Breast CancerNCT00897208
Studying Biomarkers in Nipple Fluid, Urine, and Blood Samples From Women With Newly Diagnosed Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer and in Women at Risk of Developing Breast Cancer
An observational study of Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
RATIONALE: Studying samples of nipple fluid, urine, and blood in the laboratory from patients with cancer and from patients at risk of developing cancer may help doctors identify and learn more about biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages 19 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- high performance liquid chromatography, laboratory biomarker analysis and mass spectrometry
- Type of treatment
- Surgery or procedure
- How many people
- 316 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2005to 30 Jun 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 19 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target population is adult women, ages 19 to 80 years of age. In 2003, there were approximately 2000 new and 3000 established patient visits in the Breast Diagnostic Clinic (BDC) and Breast Cancer Clinic (BCC) Our new patients include those seen in the BDC with new breast concerns and those at seeking counseling regarding a family history or at high risk for developing breast cancer, as well as those women seen in the BCC with a new diagnosis of invasive or non-invasive breast cancer.
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Newly diagnosed (within 30 calendar days of diagnosis) stage I or II breast cancer
- Node-negative or node-positive disease
- Newly diagnosed ductal carcinoma in situ (stage 0) of the breast
- At high risk of developing breast cancer, as indicated by at least 1 of the following criteria:
- Gail model 5-year risk score ≥ 1.66%
- Gail model lifetime-risk estimate ≥ 20%
- Known deleterious BRCA 1 or 2 gene mutation carrier
- History of lobular carcinoma in situ or atypical ductal or lobular hyperplasia
- At low or average risk of developing breast cancer (control group)
- Gail model 5-year risk score < 1.66% or lifetime risk < 20%
- No advanced breast cancer
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Pre- or post-menopausal
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for breast cancer or any other cancer
- More than 3 months since prior and no concurrent estrogen or other hormones
- More than 3 months since prior oral contraceptives
- No concurrent selective estrogen receptor modulators (tamoxifen citrate or raloxifene)
- No concurrent aromatase inhibitors
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
About this study
Official title: Estrogen-DNA Adducts in Breast, Urine and Serum as Biomarkers of Breast Cancer Risk
RATIONALE: Studying samples of nipple fluid, urine, and blood in the laboratory from patients with cancer and from patients at risk of developing cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors learn more about breast cancer and identify patients at risk of developing breast cancer.
PURPOSE: This laboratory study is looking at biomarkers in nipple fluid, urine, and blood samples from women with newly diagnosed ductal carcinoma in situ or stage I or stage II breast cancer and in women at risk of developing breast cancer.
Read the detailed description
OBJECTIVES:
- To determine the levels of catechol estrogens (CE), CE metabolites, CE-DNA adducts, and CE conjugates in nipple aspirate fluid samples obtained from women with newly diagnosed ductal carcinoma in situ or stage I or II breast cancer and from women at high risk of developing breast cancer.
OUTLINE: Patients with newly diagnosed breast cancer or at high risk of developing breast cancer undergo nipple aspiration. The nipple aspirate fluid is obtained from the unaffected breast and is analyzed for 31 estrogen metabolites, conjugates, and depurinating DNA adducts by high-performance liquid chromatography (LC) with electrochemical and mass spectrometric detectors. All patients undergo urine and serum sample collection. The urine samples are analyzed by ultraperformance LC monitored by tandem mass spectrometry for estrogen metabolites, conjugates, and depurinating DNA adducts.
Patients' charts are reviewed to obtain information about age, race, general health, any endocrine disorders, history of cancer, estrogen and progesterone receptor status, and HER2/neu status (for patients with newly diagnosed breast cancer), menopausal status, reproductive history, history of breast disease, medication use, smoking history, and history of alcohol consumption.
