Kidney CancerNCT00340457
Case-Control Study of Renal Cell Cancer Among Caucasions and African Americans in the United States
An observational study of Kidney Cancer and Renal Cell Carcinoma, run by National Cancer Institute (NCI) at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Kidney Cancer, Renal Cell Carcinoma
- How many people
- 2,424 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Nov 2001to 1 Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cases and controls are residents of Chicago (Cook County), IL and Detroit (Wayne, Oakland, Macomb Counties), MI.
Who may be able to join
- 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).
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Illinois at Chicago
Chicago, Illinois, 60612
Wayne State University
Detroit, Michigan, 48201
About this study
Official title: Case-Control Study of Renal Cell Cancer Among Caucasians and African Americans in the United States
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.
Read the detailed 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.
- Conditions
- Kidney Cancer, Renal Cell Carcinoma
- Keywords
- Case-Control Study, Renal Cell Carcinoma, Kidney Cancer, Diet, Occupation
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start16 Nov 2001
- Primary completion31 Jan 2007
- Study completion1 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,424 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark P Purdue, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340457
- Sponsor's protocol ID
- 999902051
- Other IDs
- 02-C-N051
- Status last verified
- Dec 2020
- First submitted
- 19 Jun 2006
- Last updated
- 31 Dec 2020
- Results posted
- No
Publications
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.
PubMed 10471525Brauch 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.
PubMed 10340905Bruning 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.
PubMed 9285043
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-Control Study of Renal Cell Cancer Among Caucasians and African Americans in the United States
- ClinicalTrials.gov ID
- NCT00340457
- Acronym / sponsor ID
- 999902051
- Conditions
- Kidney Cancer, Renal Cell Carcinoma
- Keywords
- Case-Control Study, Renal Cell Carcinoma, Kidney Cancer, Diet, Occupation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,424 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 16 Nov 2001 (actual)
- Primary completion
- 31 Jan 2007 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 21 Jun 2006 (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.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases and controls are residents of Chicago (Cook County), IL and Detroit (Wayne, Oakland, Macomb Counties), MI.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Background: PubMed 10471525Bergstrom 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.
- Background: PubMed 10340905Brauch 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.
- Background: PubMed 9285043Bruning 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.
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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.
Mark P Purdue, M.D. principal investigator
National Cancer Institute (NCI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Cancer and Renal Cell Carcinoma, run by National Cancer Institute (NCI) at 2 sites 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 5 inclusion and 0 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: finished, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00340457, which also lists 3 linked publications.
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 31 Dec 2020.