Breast CancerPhase 2NCT00082979
Duct Endoscopy in Assessing Cellular Atypia in the Breast Duct Fluid of Women With a Genetic Risk for Breast Cancer
A Phase 2 study testing cytogenetic analysis, proteomic profiling 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: Diagnostic procedures, such as breast duct endoscopy, may improve the ability to detect breast cancer earlier and plan more effective treatment. PURPOSE: This phase II trial is studying how well breast duct endoscopy works in assessing cellular atypia (abnormal cells) in the breast ducts of women with a… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- cytogenetic analysis, proteomic profiling and cytology specimen collection procedure
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2003to not given
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS:
- Diagnosis of cellular atypia in nipple aspirate or ductal lavage fluid
- Enrollment on RMNHS-2242 or RMNHS-2269 required
- No inflammatory breast cancer
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 to 64
Sex
- Female
Menopausal Status
- Any status
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No prior allergy to eutectic mixture of local anesthetics (EMLA®) cream or lidocaine
- No severe illness that would preclude study participation
- No mental illness or handicap that would preclude study compliance
- No active infection or inflammation in the breast being studied
- No nursing within the past 12 months
- Not pregnant
- Not unconscious
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- No prior tamoxifen
Radiotherapy
- Not specified
Surgery
- No prior subareolar surgery (e.g., papilloma resections, biopsies, or fine needle aspirations) or any other surgery that may disrupt the ductal systems within 2 cm of the nipple
- Biopsies and fine needle aspirations > 2 cm from the nipple are allowed
- No prior breast implantation on proposed lavage side
Other
- No prior chemopreventative agents
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden - London
London, England, SW3 6JJ
Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng), 44-20-7808-2783, gerald.gui@rmh.nhs.uk
About this study
Official title: Evaluation of the Role of Duct Endoscopy in the Assessment of Cellular Atypia Within Breast Duct Fluid in High-Risk Women Carrying BRCA1/2 or p53 Gene Mutations
RATIONALE: Diagnostic procedures, such as breast duct endoscopy, may improve the ability to detect breast cancer earlier and plan more effective treatment.
PURPOSE: This phase II trial is studying how well breast duct endoscopy works in assessing cellular atypia (abnormal cells) in the breast ducts of women with a genetic risk for breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Correlate cell yield and morphology findings from ductal lavage with duct endoscopy findings and any subsequent surgical pathology findings in high-risk women with BRCA1, BRCA2, or p53 gene mutations who have cellular atypia.
- Determine the prevalence of occult breast cancer in patients with cellular atypia undergoing duct endoscopy.
Secondary
- Determine patient acceptance of duct endoscopy.
- Perform immunohistochemical analysis (including estrogen receptor, progesterone receptor, HER2-neu receptor, epidermal growth factor receptor, p53, and proliferation marker expression) for markers potentially associated with breast cancer in these patients.
- Determine potential molecular markers of malignancy by gene methylation, gene expression, and proteomics in these patients.
OUTLINE: Patients undergo nipple aspiration to identify productive ducts and collect fluid for tumor marker assessment followed by ductal lavage over 15 minutes. Patients undergo duct endoscopy over approximately 30 minutes under local anesthesia. If no abnormality is found, duct endoscopy is repeated in 6 months. If the repeat duct endoscopy is normal, patients continue to undergo nipple aspiration or ductal lavage as specified in protocols RMNHS-2242 and RMNHS-2269. If an abnormality is found during either the initial or repeat duct endoscopy, patients may undergo further assessment comprising imaging or biopsy and/or appropriate surgical intervention.
Fluid is analyzed for tumor markers by immunohistochemistry. Candidate genes are analyzed by gene methylation studies, gene expression arrays, and proteomic analysis.
Patients are followed for at least 5 years.
PROJECTED ACCRUAL: A total of 45-60 patients will be accrued for this study within 2 years.
