Breast CancerNCT00429988
Study of Ductal Lavage in Women at High Risk for Breast Cancer
An observational study of Breast Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
RATIONALE: Collecting samples of fluid using ductal lavage and nipple aspiration from participants at high risk for breast cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- fluorescence in situ hybridization, polymerase chain reaction and proteomic profiling
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Jun 2004
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women at increased risk for breast cancer
DISEASE CHARACTERISTICS:
- High risk for breast cancer defined as 1 of the following:
- History of atypical hyperplasia or atypia found on biopsy, fine-needle aspiration, or ductal lavage
- Family history of cancer meeting at least 1 of the following criteria:
- Single relative with multiple primary cancers
- One or more relative under 40 years of age with breast cancer OR bilateral breast cancer
- Two or more relatives with ovarian cancer
- Two or more relatives with breast cancer and 1 is under 50 years of age
- One or more relative with breast cancer plus ≥ 1 relative with ovarian cancer
- Ashkenazi Jewish descent AND relative with breast cancer under 50 years of age OR ovarian cancer at any age
- BRCA1 and/or BRCA2 mutation
- Prior breast cancer in contralateral breast
- Gail risk > 1.7%
- Spontaneous nipple discharge
- Serum estradiol > 10 pmol/L
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- Over 18
Sex
- Female
Menopausal status
- Not specified
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Able to obtain breast duct fluids
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- More than 4 months since prior tamoxifen or raloxifene
Radiotherapy
- No prior radiotherapy to the breast
Surgery
- No prior incisional or excisional biopsy within 1.5 cm of nipple
Other
- No prior neoadjuvant therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: Ductal Lavage to Monitor and Treat High Risk Women
RATIONALE: Collecting samples of fluid using ductal lavage and nipple aspiration from participants at high risk for breast cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This clinical trial is using ductal lavage to collect fluid from women at high risk for breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the volume of atypical cells collected from ductal lavage in women at increased risk for breast cancer.
Secondary
- Determine assay techniques to analyze nipple aspirate fluid and ductal lavage fluid samples from these participants.
- Analyze the nipple aspirate fluid from these participants for specific and global protein signatures.
- Determine the replicability of markers in serial assays of these participants.
- Determine the percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy.
OUTLINE: This is a multicenter study.
Participants undergo nipple aspirate fluid and ductal lavage fluid collection. Fluid samples are analyzed using cytological analysis, immunohistochemistry, fluorescent in situ hybridization, or in situ polymerase chain reaction. Protein patterns are identified using mass spectrometry.
Participants found to have atypia undergo repeat lavage at 3-6 months and 1 year. Participants with normal fluid samples undergo repeat lavage at 1 year.
PROJECTED ACCRUAL: A total of 30 participants will accrued for this study within 2-3 months.
- Conditions
- Breast Cancer
- Being tested
- fluorescence in situ hybridization, polymerase chain reaction, proteomic profiling, cytology specimen collection procedure, immunohistochemistry staining method
- 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.
fluorescence in situ hybridizationGenetic
polymerase chain reactionGenetic
proteomic profilingGenetic
cytology specimen collection procedureOther
breast duct lavageProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of atypical cells per ductal lavage sample
Secondary outcomes (4)
Assay techniques development for nipple aspirate fluid and ductal lavage fluid analysis
Specific and global protein signature analysis of nipple aspirate
Replicability of markers in serial assays
Percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startAug 2002
- Primary completionJun 2004
- Study completionJun 2004
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 University of California, San FranciscoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Laura J. Esserman, MD, MBA, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429988
- Sponsor's protocol ID
- CDR0000378088
- Other IDs
- UCSF-TEMP01
- Status last verified
- Sep 2012
- First submitted
- 30 Jan 2007
- Last updated
- 26 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ductal Lavage to Monitor and Treat High Risk Women
- ClinicalTrials.gov ID
- NCT00429988
- Acronym / sponsor ID
- CDR0000378088
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2002
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 1 Feb 2007 (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: Collecting samples of fluid using ductal lavage and nipple aspiration from participants at high risk for breast cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This clinical trial is using ductal lavage to collect fluid from women at high risk for breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the volume of atypical cells collected from ductal lavage in women at increased risk for breast cancer.
Secondary
- Determine assay techniques to analyze nipple aspirate fluid and ductal lavage fluid samples from these participants.
- Analyze the nipple aspirate fluid from these participants for specific and global protein signatures.
- Determine the replicability of markers in serial assays of these participants.
- Determine the percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy.
OUTLINE: This is a multicenter study.
Participants undergo nipple aspirate fluid and ductal lavage fluid collection. Fluid samples are analyzed using cytological analysis, immunohistochemistry, fluorescent in situ hybridization, or in situ polymerase chain reaction. Protein patterns are identified using mass spectrometry.
Participants found to have atypia undergo repeat lavage at 3-6 months and 1 year. Participants with normal fluid samples undergo repeat lavage at 1 year.
PROJECTED ACCRUAL: A total of 30 participants will accrued for this study within 2-3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women at increased risk for breast cancer
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 |
|---|---|---|
| fluorescence in situ hybridization | Genetic | – |
| polymerase chain reaction | Genetic | – |
| proteomic profiling | Genetic | – |
| cytology specimen collection procedure | Other | – |
| immunohistochemistry staining method | Other | – |
| breast duct lavage | Procedure or surgery | – |
Primary outcome
Average number of atypical cells per ductal lavage sample
4 secondary outcomes
Assay techniques development for nipple aspirate fluid and ductal lavage fluid analysis
Specific and global protein signature analysis of nipple aspirate
Replicability of markers in serial assays
Percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy
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 26 Sep 2012.
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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.
Laura J. Esserman, MD, MBA principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of California, San Francisco at 1 site in United States.
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 26 Sep 2012. 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 States. 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.
What does the primary outcome measure?
Average number of atypical cells per ductal lavage sample. 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 Sep 2012.