Breast CancerNCT00898976
Biomarkers in Native American Women With Breast Cancer
An observational study of Breast Cancer, run by Alliance for Clinical Trials in Oncology.
Trial summary
RATIONALE: Studying samples of tumor tissue in the laboratory from Native American women with breast cancer may help doctors identify and learn more about biomarkers related to breast cancer in these patients. It may also help doctors learn more about the prognosis of these patients. 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?
- immunohistochemistry staining method and laboratory biomarker analysis
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Aug 1998to May 2007
- 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: Native American women with primary adenocarcinoma of the breast with prior surgical treatment for breast cancer within the Aberdeen or Phoenix areas of the Indian Health Service or the Alaska area of the Native Health Service between 1990-2000.
DISEASE CHARACTERISTICS:
- Diagnosis of primary adenocarcinoma of the breast in Native American women
- Prior surgical treatment for breast cancer within the Aberdeen or Phoenix areas of the Indian Health Service or the Alaska area of the Native Health Service between 1990-2000
- Paraffin-embedded tissue available
- Paraffin-embedded tissue available from Caucasian women with breast cancer enrolled on NCCTG-77-30-51 or the Mayo Breast Cancer Registry
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
About this study
Official title: Molecular Markers in Native American Women With Breast Cancer
RATIONALE: Studying samples of tumor tissue in the laboratory from Native American women with breast cancer may help doctors identify and learn more about biomarkers related to breast cancer in these patients. It may also help doctors learn more about the prognosis of these patients.
PURPOSE: This laboratory study is looking at biomarkers in Native American women with breast cancer.
Read the detailed description
OBJECTIVES:
- Evaluate a selected panel of molecular markers in tissue specimens from Native American women with breast cancer.
- Determine which molecular markers provide independent prognostic information with respect to traditional prognostic factors in these patients.
- Compare and contrast the prevalence of positivity in Native American women with breast cancer with an age- and stage-matched cohort of Caucasian women with breast cancer enrolled on clinical trial NCCTG-77-30-51 or the Mayo Breast Cancer Registry.
OUTLINE: Immunohistochemistry is performed on tumor samples to analyze the following molecular markers: estrogen receptor, progesterone receptor, c-erbB2, p53, Ki-67, Bcl-2, Bax, cyclin D-1, and insulin-like growth factor-1R.
- Conditions
- Breast Cancer
- Being tested
- immunohistochemistry staining method, laboratory biomarker analysis
- Keywords
- stage I breast cancer, stage II breast cancer, stage IV breast cancer, stage IIIA breast cancer, breast cancer in situ, recurrent breast cancer, stage IIIB breast cancer, inflammatory breast cancer, stage IIIC breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ, Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| Group I | Immunohistochemistry is performed on tumor samples to analyze the following molecular markers: estrogen receptor, progesterone receptor, c-erbB2, p53, Ki-67, Bcl-2, Bax, cyclin D-1, and insulin-like growth factor-1R. PROJECTED ACCRUAL: A total of 300 tissue samples (150 from Native American women and 150 from Caucasian women) will be accrued for this study. Receives: Other: immunohistochemistry staining method; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of a selected panel of molecular markers in tissue specimens from Native American women with breast cancer
Measured: Up to 5 years
Determination of which molecular markers provide independent prognostic information with respect to traditional prognostic factors
Measured: Up to 5 years
Comparison of the prevalence of positivity in Native American women with breast cancer with an age- and stage-matched cohort of Caucasian women with breast cancer enrolled on clinical trial NCCTG-77-30-51 or the Mayo Breast Cancer Registry
Measured: Up to 5 years
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 startAug 1998
- Primary completionMay 2007
- Study completionMay 2007
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 Alliance for Clinical Trials in OncologyThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Judith S. Kaur, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898976
- Sponsor's protocol ID
- NCCTG-97-95-51
- Other IDs
- NCCTG-979551, CDR0000078596, NCI-2013-00323
- Status last verified
- Jul 2016
- First submitted
- 9 May 2009
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Markers in Native American Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT00898976
- Acronym / sponsor ID
- NCCTG-97-95-51
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IV breast cancer, stage IIIA breast cancer, breast cancer in situ, recurrent breast cancer, stage IIIB breast cancer, inflammatory breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 1998
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (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 tumor tissue in the laboratory from Native American women with breast cancer may help doctors identify and learn more about biomarkers related to breast cancer in these patients. It may also help doctors learn more about the prognosis of these patients.
PURPOSE: This laboratory study is looking at biomarkers in Native American women with breast cancer.
Detailed description
OBJECTIVES:
- Evaluate a selected panel of molecular markers in tissue specimens from Native American women with breast cancer.
- Determine which molecular markers provide independent prognostic information with respect to traditional prognostic factors in these patients.
- Compare and contrast the prevalence of positivity in Native American women with breast cancer with an age- and stage-matched cohort of Caucasian women with breast cancer enrolled on clinical trial NCCTG-77-30-51 or the Mayo Breast Cancer Registry.
OUTLINE: Immunohistochemistry is performed on tumor samples to analyze the following molecular markers: estrogen receptor, progesterone receptor, c-erbB2, p53, Ki-67, Bcl-2, Bax, cyclin D-1, and insulin-like growth factor-1R.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Other: immunohistochemistry staining method, Other: laboratory biomarker analysisImmunohistochemistry is performed on tumor samples to analyze the following molecular markers: estrogen receptor, progesterone receptor, c-erbB2, p53, Ki-67, Bcl-2, Bax, cyclin D-1, and insulin-like growth factor-1R. PROJECTED ACCRUAL: A total of 300 tissue samples (150 from Native American women and 150 from Caucasian women) will be accrued for this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Native American women with primary adenocarcinoma of the breast with prior surgical treatment for breast cancer within the Aberdeen or Phoenix areas of the Indian Health Service or the Alaska area of the Native Health Service between 1990-2000.
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 |
|---|---|---|
| immunohistochemistry staining method | Other | Group I |
| laboratory biomarker analysis | Other | Group I |
Primary outcome
Evaluation of a selected panel of molecular markers in tissue specimens from Native American women with breast cancer
Time frame: Up to 5 years
Determination of which molecular markers provide independent prognostic information with respect to traditional prognostic factors
Time frame: Up to 5 years
Comparison of the prevalence of positivity in Native American women with breast cancer with an age- and stage-matched cohort of Caucasian women with breast cancer enrolled on clinical trial NCCTG-77-30-51 or the Mayo Breast Cancer Registry
Time frame: Up to 5 years
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 13 Jul 2016.
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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.
Judith S. Kaur, MD study chair
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Alliance for Clinical Trials in Oncology.
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 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluation of a selected panel of molecular markers in tissue specimens from Native American women with breast cancer (time frame: Up to 5 years). The study lists 3 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 13 Jul 2016.