Germline Alterations of Tumor Susceptibility Genes in New York Cancer Patients

NCT00579514 | Active Not Recruiting

• 1 other identifier: 00-014
• Study Type: interventional
• Target: 21,081
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Bladder Cancer; Kidney Cancer; Colon Cancer; Prostate Cancer; Lung Cancer; Ovarian Cancer

Outcome Measures

Primary Outcomes (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.

  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.

  20 years

Study Arms (2)

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".

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.

Genetic: PCR/PCR/LDR Strategy

Interventions

PCR/PCR/LDR Strategy GENETIC

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.

1; 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Columbia University: collaborator
• Weill Medical College of Cornell University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Urinary Bladder Neoplasms; Kidney Neoplasms; Colonic Neoplasms; Prostatic Neoplasms; Lung Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Kidney Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Kenneth Offit, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 24, 2007
• Study Start: March 1, 2000
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-04

Locations

US (1)