Spanish Bladder Cancer Study

Study Name: Spanish Bladder Cancer Study (SBCS)

Principal Investigators:
NCI-DCEG: Debra Silverman, Nathaniel Rothman, Montse Garcia-Closas.
IMIM: Manolis Kogevinas, Núria Malats, Paco Real

Additional researchers:
Kenneth Cantor, NCI-DCEG
Joan Fortuny, IMIM
Montserrat Garcia-Closas, NCI-DCEG
Lee Moore, NCI-DCEG
Jonine Figueroa, NCI-DCEG
Joanne Colt, NCI-DCEG
Ludmila Prokunina, NCI-DCEG
Claudine Samanic, NCI-DCEG
Stephen Chanock, NCI-DCEG

Institution/s:
National Cancer Institute Division of Cancer Epidemiology and Genetics (NCI-DCEG), Rockville, MD
Institut Municipal d'Investigacio Medica (IMIM), Barcelona, Spain

Institution/s address:
NCI-DCEG
6120 Executive Boulevard
Bethesda, MD USA 20852-7234

IMIM
Centre for Research in Environmental Epidemiology (CREAL)
Respiratory and Environmental Health Research Unit
Dr Aiguader 80
08003 Barcelona, Spain

Key References:
Rothman N et al. Nature Gen. 2010 Nov;42(11):978-84
Cantor K et al. Environ Health Perspect. 2010 Jul 30. [Epub]
Silverman DT. Int J Cancer. 2008 Oct 1;123(7):1644-8.
Samanic C et al. Cancer Epidemiol Biomarkers Prev. 2006 Jul;15(7):1348-54
Lopez-Knowles E et al. Clin Cancer Res. 2006 Oct 15;12(20 Pt 1):6029-36
Garcia-Closas M et al. Lancet. 2005 Aug 20-26;366(9486):649-59

IRB Information
Name of PI for the IRB approved protocol: Debra Silverman

Study Design: Hospital-based Case-control

Matching factors: Gender, age, hospital/region

Country: Spain

Follow up of cases? Yes

Urinary Bladder ICD-0-3 morphology codes: Transitional cell carcinoma (81203); Papillary carcinoma (81303); Squamous cell carcinoma (80703); Adenocarcinoma (81403); Leiomyosarcoma (88903)

	Cases	Controls
Years of enrollment	1998-2001	1998-2001
Source population	18 hospitals in 5 regions of Spain	18 hospitals in 5 regions of Spain
Response rate (enrolled/eligible)	84%	88%
Total number enrolled	1219	1271
Subjects with DNA	1150	1149
Ethnic origin	99% Caucasian	99% Caucasian
Age: mean (range)	66 (21-80)	65(21-80)
Gender: % males	87%	87%

Questionnaire data	Cases	Controls
Demographics (age, sex, ethnicity, region, education etc..)	x	x
Active smoking	x	x
Passive smoking	x	x
Occupational exposures	x	x
Residential history	x	x
Water chlorination byproducts	x	x
Arsenic exposure	-	-
Other environmental exposures	x	x
Hair dye use	x	x
Drug use	x	x
Medical History	x	x
Family History	x	x
Quality of life	x	x
Diet/nutrition	x	x
Caffeine intake	x	x
Fluid intake	x	x
Urine pH measurements	x	x
Other information, please specify	-	-

Biological Samples	Cases	Controls
Blood DNA	x	x
Buccal DNA	x	x
Serum/plasma	x	x
Cryopreserved whole blood / lymphocytes	x	x
Red blood cells	x	x
Urine samples	-	-
Toenail clippings	x	x
Others, please specify	-	-
Paraffin tissue blocks	x
Frozen tissue	-

For Cases Only
Information at time of diagnosis	Cases
Histological confirmation	x
Number of tumors (available after follow up)	x
Tumor site	x
Tumor size	x
Tumor grade	x
Growth pattern	x
Treatment of primary tumor	-
Stage	x
Other information, please specify	-

Follow-up information	Cases
Treatment information	x
Tumor recurrence	x
Tumor progression	-
Survival	x
Histological confirmation	x
Number of tumors	x
Tumor site	x
Tumor size	x
Tumor grade	x
Growth pattern	x
Stage	x
Active smoking	x
Occupational exposures	x
Drug use	x
Medical History	x
Quality of life	x
Caffeine intake	x
Fluid intake	x
Other information , please specify (as above)	-