Breast CancerNCT00445562
Blood Sample Collection and Health Information Collection From Patients With Invasive Breast Cancer and Their Brothers and Sisters
An observational study of Breast Cancer, run by GenBasix Incorporated at 1 site in United States.
Trial summary
RATIONALE: Collecting blood samples and health information from patients with invasive breast cancer and from their brothers and sisters over time may help the study of cancer in the future. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- biologic sample preservation procedure and informational intervention
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Dec 2004
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Pathologically confirmed invasive breast cancer (patient)
- No ductal carcinoma in situ
- Affected OR unaffected sibling
- Affected sibling must have had (or currently has) breast cancer only
- Unaffected sibling must be female
- No deceased siblings
- Must be a full-blood related sibling
- Patients receiving treatment on clinical trial ECOG-E1Y97 or ECOG-E3Y92 are not eligible
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
GenBasix Incorporated
Duarte, California, 91010
Richard A. Shapiro, MD, 800-248-4908
About this study
Official title: Breast Cancer Siblings Database
RATIONALE: Collecting blood samples and health information from patients with invasive breast cancer and from their brothers and sisters over time may help the study of cancer in the future.
PURPOSE: This study is collecting blood samples and health information over time from patients with invasive breast cancer and from their brothers and sisters.
Read the detailed description
OBJECTIVES:
- Collect blood samples and medical and background information from patients with invasive breast cancer and their affected or unaffected siblings.
OUTLINE: Patients and their siblings undergo blood collection. They also complete medical and background questionnaires.
Patients and their siblings are followed annually for 5 years.
PROJECTED ACCRUAL: A total of 1,000 patients and siblings will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- biologic sample preservation procedure, informational intervention
- Keywords
- male breast cancer, recurrent breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologic sample preservation procedureOther
informational interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of blood samples and medical and background information
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2007 (estimated)
- Study startJan 2001
- Primary completionDec 2004
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.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GenBasix Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard A. Shapiro, MD, Study chair, GenBasix Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445562
- Sponsor's protocol ID
- GENBASIX-00127
- Other IDs
- CDR0000529353, GENBASIX-1024122
- Status last verified
- Jul 2009
- First submitted
- 7 Mar 2007
- Last updated
- 10 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Siblings Database
- ClinicalTrials.gov ID
- NCT00445562
- Acronym / sponsor ID
- GENBASIX-00127
- Conditions
- Breast Cancer
- Keywords
- male breast cancer, recurrent breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- GenBasix IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Primary completion
- Dec 2004 (actual)
- First posted
- 9 Mar 2007 (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: Collecting blood samples and health information from patients with invasive breast cancer and from their brothers and sisters over time may help the study of cancer in the future.
PURPOSE: This study is collecting blood samples and health information over time from patients with invasive breast cancer and from their brothers and sisters.
Detailed description
OBJECTIVES:
- Collect blood samples and medical and background information from patients with invasive breast cancer and their affected or unaffected siblings.
OUTLINE: Patients and their siblings undergo blood collection. They also complete medical and background questionnaires.
Patients and their siblings are followed annually for 5 years.
PROJECTED ACCRUAL: A total of 1,000 patients and siblings will be accrued for this study.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| biologic sample preservation procedure | Other | – |
| informational intervention | Other | – |
Primary outcome
Collection of blood samples and medical and background information
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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.
Richard A. Shapiro, MD study chair
GenBasix Incorporated
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 GenBasix Incorporated 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: status not confirmed, as of the sponsor's last update on 10 Jul 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of blood samples and medical and background information. 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 10 Jul 2013.