Breast CancerNCT00329017
Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer
An observational study of Breast Cancer, run by Carol Fabian, MD at 1 site in United States.
Trial summary
A study to examine the potential associations between common single nucleotide polymorphisms and pre-cancerous conditions in breast tissue specimens from postmenopausal women. 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?
- Fine needle aspiration
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to 12 Nov 2015
- 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: Post menopausal women, on or off hormone replacement therapy, at high risk of developing breast cancer
Who may be able to join
- postmenopausal women on or off hormone replacement therapy
- at high risk of developing breast cancer determined by family or personal history
- postmenopausal women not on hormone replacement therapy for at minimum six months prior to corresponding aspiration
- willing to participate in companion protocol (KUMC HSC#4601) for random periareolar fine needle aspiration (RPFNA) for correlational studies
Who cannot join
- women who have been on raloxifene, tamoxifen, letrozole, anastrozole or exemestane within the six months prior to RPFNA.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Correlation of SNP Patterns With Fine Needle Aspiration Cytomorphology in High Risk Postmenopausal Women
A study to examine the potential associations between common single nucleotide polymorphisms and pre-cancerous conditions in breast tissue specimens from postmenopausal women.
Read the detailed description
A study to examine the correlation between single nucleotide polymorphisms (SNPs) affecting steroid and carcinogen metabolism and benign breast tissue cytomorphology collected via random periareolar fine needle aspiration in postmenopausal women at increased risk for breast cancer and taking hormone replacement therapy.
- Conditions
- Breast Cancer
- Being tested
- Fine needle aspiration
- Keywords
- SNPs, single nucleotide polymorphism, breast atypia, breast epithelial hyperplasia, high risk for 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.
Fine needle aspirationProcedure or surgery
Fine needle aspiration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Post-menopausal women who are at increased risk for development of breast cancer on the basis of family or personal history. Receives: Procedure: Fine needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of SNP patterns with cytlomorphology of breast fine needle aspirates.
develoment of algorithm for prediction of risk of developing breast cancer.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startMay 2005
- Primary completion12 Nov 2015
- Study completion12 Nov 2015
Why it stopped: No patients enrolled
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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Fabian, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Intergenetics, Inc.
- Responsible party
- Sponsor-investigator, Carol Fabian, MD, University of Kansas Medical Center
- Investigators
- Carol J Fabian, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329017
- Sponsor's protocol ID
- 9814
- Status last verified
- Oct 2019
- First submitted
- 19 May 2006
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Global results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of SNP Patterns With Fine Needle Aspiration Cytomorphology in High Risk Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00329017
- Acronym / sponsor ID
- 9814
- Conditions
- Breast Cancer
- Keywords
- SNPs, single nucleotide polymorphism, breast atypia, breast epithelial hyperplasia, high risk for breast cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Carol Fabian, MDUniversity, hospital or other
- Collaborators
- Intergenetics, Inc.
- Study start
- May 2005
- Primary completion
- 12 Nov 2015 (actual)
- Study completion
- 12 Nov 2015 (actual)
- First posted
- 24 May 2006 (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.
A study to examine the potential associations between common single nucleotide polymorphisms and pre-cancerous conditions in breast tissue specimens from postmenopausal women.
Detailed description
A study to examine the correlation between single nucleotide polymorphisms (SNPs) affecting steroid and carcinogen metabolism and benign breast tissue cytomorphology collected via random periareolar fine needle aspiration in postmenopausal women at increased risk for breast cancer and taking hormone replacement therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Fine needle aspirationPost-menopausal women who are at increased risk for development of breast cancer on the basis of family or personal history. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post menopausal women, on or off hormone replacement therapy, at high risk of developing breast cancer
Key inclusion criteria (4 listed)
- postmenopausal women on or off hormone replacement therapy
- at high risk of developing breast cancer determined by family or personal history
- postmenopausal women not on hormone replacement therapy for at minimum six months prior to corresponding aspiration
- willing to participate in companion protocol (KUMC HSC#4601) for random periareolar fine needle aspiration (RPFNA) for correlational studies
Key exclusion criteria (1 listed)
- women who have been on raloxifene, tamoxifen, letrozole, anastrozole or exemestane within the six months prior to RPFNA.
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 |
|---|---|---|
| Fine needle aspirationFine needle aspiration | Procedure or surgery | 1 |
Primary outcome
Correlation of SNP patterns with cytlomorphology of breast fine needle aspirates.
Time frame: ongoing
develoment of algorithm for prediction of risk of developing breast cancer.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Individual participant dataSharing planned: No. Global results will be published.
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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.
Carol J Fabian, MD principal investigator
University of Kansas Medical Center
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 Carol Fabian, MD 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?
The sponsor lists 4 inclusion and 1 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 10 Oct 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Correlation of SNP patterns with cytlomorphology of breast fine needle aspirates. (time frame: ongoing). 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 10 Oct 2019.