Breast CancerNCT00766454
Studying Urine and Blood Samples in Women With Newly Diagnosed Breast Cancer
An observational study of Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
RATIONALE: Studying samples of urine and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This study is looking at urine and blood samples in women with newly diagnosed breast cancer. Read more about this study
- Who is it for?
- Ages Up to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- DNA analysis, mutation analysis and polymorphism analysis
- Type of treatment
- Surgery or procedure
- How many people
- 1,104 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1998to Jan 2010
- 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 Up to 120 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Those with newly diagnosed breast cancer who are planning to undergo a diagnostic biopsy or surgery.
Who may be able to join
- Newly diagnosed breast cancer
- Planning to undergo a diagnostic biopsy or surgery
- Must have tumor tissue available
- Hormone receptor status not specified
- More than 6 months since prior chemotherapy or radiotherapy
- Pre- or post-menopausal
Who cannot join
- -Psychiatric history that would preclude giving informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: Metabolic Genotypes and Oncogenic Damage in Breast Cancer
RATIONALE: Studying samples of urine and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This study is looking at urine and blood samples in women with newly diagnosed breast cancer.
Read the detailed description
OBJECTIVES:
- To determine the association between the genotype for 4 metabolic enzymes (e.g., CYP1A1, GSTM, GSTT, and GSTP) in women with newly diagnosed breast cancer that play key roles in the metabolism of environmental human carcinogens and the risk of breast cancer development.
OUTLINE: Urine and blood samples are collected for DNA, mutation, and polymorphism analysis. The biological samples may be stored and used for future research.
Patients complete a Baseline Questionnaire to collect basic risk/exposure information, including demographic factors (e.g., age, weight, height, and body mass index), menstrual/reproductive history, medical history, medication use, smoking history, alcohol consumption, exposure to chest x-ray, and family history of breast cancer in first-degree relatives. Patients also complete a Second Hand Smoke Questionnaire to collect information on cigarette smoking history and second hand smoke exposure and a Food Frequency Questionnaire to collect information on the frequency of use of specific fruits and vegetables (e.g., cruciferous vegetables) and to estimate usual dietary intake of 33 nutrients during the past year (e.g., total fat, saturated fat, oleic fat, linoleic fat, carbohydrates, protein, vitamins [e.g., A, B1, B2, niacin, B6, folate, C, and E], minerals [e.g., calcium, magnesium, iron, and zinc], electrolytes [e.g., sodium and potassium], and dietary fiber). Patients' medical charts are also reviewed to collect information on age, gender, ethnic background, medical history, and medical care.
- Conditions
- Breast Cancer
- Being tested
- DNA analysis, mutation analysis, polymorphism analysis, laboratory biomarker analysis, medical chart review
- Keywords
- 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.
DNA analysisGenetic
mutation analysisGenetic
polymorphism analysisGenetic
laboratory biomarker analysisOther
medical chart reviewOther
questionnaire administrationOther
evaluation of cancer risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between the genotype for 4 metabolic enzymes (e.g., CYP1A1, GSTM, GSTT, and GSTP) that play key roles in the metabolism of environmental human carcinogens and the risk of breast cancer development
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startNov 1998
- Primary completionJan 2010
- Study completionJan 2010
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 Wake Forest University Health SciencesThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Steven A. Akman, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766454
- Sponsor's protocol ID
- CDR0000573065
- Other IDs
- P30CA012197, CCCWFU-98298, CCCWFU-BG98-278
- Status last verified
- Oct 2015
- First submitted
- 3 Oct 2008
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Genotypes and Oncogenic Damage in Breast Cancer
- ClinicalTrials.gov ID
- NCT00766454
- Acronym / sponsor ID
- CDR0000573065
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,104 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 1998
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 6 Oct 2008 (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 urine and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This study is looking at urine and blood samples in women with newly diagnosed breast cancer.
Detailed description
OBJECTIVES:
- To determine the association between the genotype for 4 metabolic enzymes (e.g., CYP1A1, GSTM, GSTT, and GSTP) in women with newly diagnosed breast cancer that play key roles in the metabolism of environmental human carcinogens and the risk of breast cancer development.
OUTLINE: Urine and blood samples are collected for DNA, mutation, and polymorphism analysis. The biological samples may be stored and used for future research.
Patients complete a Baseline Questionnaire to collect basic risk/exposure information, including demographic factors (e.g., age, weight, height, and body mass index), menstrual/reproductive history, medical history, medication use, smoking history, alcohol consumption, exposure to chest x-ray, and family history of breast cancer in first-degree relatives. Patients also complete a Second Hand Smoke Questionnaire to collect information on cigarette smoking history and second hand smoke exposure and a Food Frequency Questionnaire to collect information on the frequency of use of specific fruits and vegetables (e.g., cruciferous vegetables) and to estimate usual dietary intake of 33 nutrients during the past year (e.g., total fat, saturated fat, oleic fat, linoleic fat, carbohydrates, protein, vitamins [e.g., A, B1, B2, niacin, B6, folate, C, and E], minerals [e.g., calcium, magnesium, iron, and zinc], electrolytes [e.g., sodium and potassium], and dietary fiber). Patients' medical charts are also reviewed to collect information on age, gender, ethnic background, medical history, and medical care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Those with newly diagnosed breast cancer who are planning to undergo a diagnostic biopsy or surgery.
Key inclusion criteria (6 listed)
- Newly diagnosed breast cancer
- Planning to undergo a diagnostic biopsy or surgery
- Must have tumor tissue available
- Hormone receptor status not specified
- More than 6 months since prior chemotherapy or radiotherapy
Key exclusion criteria (1 listed)
- -Psychiatric history that would preclude giving informed consent
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 |
|---|---|---|
| DNA analysis | Genetic | – |
| mutation analysis | Genetic | – |
| polymorphism analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| medical chart review | Other | – |
| questionnaire administration | Other | – |
| evaluation of cancer risk factors | Procedure or surgery | – |
Primary outcome
Association between the genotype for 4 metabolic enzymes (e.g., CYP1A1, GSTM, GSTT, and GSTP) that play key roles in the metabolism of environmental human carcinogens and the risk of breast cancer development
Time frame: Day 1
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 1 Aug 2017.
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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.
Steven A. Akman, MD study chair
Wake Forest University Health Sciences
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 Wake Forest University Health Sciences 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 6 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: finished, as of the sponsor's last update on 1 Aug 2017. 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?
Association between the genotype for 4 metabolic enzymes (e.g., CYP1A1, GSTM, GSTT, and GSTP) that play key roles in the metabolism of environmental human carcinogens and the risk of breast cancer development (time frame: Day 1). 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 1 Aug 2017.