Breast CancerNCT00580021
Clinical Outcomes in Hereditary Cancer
An observational study of Breast Cancer and Pancreatic Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Compare the clinical characteristics and post-surgical outcomes (overall survival)of pancreatic cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Pancreatic Cancer
- What is being tested?
- Genotyping
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jan 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The subjects will be individuals with the disease of interest during the time period of interest who described their religious preference at the time of registration to be Jewish.
Who may be able to join
- Included in DB0363-03
- Jewish religious preference at registration
- Archival material available for testing
- Adequate post-surgical follow-up
- Jewish religious preference at registration
- Archival material available for testing
- Adequate follow-up to determine time to progression
Who cannot join
- -Subjects will not be included in the analyses if a DNA sample cannot be obtained.
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
Compare the clinical characteristics and post-surgical outcomes (overall survival)of pancreatic cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 .
Compare the clinical characteristics and outcomes (time to progression) of breast cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 receiving paclitaxel chemotherapy for metastatic disease.
Read the detailed description
Compare the clinical characteristics and post-surgical outcomes (overall survival)of pancreatic cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 .
Compare the clinical characteristics and outcomes (time to progression) of breast cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 receiving paclitaxel chemotherapy for metastatic disease.
- Conditions
- Breast Cancer, Pancreatic Cancer
- Being tested
- Genotyping
- Keywords
- Ashkenazi ancestry, mutations in BRCA1 or BRCA2, Breast Cancer, Pancreatic Cancer
- Medical subject headings
- Breast Neoplasms, Pancreatic Neoplasms, Fanconi Anemia, Complementation Group D1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenotypingOther
Samples for DNA extraction will be shaved from archival paraffin-embedded tissue blocks (using normal lymph node preferentially)and placed in appropriate receptacles labeled only with the subject unique study number. This material will be transported to the genotyping laboratory, where it will be stored until the clinical record abstraction is complete. Briefly, DNA will be extracted from the archive paraffin-embedded material using standard protocols and the samples will be analyzed for the presence of the Ashkenazi BRCA founder mutations using either PCR-based or gel-electrophoresis-based approaches.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with breast and pancreas cancer. Receives: Other: Genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall objective of the protocol is to examine the hypothesis that hereditary cancers are distinct in clinical characteristics and outcome from those that arise in the absence of a known predisposition.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startJan 2006
- Primary completionJan 2016
- Study completionJan 2016
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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Robson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580021
- Sponsor's protocol ID
- 06-004
- Status last verified
- Jan 2016
- First submitted
- 19 Dec 2007
- Last updated
- 28 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes in Hereditary Cancer
- ClinicalTrials.gov ID
- NCT00580021
- Acronym / sponsor ID
- 06-004
- Conditions
- Breast Cancer, Pancreatic Cancer
- Keywords
- Ashkenazi ancestry, mutations in BRCA1 or BRCA2, Breast Cancer, Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Dec 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.
Compare the clinical characteristics and post-surgical outcomes (overall survival)of pancreatic cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 .
Compare the clinical characteristics and outcomes (time to progression) of breast cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 receiving paclitaxel chemotherapy for metastatic disease.
Detailed description
Compare the clinical characteristics and post-surgical outcomes (overall survival)of pancreatic cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 .
Compare the clinical characteristics and outcomes (time to progression) of breast cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 receiving paclitaxel chemotherapy for metastatic disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: GenotypingPatients with breast and pancreas cancer. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The subjects will be individuals with the disease of interest during the time period of interest who described their religious preference at the time of registration to be Jewish.
Key inclusion criteria (7 listed)
- Included in DB0363-03
- Jewish religious preference at registration
- Archival material available for testing
- Adequate post-surgical follow-up
- Jewish religious preference at registration
Key exclusion criteria (1 listed)
- -Subjects will not be included in the analyses if a DNA sample cannot be obtained.
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 |
|---|---|---|
| GenotypingSamples for DNA extraction will be shaved from archival paraffin-embedded tissue blocks (using normal lymph node preferentially)and placed in appropriate receptacles labeled only with the subject unique study number. This material will be transported to the genotyping laboratory, where it will be stored until the clinical record abstraction is complete. Briefly, DNA will be extracted from the archive paraffin-embedded material using standard protocols and the samples will be analyzed for the presence of the Ashkenazi BRCA founder mutations using either PCR-based or gel-electrophoresis-based approaches. | Other | 1 |
Primary outcome
The overall objective of the protocol is to examine the hypothesis that hereditary cancers are distinct in clinical characteristics and outcome from those that arise in the absence of a known predisposition.
Time frame: 2 years
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 28 Jan 2016.
- 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.
Mark Robson, 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 and Pancreatic 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 7 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: withdrawn, as of the sponsor's last update on 28 Jan 2016. 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 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.
What does the primary outcome measure?
The overall objective of the protocol is to examine the hypothesis that hereditary cancers are distinct in clinical characteristics and outcome from those that arise in the absence of a known predisposition. (time frame: 2 years). 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 Jan 2016.