Case-Control Study of Renal Cell Cancer Among Caucasions and African Americans in the United States

Renal Cell Carcinoma Clinical Trial

Official title:

Case-Control Study of Renal Cell Cancer Among Caucasians and African Americans in the United States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00340457
• Other study ID #: 999902051
• Secondary ID: 02-C-N051
• Status: Completed
• Start date: November 16, 2001
• Est. completion date: January 1, 2016

Study information

• Verified date: December 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Incidence rates of renal cell cancer have increased rapidly in the U.S. and other countries. In particular, rates among African Americans have risen more sharply than any other cancer site. We propose to conduct a population-based case-control study of renal cell cancer in areas of the U.S. with a high proportion of African American residents. We will include two study centers and one data coordinating center and will recruit study participants over a period of four years. We plan to conduct in-person interviews with 2,100 cases (1,400 whites and 700 blacks) and 2,800 controls (1,400 each of whites and blacks) to elicit information on demographic background and history of exposures. A 40 ml blood sample will be collected from living cases and controls to measure certain environmental exposures and for genetic analyses. Two buccal cell samples will be collected from living cases and controls for genetic analyses. Tumor tissue blocks will be collected from as many cases as possible for assays of tumor mutations. Diagnostic slides will be collected for standardized reclassification of tumors into clear cell, papillary, and other histologic subtypes. Medical records for all cases will be reviewed for health insurance coverage, concomitant conditions, presenting symptoms, tumor stage, size and grade, and methods leading to diagnosis of renal cell cancer.

Description:

Incidence rates of renal cell cancer have increased rapidly in the U.S. and other countries. In particular, rates among African Americans have risen more sharply than any other cancer site. We propose to conduct a population-based case-control study of renal cell cancer two areas of the U.S. with a high proportion of African American residents: Detroit, Michigan (Wayne State University), and Chicago, Illinois (University of Illinois at Chicago). Westat, Inc. is the coordinating center. Participants are being recruited over a period of four years. A total of 2,100 cases (1,400 Caucasian Americans and 700 African Americans) and 2,800 controls (1,400 each of Caucasian and African Americans) will be recruited. In-person interviews are conducted with cases and controls to elicit information on demographic background and history of exposures. A 40 ml blood sample and a buccal cell sample are collected from cases and controls for genetic analyses. Tumor tissue blocks will be collected from as many cases as possible for assays of tumor mutations. Diagnostic slides will be collected for standardized reclassification of tumors into clear cell, papillary, and other histologic subtypes. Medical records for all cases will be reviewed for presenting symptoms, tumor stage, size and grade, and methods leading to diagnosis of renal cell cancer. Telephone interviews are conducted with the nest-of-kin of eligible cases who died before we could interview them. Permission is being sought from the next-of-kin to assess the case's medical records and obtain tumor tissue samples.

Other known NCT identifiers

• NCT00546338
• NCT01338220

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2424
• Est. completion date: January 1, 2016
• Est. primary completion date: January 31, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

• INCLUSION CRITERIA - CASES:

Residents of the study areas who are diagnosed with histologically confirmed renal cell carcinoma at ages 20 to 79 years over a four year study will be potentially eligible for the study. In addition, only eligible patients who are mentally/physically able to provide informed consent and undergo interviews will be approached for participation. INCLUSION CRITERIA - CONTROLS: Population-based controls will be frequency-matched to the cases by study center, race, age and sex, at the ratio of one control per case for non-African Americans and two controls per case for African Americans. Controls aged 65 years and older will be identified from Health Care Financing Administration (HCFA) files. Controls under age 65 years will be identified from residents of the study areas by random telephone digit dialing (RDD).

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Renal Cell Carcinoma

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Wayne State University	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bergström A, Moradi T, Lindblad P, Nyrén O, Adami HO, Wolk A. Occupational physical activity and renal cell cancer: a nationwide cohort study in Sweden. Int J Cancer. 1999 Oct 8;83(2):186-91. — View Citation

Brauch H, Weirich G, Hornauer MA, Störkel S, Wöhl T, Brüning T. Trichloroethylene exposure and specific somatic mutations in patients with renal cell carcinoma. J Natl Cancer Inst. 1999 May 19;91(10):854-61. — View Citation

Brüning T, Lammert M, Kempkes M, Thier R, Golka K, Bolt HM. Influence of polymorphisms of GSTM1 and GSTT1 for risk of renal cell cancer in workers with long-term high occupational exposure to trichloroethene. Arch Toxicol. 1997;71(9):596-9. — View Citation