Breast CancerNCT00339248
Markers for Breast Cancer
An observational study of Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will analyze blood samples to identify substances that are associated with the development of breast cancer. It will determine if: Women who are diagnosed with a benign breast condition that is related to a considerably increased risk of breast cancer are more likely to have certain gene variants than women… Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 2,632 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to not given
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Potentially eligible premenopausal women include 2636 who did not have a previous or concurrent (within 60 days) diagnosis of breast cancer at the time of initial benign breast biopsy (study entry) and who have at least 4 mls of serum stored in the Frederick biorepository.
- Of those 2636, four women have a code indicating "refused study" in the "follow-up" variable, and despite evidence of their consent to the original study, will be omitted from all future use of study data or specimens.
- Participants also will be required to be Caucasian or African American (2599 or 98.6%), and to have a pathology report successfully retrieved from a participating hospital for review.
- All sample sizes subsequently cited in the text take these inclusion criteria into account, and those cited for objective 2 also incorporate adjustment for loss to follow-up.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
NCI Frederick Cancer Research Center
Frederick, Maryland, 21702-1201
About this study
Official title: Risk of Breast Cancer and Hyperplastic Conditions in the Breast Cancer Serum Bank in Relation to Inherited Genetic Variants
This study will analyze blood samples to identify substances that are associated with the development of breast cancer. It will determine if:
- Women who are diagnosed with a benign breast condition that is related to a considerably increased risk of breast cancer are more likely to have certain gene variants than women diagnosed with conditions related to very little increased breast cancer risk
- Women with benign breast conditions who subsequently develop breast cancer are more likely to have certain gene variants than women with similar benign conditions who do not develop breast cancer.
Read more
This study will examine blood samples from premenopausal women who underwent breast biopsy (removal of a small piece of breast tissue for microscopic examination) at four hospitals in Grand Rapids, MI, from 1977 to 1987 and were found to have benign breast disease. The women, who agreed to participate in a study of markers for breast cancer, also provided a blood sample and were interviewed for information on their breast cancer risk factors, family history of breast cancer, use of medications, and history of medical conditions.
This study will retrieve the biopsy reports for these women, determine which of them later developed breast cancer, and perform genotyping on their blood samples.
The information from this study may help in future diagnosis and treatment of breast cancer.
Read the detailed description
Prevention and treatment of intraepithelial neoplasia and benign pre-malignant conditions has become an important focus of the NCI's 2015 goal of eliminating suffering and death due to cancer, although very little is known about the factors that influence development of frank malignancy in those with high risk benign/precursor conditions. The Radiation Epidemiology and Biostatistics Branches of the NCI propose to evaluate the contribution of inherited genetic variation to benign pre-malignant breast conditions, and to subsequent breast cancer risk in women diagnosed with such conditions, in the Breast Cancer Serum Bank, a unique biospecimen resource housed at NCI since 1995. Premenopausal participants (N=2632) biopsied at an average age of 27 in 1977-1987, (many diagnosed with high risk benign breast conditions (moderate/florid breast hyperplasia and atypia)) were interviewed and provided a blood sample. Participant biopsy reports will be obtained for review and recoding, and participants will be traced for vital status and breast cancer development (expected n = 240 cases). Variants in genes related to hormone metabolism and cell signaling, processes implicated in the development of premalignant breast conditions, and in genes associated with cell cycle control and apoptosis, and thus possibly related to progression to breast cancer among women with premalignant breast conditions will be assessed at the NCI Central Genotyping Facility. We have a remarkable opportunity in this study to address scientific questions regarding breast carcinogenesis mechanisms at relatively little cost. Greater comprehension of the influence of inherited factors on distinct steps in the biological pathway, first from normal tissue to benign high risk breast tumors, and then hence the breast cancer, should contribute to our understanding of the molecular mechanisms that shape breast cancer development, and holds promise for the discovery and delivery of sound risk-adapted interventions for women with high risk premalignant conditions.
- Conditions
- Breast Cancer
- Keywords
- Hyperplasia, Atypia, Polymorphism, Progression, Epidemiology
- Medical subject headings
- Breast Neoplasms, Hyperplasia, Disease Progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study startDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Enrolment
- 2,632 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339248
- Sponsor's protocol ID
- 999905061
- Other IDs
- 05-C-N061
- Status last verified
- Oct 2007
- First submitted
- 19 Jun 2006
- Last updated
- 13 Mar 2009
- Results posted
- No
Publications
Alle KM, Henshall SM, Field AS, Sutherland RL. Cyclin D1 protein is overexpressed in hyperplasia and intraductal carcinoma of the breast. Clin Cancer Res. 1998 Apr;4(4):847-54.
PubMed 9563877Blomeke B, Bennett WP, Harris CC, Shields PG. Serum, plasma and paraffin-embedded tissues as sources of DNA for studying cancer susceptibility genes. Carcinogenesis. 1997 Jun;18(6):1271-5. doi: 10.1093/carcin/18.6.1271.
