Breast CancerNCT00579514
Germline Alterations of Tumor Susceptibility Genes in New York Cancer Patients
A study testing PCR/PCR/LDR Strategy in people with Breast Cancer and Bladder Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The basic premise of this research proposal is to determine whether there is any significant association between germline polymorphisms and cancers of colon, bladder, breast, testicular, prostate, ovaries, kidney, lung, lymphoid organs, and head and neck. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Bladder Cancer, Kidney Cancer
- What is being tested?
- PCR/PCR/LDR Strategy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21,081 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2000to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients with a histologic diagnosis of cancer of the colon, breast, bladder, kidney, testicles, lungs, prostate, head and neck, or lymphoid organs, who have donated a diagnostic blood sample as either an inpatient or outpatient at MSKCC.
- All patients who have two or more histologic diagnoses of the same primary tumor type involving the above sites.
- Patients of Ashkenazi Jewish ancestry with a histologic diagnosis of cancer of any type.
- Samples ascertained as part of protocol 98-024A(1) are also eligible for ascertainment in this study.
Who cannot join
- MSKCC patients without a histologic diagnosis of cancer of the breast, bladder, kidney, colon, testicles, lungs, prostate, or lymphoid malignancy (including all types of lymphoma) will not be eligible for the AMDeC sponsored component of the study.
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 basic premise of this research proposal is to determine whether there is any significant association between germline polymorphisms and cancers of colon, bladder, breast, testicular, prostate, ovaries, kidney, lung, lymphoid organs, and head and neck. This is an exploratory study designed to generate hypotheses for further research.
Read the detailed description
To establish significant correlations between genetic polymorphisms and cancer, a largescale, systematic comparison of genetic alterations utilizing a case-control methodology is proposed. To date, such studies have been limited due to the large number of samples necessary for obtaining statistical significance, and the lack of rapid and accurate methods to screen for genetic polymorphisms. We propose to utilize an anonymized design to obtain DNA from residual material from routine diagnostic blood tests, to link these samples to a limited set of clinical variables, and to test for the frequency of candidate low-penetrance cancer susceptibility alleles. These data will be combined with similar data from a control group of age- and ethnically-matched volunteers for a related cohort study to be conducted separately. Polymorphisms to be screened for include those involving the genes PTEN, APC, TGF βR-I, BLM, CHK2, a p85 phosphoprotein, ATM, ER, PR, MCP-1, MPIF, CCR2/5, CCR3, and SULT1A1. Cancers to be included are breast, bladder, kidney,colon, testicular, lung, prostate, ovarian, lymphoid neoplasms, and head and neck carcinomas. Genes with SNPs known to be relevant for either the development or treatment of lymphoid malignancies will also be targeted. Specifically, candidate genes will be selected from 1) cytokine signaling, 2) DNA repair, and 3) apoptosis regulatory pathways.
- Conditions
- Breast Cancer, Bladder Cancer, Kidney Cancer, Colon Cancer, Prostate Cancer, Lung Cancer
- Being tested
- PCR/PCR/LDR Strategy
- Medical subject headings
- Breast Neoplasms, Urinary Bladder Neoplasms, Kidney Neoplasms, Colonic Neoplasms, Prostatic Neoplasms, Lung Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR/PCR/LDR StrategyGenetic
Evaluate the extent to which polymorphisms in BRCA1, BRCA2, PTEN, T β R1, TGF β-1, DNA repair genes (including ATM and CHK2), APC, ER, PR, MCP-1, MPIF, CCR2/5 and CCR3 are correlated with cancer incidence. Candidate genes will also be selected from 1) cytokine signaling and 2) apoptosis regulatory pathways.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | All incident second primary cancers of colon, breast, bladder, kidney, prostate, ovarian cancer lung cancer and lymphoid cancer diagnosed between 1999 and present will be included in the secondary design to compare second primary cancer "cases" and first primary "controls". Receives: Genetic: PCR/PCR/LDR Strategy |
| 2 | Placebo comparator | Controls will be volunteer blood donors from the New York Blood Center as well as normal volunteers from other AMDeC sites. Receives: Genetic: PCR/PCR/LDR Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect anonymized germline DNA from patients with breast, bladder, kidney, lung, colon, testicular, prostate, lymphoid, ovarian or head and neck cancers, as well as patients with multiple primary cancers, from select New York City ethnic groups.
Measured: 20 years
Secondary outcomes (1)
To analyze DNA samples from matched non-cancer individuals of the same ethnic groups available as part of the AMDeC-sponsored New York Cancer Study.
