NCT00340457

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,424

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2001

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2001

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2007

Completed
8.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

5.2 years

First QC Date

June 19, 2006

Last Update Submit

December 30, 2020

Conditions

Kidney CancerRenal Cell Carcinoma

Keywords

Case-Control StudyRenal Cell CarcinomaKidney CancerDietOccupation

Study Arms (2)

Cases

African American patients with renal cancer from two geographic areas of the US

Controls

African American participants without renal cancer from two geographic areas of the US

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cases and controls are residents of Chicago (Cook County), IL and Detroit (Wayne, Oakland, Macomb Counties), MI.

You may qualify if:

  • 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.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Related Publications (3)

  • Bergstrom A, Moradi T, Lindblad P, Nyren 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. doi: 10.1002/(sici)1097-0215(19991008)83:23.0.co;2-6.

    PMID: 10471525BACKGROUND

  • Brauch H, Weirich G, Hornauer MA, Storkel S, Wohl T, Bruning T. Trichloroethylene exposure and specific somatic mutations in patients with renal cell carcinoma. J Natl Cancer Inst. 1999 May 19;91(10):854-61. doi: 10.1093/jnci/91.10.854.

    PMID: 10340905BACKGROUND

  • Bruning 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. doi: 10.1007/s002040050432.

    PMID: 9285043BACKGROUND

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Mark P Purdue, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

November 16, 2001

Primary Completion

January 31, 2007

Study Completion

January 1, 2016

Last Updated

December 31, 2020

Record last verified: 2020-12

Locations

US(2)