PubMed 9214613Boyd NF, Jensen HM, Cooke G, Han HL. Relationship between mammographic and histological risk factors for breast cancer. J Natl Cancer Inst. 1992 Aug 5;84(15):1170-9. doi: 10.1093/jnci/84.15.1170.
PubMed 1635085
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Breast Cancer and Hyperplastic Conditions in the Breast Cancer Serum Bank in Relation to Inherited Genetic Variants
- ClinicalTrials.gov ID
- NCT00339248
- Acronym / sponsor ID
- 999905061
- Conditions
- Breast Cancer
- Keywords
- Hyperplasia, Atypia, Polymorphism, Progression, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,632 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2004
- First posted
- 21 Jun 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.
This study will analyze blood samples to identify substances that are associated with the development of breast cancer. It will determine if:
- Women who are diagnosed with a benign breast condition that is related to a considerably increased risk of breast cancer are more likely to have certain gene variants than women diagnosed with conditions related to very little increased breast cancer risk
- Women with benign breast conditions who subsequently develop breast cancer are more likely to have certain gene variants than women with similar benign conditions who do not develop breast cancer.
This study will examine blood samples from premenopausal women who underwent breast biopsy (removal of a small piece of breast tissue for microscopic examination) at four hospitals in Grand Rapids, MI, from 1977 to 1987 and were found to have benign breast disease. The women, who agreed to participate in a study of markers for breast cancer, also provided a blood sample and were interviewed for information on their breast cancer risk factors, family history of breast cancer, use of medications, and history of medical conditions.
This study will retrieve the biopsy reports for these women, determine which of them later developed breast cancer, and perform genotyping on their blood samples.
The information from this study may help in future diagnosis and treatment of breast cancer.
Detailed description
Prevention and treatment of intraepithelial neoplasia and benign pre-malignant conditions has become an important focus of the NCI's 2015 goal of eliminating suffering and death due to cancer, although very little is known about the factors that influence development of frank malignancy in those with high risk benign/precursor conditions. The Radiation Epidemiology and Biostatistics Branches of the NCI propose to evaluate the contribution of inherited genetic variation to benign pre-malignant breast conditions, and to subsequent breast cancer risk in women diagnosed with such conditions, in the Breast Cancer Serum Bank, a unique biospecimen resource housed at NCI since 1995. Premenopausal participants (N=2632) biopsied at an average age of 27 in 1977-1987, (many diagnosed with high risk benign breast conditions (moderate/florid breast hyperplasia and atypia)) were interviewed and provided a blood sample. Participant biopsy reports will be obtained for review and recoding, and participants will be traced for vital status and breast cancer development (expected n = 240 cases). Variants in genes related to hormone metabolism and cell signaling, processes implicated in the development of premalignant breast conditions, and in genes associated with cell cycle control and apoptosis, and thus possibly related to progression to breast cancer among women with premalignant breast conditions will be assessed at the NCI Central Genotyping Facility. We have a remarkable opportunity in this study to address scientific questions regarding breast carcinogenesis mechanisms at relatively little cost. Greater comprehension of the influence of inherited factors on distinct steps in the biological pathway, first from normal tissue to benign high risk breast tumors, and then hence the breast cancer, should contribute to our understanding of the molecular mechanisms that shape breast cancer development, and holds promise for the discovery and delivery of sound risk-adapted interventions for women with high risk premalignant conditions.
Study design
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Potentially eligible premenopausal women include 2636 who did not have a previous or concurrent (within 60 days) diagnosis of breast cancer at the time of initial benign breast biopsy (study entry) and who have at least 4 mls of serum stored in the Frederick biorepository.
- Of those 2636, four women have a code indicating "refused study" in the "follow-up" variable, and despite evidence of their consent to the original study, will be omitted from all future use of study data or specimens.
- Participants also will be required to be Caucasian or African American (2599 or 98.6%), and to have a pathology report successfully retrieved from a participating hospital for review.
- All sample sizes subsequently cited in the text take these inclusion criteria into account, and those cited for objective 2 also incorporate adjustment for loss to follow-up.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 Mar 2009.
- Background: PubMed 9563877Alle KM, Henshall SM, Field AS, Sutherland RL. Cyclin D1 protein is overexpressed in hyperplasia and intraductal carcinoma of the breast. Clin Cancer Res. 1998 Apr;4(4):847-54.
- Background: PubMed 9214613Blomeke B, Bennett WP, Harris CC, Shields PG. Serum, plasma and paraffin-embedded tissues as sources of DNA for studying cancer susceptibility genes. Carcinogenesis. 1997 Jun;18(6):1271-5. doi: 10.1093/carcin/18.6.1271.
- Background: PubMed 1635085Boyd NF, Jensen HM, Cooke G, Han HL. Relationship between mammographic and histological risk factors for breast cancer. J Natl Cancer Inst. 1992 Aug 5;84(15):1170-9. doi: 10.1093/jnci/84.15.1170.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 National Cancer Institute (NCI) 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 0 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: finished, as of the sponsor's last update on 13 Mar 2009. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339248, which also lists 3 linked publications.
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 Mar 2009.