- Conditions
- Breast Cancer
- Being tested
- high performance liquid chromatography, laboratory biomarker analysis, mass spectrometry, medical chart review, evaluation of cancer risk factors
- Keywords
- breast cancer, ductal breast carcinoma in situ, breast cancer in situ, stage IA breast cancer, stage IB breast cancer, stage II breast cancer
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high performance liquid chromatographyOther
laboratory biomarker analysisOther
mass spectrometryOther
medical chart reviewOther
evaluation of cancer risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the levels of estrogens, catechol estrogen (CE) metabolites, CE-glutathione conjugates, and CE-DNA adducts (N3Ade and N7Gua) among healthy women, high-risk women, and women with breast cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start20 May 2005
- Primary completion17 Jun 2010
- Study completion30 Jun 2015
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 Mayo ClinicThe 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
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandhya Pruthi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897208
- Sponsor's protocol ID
- 19-2005
- Other IDs
- 19-2005, 06-008665
- Status last verified
- Oct 2018
- First submitted
- 9 May 2009
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estrogen-DNA Adducts in Breast, Urine and Serum as Biomarkers of Breast Cancer Risk
- ClinicalTrials.gov ID
- NCT00897208
- Acronym / sponsor ID
- 19-2005
- Conditions
- Breast Cancer
- Keywords
- breast cancer, ductal breast carcinoma in situ, breast cancer in situ, stage IA breast cancer, stage IB breast cancer, stage II breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 May 2005 (actual)
- Primary completion
- 17 Jun 2010 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 12 May 2009 (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: Studying samples of nipple fluid, urine, and blood in the laboratory from patients with cancer and from patients at risk of developing cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors learn more about breast cancer and identify patients at risk of developing breast cancer.
PURPOSE: This laboratory study is looking at biomarkers in nipple fluid, urine, and blood samples from women with newly diagnosed ductal carcinoma in situ or stage I or stage II breast cancer and in women at risk of developing breast cancer.
Detailed description
OBJECTIVES:
- To determine the levels of catechol estrogens (CE), CE metabolites, CE-DNA adducts, and CE conjugates in nipple aspirate fluid samples obtained from women with newly diagnosed ductal carcinoma in situ or stage I or II breast cancer and from women at high risk of developing breast cancer.
OUTLINE: Patients with newly diagnosed breast cancer or at high risk of developing breast cancer undergo nipple aspiration. The nipple aspirate fluid is obtained from the unaffected breast and is analyzed for 31 estrogen metabolites, conjugates, and depurinating DNA adducts by high-performance liquid chromatography (LC) with electrochemical and mass spectrometric detectors. All patients undergo urine and serum sample collection. The urine samples are analyzed by ultraperformance LC monitored by tandem mass spectrometry for estrogen metabolites, conjugates, and depurinating DNA adducts.
Patients' charts are reviewed to obtain information about age, race, general health, any endocrine disorders, history of cancer, estrogen and progesterone receptor status, and HER2/neu status (for patients with newly diagnosed breast cancer), menopausal status, reproductive history, history of breast disease, medication use, smoking history, and history of alcohol consumption.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population is adult women, ages 19 to 80 years of age. In 2003, there were approximately 2000 new and 3000 established patient visits in the Breast Diagnostic Clinic (BDC) and Breast Cancer Clinic (BCC) Our new patients include those seen in the BDC with new breast concerns and those at seeking counseling regarding a family history or at high risk for developing breast cancer, as well as those women seen in the BCC with a new diagnosis of invasive or non-invasive 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 |
|---|---|---|
| high performance liquid chromatography | Other | – |
| laboratory biomarker analysis | Other | – |
| mass spectrometry | Other | – |
| medical chart review | Other | – |
| evaluation of cancer risk factors | Procedure or surgery | – |
Primary outcome
Comparison of the levels of estrogens, catechol estrogen (CE) metabolites, CE-glutathione conjugates, and CE-DNA adducts (N3Ade and N7Gua) among healthy women, high-risk women, and women with breast cancer
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 5 Oct 2018.
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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.
Sandhya Pruthi, MD principal investigator
Mayo Clinic
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 Mayo Clinic 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 5 Oct 2018. 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?
Comparison of the levels of estrogens, catechol estrogen (CE) metabolites, CE-glutathione conjugates, and CE-DNA adducts (N3Ade and N7Gua) among healthy women, high-risk women, and women with breast cancer. 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 5 Oct 2018.