Interdisciplinary Case-Control Study of Bladder Cancer in Spain

Bladder Cancer Clinical Trial

Official title:

Interdisciplinary Case-Control Study of Bladder Cancer in Spain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00341861
• Other study ID #: 999999038
• Secondary ID: OH99-C-N038
• Status: Completed
• Start date: September 1, 1998
• Est. completion date: October 14, 2020

Study information

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

Clinical Trial Summary

The incidence rate of bladder cancer in the Barcelona area of Spain is almost identical to that of the U.S. Cigarette smoking has been identified as the most significant risk factor for bladder cancer, followed by occupational exposures to chemicals such as aromatic amines and their derivatives, diesel exhaust, oil mist, pesticides, and polynuclear aromatic hydrocarbons. A variety of non-occupational exposures have been suggested as potential risk factors as well, including smoking black vs. blond tobacco, dietary factors, certain medications and medical conditions, chlorination by-products in drinking water, and fluid intake. Various genetic polymorphisms also appear to affect bladder cancer risk. Research is needed to further explore hypotheses generated by previous etiologic studies of bladder cancer. An on-going study of bladder cancer survival by the Institut Municipal d'Investigacio Medica in Spain provides an excellent opportunity for NCI to perform such research. NCI will build upon the ongoing study by funding an interdisciplinary case-control component to evaluate bladder cancer risk in relation to various external factors (e.g., occupational and environmental exposure) and host factors (e.g., genetic susceptibility markers, and early effect markers). This hospital-based case-control study will involve personal interviews using a state-of-the-art, computer assisted technique, and collection of blood and toenail samples from participants.

Description:

The incidence rate of bladder cancer in the Barcelona area of Spain is almost identical to that of the U.S. Cigarette smoking has been identified as the most significant risk factor for bladder cancer, followed by occupational exposures to chemicals such as aromatic amines and their derivatives, diesel exhaust, oil mist, pesticides, and polynuclear aromatic hydrocarbons. A variety of non-occupational exposures have been suggested as potential risk factors as well, including smoking black vs. blond tobacco, dietary factors, certain medications and medical conditions, chlorination by-products in drinking water, and fluid intake. Various genetic polymorphisms also appear to affect bladder cancer risk. Research is needed to further explore hypotheses generated by previous etiologic studies of bladder cancer. An ongoing study of bladder cancer survival by the Institut Municipal d'Investigacio Medica in Spain provides an excellent opportunity for NCI to perform such research. NCI will build upon the ongoing study by funding an interdisciplinary case-control component to evaluate bladder cancer risk in relation to various external factors (e.g., occupational and environmental exposure) and host factors (e.g., genetic susceptibility marker, and early effect markers). This hospital-based case-control study will involve personal interviews using a state-of-the-art, computer-assisted technique, and collection of blood and toenail samples from participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2925
• Est. completion date: October 14, 2020
• Est. primary completion date: December 4, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

• INCLUSION CRITERIA:

All histologically confirmed cases of carcinoma of the bladder including carcinoma in situ at the 21 centers.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
Spain	Institut Municipal d'Investigacio Medica	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Agúndez JA, Martínez C, Olivera M, Ledesma MC, Ladero JM, Benítez J. Molecular analysis of the arylamine N-acetyltransferase polymorphism in a Spanish population. Clin Pharmacol Ther. 1994 Aug;56(2):202-9. — View Citation

Babu SR, Lakshmi VM, Huang GP, Zenser TV, Davis BB. Glucuronide conjugates of 4-aminobiphenyl and its N-hydroxy metabolites. pH stability and synthesis by human and dog liver. Biochem Pharmacol. 1996 Jun 28;51(12):1679-85. — View Citation

Badawi AF, Hirvonen A, Bell DA, Lang NP, Kadlubar FF. Role of aromatic amine acetyltransferases, NAT1 and NAT2, in carcinogen-DNA adduct formation in the human urinary bladder. Cancer Res. 1995 Nov 15;55(22):5230-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder Cancer	Incident bladder cancer	1998-2000