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Germline Alterations of Tumor Susceptibility Genes in New York Cancer Patients

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ClinicalTrials.gov Identifier: NCT00579514
Recruitment Status : Recruiting
First Posted : December 24, 2007
Last Update Posted : April 2, 2020
Sponsor:
Collaborators:
Columbia University
Weill Medical College of Cornell University
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief 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. This is an exploratory study designed to generate hypotheses for further research.

Condition or disease Intervention/treatment Phase
Breast Cancer Bladder Cancer Kidney Cancer Colon Cancer Prostate Cancer Lung Cancer Ovarian Cancer Genetic: PCR/PCR/LDR Strategy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Germline Alterations of Tumor Susceptibility Genes in New York Cancer Patients
Study Start Date : March 2000
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
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".
 Genetic: PCR/PCR/LDR Strategy
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.
Placebo Comparator: 2
Controls will be volunteer blood donors from the New York Blood Center as well as normal volunteers from other AMDeC sites.
 Genetic: PCR/PCR/LDR Strategy
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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. [ Time Frame: 20 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579514


Contacts
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Contact: Kenneth Offit, MD 646-888-4067

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Kenneth Offit, MD    646-888-4067      
Principal Investigator: Kenneth Offit, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Columbia University
Weill Medical College of Cornell University
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Kenneth Offit, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00579514    
Other Study ID Numbers: 00-014
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Kidney Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Urologic Neoplasms
Urologic Diseases
Kidney Diseases