Breast CancerNCT00041353
Comparison of Biomarkers Based on Fine-Needle Aspiration in Women at Increased or Normal Risk of Breast Cancer
A study testing cytology specimen collection procedure, comparison of screening methods and study of high risk factors in people with Breast Cancer, run by Fox Chase Cancer Center.
Trial summary
RATIONALE: Examining biomarkers in fine-needle aspiration specimens from women at risk for breast cancer may improve the ability to detect breast cancer cells early and plan effective treatment. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- cytology specimen collection procedure, comparison of screening methods and study of high risk factors
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Sep 2002
- Phase
- Interventional
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Increased risk of breast cancer as determined by 1 or more first-degree relatives (mother, sister, or daughter) with a history of breast cancer OR a personal history of atypical hyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ of the breast OR
- No increased risk of breast cancer as determined by a lack of the above conditions
- Scheduled to undergo elective breast surgery for removal of a mammographic lesion or palpable breast lump
- No prior bilateral mastectomy or bilateral breast irradiation
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 30 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No active invasive malignancy in any site except basal cell or squamous cell skin cancer
- No significant medical or psychiatric problems that would preclude study
- No evidence of excessive use of narcotics or drug dependency
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
About this study
Official title: Breast Cancer Biomarkers Based on Fine Needle Aspirates
RATIONALE: Examining biomarkers in fine-needle aspiration specimens from women at risk for breast cancer may improve the ability to detect breast cancer cells early and plan effective treatment.
PURPOSE: Screening trial to compare specific biomarkers based on fine-needle aspiration specimens from women at increased or normal risk of breast cancer.
Read the detailed description
OBJECTIVES:
- Compare specific biomarkers, including cellular morphology (cytology), proliferation index (Ki-67), p53 expression, and LOH in chromosome 9p at locus DS9157, in fine needle aspirate specimens from women at increased vs normal risk of breast cancer.
- Determine whether these specimens are adequate to perform the biomarker assays and whether this technique could be used in the general outpatient setting.
- Determine whether biomarker levels in these patients are concordant or discordant with individual clinical risk of breast cancer.
- Determine whether 1 or more biomarkers can distinguish high-risk from control patients.
- Correlate specific biomarkers and changes in biomarker levels with pathologic diagnosis from the breast biopsy.
OUTLINE: Patients undergo fine needle aspiration of normal appearing breast tissue prior to the beginning of elective surgery. Specimens are analyzed for the presence of specific biomarkers.
PROJECTED ACCRUAL: Approximately 156 patients will be accrued for this study within 3 years.
- Conditions
- Breast Cancer
- Being tested
- cytology specimen collection procedure, comparison of screening methods, study of high risk factors
- Keywords
- ductal breast carcinoma in situ, lobular breast carcinoma in situ
- 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.
cytology specimen collection procedureOther
comparison of screening methodsProcedure or surgery
study of high risk factorsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2003 (estimated)
- Primary completionSep 2002
- Study completionSep 2002
Why it stopped: Study was not activated at Fox Chase Cancer Center
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 Fox Chase Cancer CenterThe 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 N/A
- Primary purpose
- Screening
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael H. Torosian, MD, Study chair, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041353
- Sponsor's protocol ID
- FCCC-02010
- Other IDs
- CDR0000069491, NCI-G02-2095
- Status last verified
- Jul 2013
- First submitted
- 8 Jul 2002
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Biomarkers Based on Fine Needle Aspirates
- ClinicalTrials.gov ID
- NCT00041353
- Acronym / sponsor ID
- FCCC-02010
- Conditions
- Breast Cancer
- Keywords
- ductal breast carcinoma in situ, lobular breast carcinoma in situ
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not activated at Fox Chase Cancer Center
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Primary completion
- Sep 2002 (actual)
- Study completion
- Sep 2002 (actual)
- First posted
- 26 May 2003 (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: Examining biomarkers in fine-needle aspiration specimens from women at risk for breast cancer may improve the ability to detect breast cancer cells early and plan effective treatment.
PURPOSE: Screening trial to compare specific biomarkers based on fine-needle aspiration specimens from women at increased or normal risk of breast cancer.
Detailed description
OBJECTIVES:
- Compare specific biomarkers, including cellular morphology (cytology), proliferation index (Ki-67), p53 expression, and LOH in chromosome 9p at locus DS9157, in fine needle aspirate specimens from women at increased vs normal risk of breast cancer.
- Determine whether these specimens are adequate to perform the biomarker assays and whether this technique could be used in the general outpatient setting.
- Determine whether biomarker levels in these patients are concordant or discordant with individual clinical risk of breast cancer.
- Determine whether 1 or more biomarkers can distinguish high-risk from control patients.
- Correlate specific biomarkers and changes in biomarker levels with pathologic diagnosis from the breast biopsy.
OUTLINE: Patients undergo fine needle aspiration of normal appearing breast tissue prior to the beginning of elective surgery. Specimens are analyzed for the presence of specific biomarkers.
PROJECTED ACCRUAL: Approximately 156 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Screening
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 |
|---|---|---|
| cytology specimen collection procedure | Other | – |
| comparison of screening methods | Procedure or surgery | – |
| study of high risk factors | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 11 Jul 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.
Michael H. Torosian, MD study chair
Fox Chase Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing cytology specimen collection procedure, comparison of screening methods and study of high risk factors in people with Breast Cancer, run by Fox Chase Cancer Center.
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: withdrawn, as of the sponsor's last update on 11 Jul 2013. 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 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.
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 11 Jul 2013.