Breast CancerNCT00590109
Germline BRCA1 and BRCA2 Mutations in Jewish Women Affected by Breast Cancer
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this project is to further characterize inherited predisposition to breast cancer mediated by specific BRCA alleles (BRACA1 185delAG and 5382insC; BRCA2 6174delT) among Jewish women. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Blood test and Questionnaire
- How many people
- 383 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1997to 22 Dec 2021
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A list of Jewish women diagnosed with breast cancer at Memorial Hospital after January 1994 will be generated from the hospital database. Patients that meet the study criteria will have a letter sent to their oncologist asking permission to invite the patient to participate in a study.
Who may be able to join
- Patients are eligible for the study if they are over 18 years of age, identify their ancestry as Jewish (both Sephardic and Ashkenazi Jews are eligible), have or have had a diagnosis of breast cancer, and are able to give informed consent.
- Relatives, age 18 or older, of the patients who meet eligibility criteria above and are found to have a specific BRCA1 or BRCA2 mutation if they are able to give informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this project is to further characterize inherited predisposition to breast cancer mediated by specific BRCA alleles (BRACA1 185delAG and 5382insC; BRCA2 6174delT) among Jewish women.
- Conditions
- Breast Cancer
- Being tested
- Blood test, Questionnaire
- Keywords
- Breast Cancer, Jewish, BRCA1, BRCA2, 97-029
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
subjects will provide one 8ml blood sample drawn into one ACD tube and 16ml of blood drawn into two EDTA (purple top) tubes.
QuestionnaireOther
A questionnaire encompassing medical, environmental exposure, and reproductive history.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Other: Blood test; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
to further characterize inherited predisposition to breast cancer mediated by specific BRCA alleles among Jewish women.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startMar 1997
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
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 Memorial Sloan Kettering 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sarah Lawrence College, University of Washington
- Responsible party
- Sponsor
- Investigators
- Kenneth Offit, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590109
- Sponsor's protocol ID
- 97-029
- Other IDs
- CA08748
- Status last verified
- Dec 2021
- First submitted
- 26 Dec 2007
- Last updated
- 28 Dec 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Germline BRCA1 and BRCA2 Mutations in Jewish Women Affected by Breast Cancer
- ClinicalTrials.gov ID
- NCT00590109
- Acronym / sponsor ID
- 97-029
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Jewish, BRCA1, BRCA2, 97-029
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Sarah Lawrence College, University of Washington
- Study start
- Mar 1997
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 10 Jan 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.
The purpose of this project is to further characterize inherited predisposition to breast cancer mediated by specific BRCA alleles (BRACA1 185delAG and 5382insC; BRCA2 6174delT) among Jewish women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Blood test, Other: Questionnaire |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A list of Jewish women diagnosed with breast cancer at Memorial Hospital after January 1994 will be generated from the hospital database. Patients that meet the study criteria will have a letter sent to their oncologist asking permission to invite the patient to participate in a study.
Key inclusion criteria (2 listed)
- Patients are eligible for the study if they are over 18 years of age, identify their ancestry as Jewish (both Sephardic and Ashkenazi Jews are eligible), have or have had a diagnosis of breast cancer, and are able to give informed consent.
- Relatives, age 18 or older, of the patients who meet eligibility criteria above and are found to have a specific BRCA1 or BRCA2 mutation if they are able to give informed consent.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testsubjects will provide one 8ml blood sample drawn into one ACD tube and 16ml of blood drawn into two EDTA (purple top) tubes. | Other | 1 |
| QuestionnaireA questionnaire encompassing medical, environmental exposure, and reproductive history. | Other | 1 |
Primary outcome
to further characterize inherited predisposition to breast cancer mediated by specific BRCA alleles among Jewish women.
Time frame: through study completion, an average of 1 year
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 28 Dec 2021.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Kenneth Offit, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Memorial Sloan Kettering Cancer Center 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 2 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 28 Dec 2021. 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?
to further characterize inherited predisposition to breast cancer mediated by specific BRCA alleles among Jewish women. (time frame: through study completion, an average of 1 year). 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 28 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.