of Breast Cancer
RATIONALE: Screening tests, such as nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect cancer cells early and plan more effective treatment for breast cancer.
PURPOSE: This clinical trial is studying how well nipple aspiration, ductal lavage, and breast duct endoscopy work in detecting cancer cells in healthy women who are at moderate-to-high risk of developing breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the incidence of mild or severe cellular atypia in nipple aspirate fluid of healthy women at moderate to high risk of developing breast cancer, defined by family history or prior atypical biopsy.
Secondary
- Correlate cellular atypia with breast cancer, biochemical tumor markers, growth factors, and genetic and protein markers in these participants.
- Determine cancer risk and incidence utilizing these methods of screening in these participants.
- Observe the natural history of atypia in these participants over a total of 10 years.
- Determine whether these techniques may serve as supplementary tools in future screening of these participants.
OUTLINE: Participants under 50 years of age undergo nipple aspiration every twelve months for 3 years. Participants over 50 years of age undergo nipple aspiration every 18 months for 4.5 years.
Participants with significant cellular atypia in nipple aspirate fluid undergo ductal lavage and endoscopy.
Participants are followed annually for a total of 10 years.
PROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study within approximately 4 years.
- Conditions
- Breast Cancer
- Being tested
- gene expression analysis, protein expression analysis, cytology specimen collection procedure, laboratory biomarker analysis, physiologic testing
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
protein expression analysisGenetic
cytology specimen collection procedureOther
laboratory biomarker analysisOther
physiologic testingOther
breast duct lavageProcedure or surgery
endoscopic biopsyProcedure or surgery
study of high risk factorsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2004 (estimated)
- Study startNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng), Study chair, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081003
- Sponsor's protocol ID
- CDR0000358797
- Other IDs
- RMNHS-2278, EU-20352
- Status last verified
- Dec 2005
- First submitted
- 7 Apr 2004
- Last updated
- 23 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intraduct Environment: A Novel Approach to Risk Assessment of Women With a Family History of Breast Cancer
- ClinicalTrials.gov ID
- NCT00081003
- Acronym / sponsor ID
- CDR0000358797
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2003
- First posted
- 8 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Screening tests, such as nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect cancer cells early and plan more effective treatment for breast cancer.
PURPOSE: This clinical trial is studying how well nipple aspiration, ductal lavage, and breast duct endoscopy work in detecting cancer cells in healthy women who are at moderate-to-high risk of developing breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the incidence of mild or severe cellular atypia in nipple aspirate fluid of healthy women at moderate to high risk of developing breast cancer, defined by family history or prior atypical biopsy.
Secondary
- Correlate cellular atypia with breast cancer, biochemical tumor markers, growth factors, and genetic and protein markers in these participants.
- Determine cancer risk and incidence utilizing these methods of screening in these participants.
- Observe the natural history of atypia in these participants over a total of 10 years.
- Determine whether these techniques may serve as supplementary tools in future screening of these participants.
OUTLINE: Participants under 50 years of age undergo nipple aspiration every twelve months for 3 years. Participants over 50 years of age undergo nipple aspiration every 18 months for 4.5 years.
Participants with significant cellular atypia in nipple aspirate fluid undergo ductal lavage and endoscopy.
Participants are followed annually for a total of 10 years.
PROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study within approximately 4 years.
Study design
- Primary purpose
- Screening
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene expression analysis | Genetic | – |
| protein expression analysis | Genetic | – |
| cytology specimen collection procedure | Other | – |
| laboratory biomarker analysis | Other | – |
| physiologic testing | Other | – |
| breast duct lavage | Procedure or surgery | – |
| endoscopic biopsy | Procedure or surgery | – |
| study of high risk factors | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng) study chair
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gene expression analysis, protein expression analysis and cytology specimen collection procedure in people with Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2014.