Measured: 20 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 startMar 2000
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21,081 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Weill Medical College of Cornell University, Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Kenneth Offit, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579514
- Sponsor's protocol ID
- 00-014
- Status last verified
- Apr 2026
- First submitted
- 20 Dec 2007
- Last updated
- 7 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Germline Alterations of Tumor Susceptibility Genes in New York Cancer Patients
- ClinicalTrials.gov ID
- NCT00579514
- Acronym / sponsor ID
- 00-014
- Conditions
- Breast Cancer, Bladder Cancer, Kidney Cancer, Colon Cancer, Prostate Cancer, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21,081 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Columbia University, Weill Medical College of Cornell University, Icahn School of Medicine at Mount Sinai
- Study start
- Mar 2000
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- 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.
The basic premise of this research proposal is to determine whether there is any significant association between germline polymorphisms and cancers of colon, bladder, breast, testicular, prostate, ovaries, kidney, lung, lymphoid organs, and head and neck. This is an exploratory study designed to generate hypotheses for further research.
Detailed description
To establish significant correlations between genetic polymorphisms and cancer, a largescale, systematic comparison of genetic alterations utilizing a case-control methodology is proposed. To date, such studies have been limited due to the large number of samples necessary for obtaining statistical significance, and the lack of rapid and accurate methods to screen for genetic polymorphisms. We propose to utilize an anonymized design to obtain DNA from residual material from routine diagnostic blood tests, to link these samples to a limited set of clinical variables, and to test for the frequency of candidate low-penetrance cancer susceptibility alleles. These data will be combined with similar data from a control group of age- and ethnically-matched volunteers for a related cohort study to be conducted separately. Polymorphisms to be screened for include those involving the genes PTEN, APC, TGF βR-I, BLM, CHK2, a p85 phosphoprotein, ATM, ER, PR, MCP-1, MPIF, CCR2/5, CCR3, and SULT1A1. Cancers to be included are breast, bladder, kidney,colon, testicular, lung, prostate, ovarian, lymphoid neoplasms, and head and neck carcinomas. Genes with SNPs known to be relevant for either the development or treatment of lymphoid malignancies will also be targeted. Specifically, candidate genes will be selected from 1) cytokine signaling, 2) DNA repair, and 3) apoptosis regulatory pathways.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Genetic: PCR/PCR/LDR StrategyAll incident second primary cancers of colon, breast, bladder, kidney, prostate, ovarian cancer lung cancer and lymphoid cancer diagnosed between 1999 and present will be included in the secondary design to compare second primary cancer "cases" and first primary "controls". |
| 2 | Placebo comparator | Genetic: PCR/PCR/LDR StrategyControls will be volunteer blood donors from the New York Blood Center as well as normal volunteers from other AMDeC sites. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a histologic diagnosis of cancer of the colon, breast, bladder, kidney, testicles, lungs, prostate, head and neck, or lymphoid organs, who have donated a diagnostic blood sample as either an inpatient or outpatient at MSKCC.
- All patients who have two or more histologic diagnoses of the same primary tumor type involving the above sites.
- Patients of Ashkenazi Jewish ancestry with a histologic diagnosis of cancer of any type.
- Samples ascertained as part of protocol 98-024A(1) are also eligible for ascertainment in this study.
Key exclusion criteria (1 listed)
- MSKCC patients without a histologic diagnosis of cancer of the breast, bladder, kidney, colon, testicles, lungs, prostate, or lymphoid malignancy (including all types of lymphoma) will not be eligible for the AMDeC sponsored component of the study.
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 |
|---|---|---|
| PCR/PCR/LDR StrategyEvaluate the extent to which polymorphisms in BRCA1, BRCA2, PTEN, T β R1, TGF β-1, DNA repair genes (including ATM and CHK2), APC, ER, PR, MCP-1, MPIF, CCR2/5 and CCR3 are correlated with cancer incidence. Candidate genes will also be selected from 1) cytokine signaling and 2) apoptosis regulatory pathways. | Genetic | 1, 2 |
Primary outcome
To collect anonymized germline DNA from patients with breast, bladder, kidney, lung, colon, testicular, prostate, lymphoid, ovarian or head and neck cancers, as well as patients with multiple primary cancers, from select New York City ethnic groups.
Time frame: 20 years
1 secondary outcome
To analyze DNA samples from matched non-cancer individuals of the same ethnic groups available as part of the AMDeC-sponsored New York Cancer Study.
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- 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?
A study testing PCR/PCR/LDR Strategy in people with Breast Cancer and Bladder 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 4 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: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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 collect anonymized germline DNA from patients with breast, bladder, kidney, lung, colon, testicular, prostate, lymphoid, ovarian or head and neck cancers, as well as patients with multiple primary cancers, from select New York City ethnic groups. (time frame: 20 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 7 Apr 2026.