NCT00341861

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,925

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 1998

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

September 1, 1998

Completed
7.8 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
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2012

Completed
7.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

14.3 years

First QC Date

June 19, 2006

Last Update Submit

October 19, 2020

Conditions

Bladder Cancer

Keywords

Bladder CancerOccupational and Environmental RisksLifestyle FactorsEpidemiologyGenetic Susceptibility

Outcome Measures

Primary Outcomes (1)

  • Bladder Cancer

    Incident bladder cancer

    1998-2000

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a hospital-based case-control study.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Municipal d'Investigacio Medica

Barcelona, Spain

Location

Related Publications (3)

  • Agundez JA, Martinez C, Olivera M, Ledesma MC, Ladero JM, Benitez J. Molecular analysis of the arylamine N-acetyltransferase polymorphism in a Spanish population. Clin Pharmacol Ther. 1994 Aug;56(2):202-9. doi: 10.1038/clpt.1994.124.

    PMID: 8062497BACKGROUND

  • 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. doi: 10.1016/0006-2952(96)00165-7.

    PMID: 8687483BACKGROUND

  • 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.

    PMID: 7585581BACKGROUND

MeSH Terms

Conditions

Urinary Bladder NeoplasmsGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Debra Silverman, D.Sc.

    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

September 1, 1998

Primary Completion

December 4, 2012

Study Completion

October 14, 2020

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations

ES(1)