- Conditions
- Breast Cancer
- Being tested
- cytogenetic analysis, proteomic profiling, cytology specimen collection procedure, immunohistochemistry staining method, laboratory biomarker analysis
- 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.
cytogenetic analysisGenetic
proteomic profilingGenetic
cytology specimen collection procedureOther
laboratory biomarker analysisOther
breast duct lavageProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of cell yields and morphology from ductal lavage vs the ductal anatomy visualized at duct endoscopy
Prevalence of occult pathology (malignant and benign) as assessed by duct endoscopy on intraduct sampling
Sensitivity and specificity of ductal lavage to duct endoscopy in detecting atypia or malignancy
Comparison of cell yields vs final surgical pathology
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2004 (estimated)
- Study startOct 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 2
- Primary purpose
- Diagnosis
- Enrolment
- 60 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), Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082979
- Sponsor's protocol ID
- CDR0000361751
- Other IDs
- RMNHS-2282, EU-20351
- Status last verified
- Dec 2005
- First submitted
- 14 May 2004
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Duct Endoscopy in the Assessment of Cellular Atypia Within Breast Duct Fluid in High-Risk Women Carrying BRCA1/2 or p53 Gene Mutations
- ClinicalTrials.gov ID
- NCT00082979
- Acronym / sponsor ID
- CDR0000361751
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2003
- First posted
- 17 May 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: Diagnostic procedures, such as breast duct endoscopy, may improve the ability to detect breast cancer earlier and plan more effective treatment.
PURPOSE: This phase II trial is studying how well breast duct endoscopy works in assessing cellular atypia (abnormal cells) in the breast ducts of women with a genetic risk for breast cancer.
Detailed description
OBJECTIVES:
Primary
- Correlate cell yield and morphology findings from ductal lavage with duct endoscopy findings and any subsequent surgical pathology findings in high-risk women with BRCA1, BRCA2, or p53 gene mutations who have cellular atypia.
- Determine the prevalence of occult breast cancer in patients with cellular atypia undergoing duct endoscopy.
Secondary
- Determine patient acceptance of duct endoscopy.
- Perform immunohistochemical analysis (including estrogen receptor, progesterone receptor, HER2-neu receptor, epidermal growth factor receptor, p53, and proliferation marker expression) for markers potentially associated with breast cancer in these patients.
- Determine potential molecular markers of malignancy by gene methylation, gene expression, and proteomics in these patients.
OUTLINE: Patients undergo nipple aspiration to identify productive ducts and collect fluid for tumor marker assessment followed by ductal lavage over 15 minutes. Patients undergo duct endoscopy over approximately 30 minutes under local anesthesia. If no abnormality is found, duct endoscopy is repeated in 6 months. If the repeat duct endoscopy is normal, patients continue to undergo nipple aspiration or ductal lavage as specified in protocols RMNHS-2242 and RMNHS-2269. If an abnormality is found during either the initial or repeat duct endoscopy, patients may undergo further assessment comprising imaging or biopsy and/or appropriate surgical intervention.
Fluid is analyzed for tumor markers by immunohistochemistry. Candidate genes are analyzed by gene methylation studies, gene expression arrays, and proteomic analysis.
Patients are followed for at least 5 years.
PROJECTED ACCRUAL: A total of 45-60 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not 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 |
|---|---|---|
| cytogenetic analysis | Genetic | – |
| proteomic profiling | Genetic | – |
| cytology specimen collection procedure | Other | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
| breast duct lavage | Procedure or surgery | – |
Primary outcome
Comparison of cell yields and morphology from ductal lavage vs the ductal anatomy visualized at duct endoscopy
Prevalence of occult pathology (malignant and benign) as assessed by duct endoscopy on intraduct sampling
Sensitivity and specificity of ductal lavage to duct endoscopy in detecting atypia or malignancy
Comparison of cell yields vs final surgical pathology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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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)
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 Phase 2 study testing cytogenetic analysis, proteomic profiling 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: status not confirmed, as of the sponsor's last update on 26 Aug 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of cell yields and morphology from ductal lavage vs the ductal anatomy visualized at duct endoscopy. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 26 Aug 2013.