Study of Outcomes After Surgery/Treatment to Treat Bladder Cancer

NCT01776138 | Completed DMC

• 2 other identifiers: LCCC120612-0577
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to create a registry of older patients undergoing surgical and/or medical treatment for bladder cancer. The registry will record side-effect and outcomes related to the treatment using different surveys and biological measures.

Conditions

Bladder Cancer

Keywords

Elderly; Chemotherapy; Cystectomy; Radical Cystectomy; University of North Carolina; Cancer; Bladder Cancer; Bladder

Outcome Measures

Primary Outcomes (1)

• To collect the number of changes in functional status, surgical complications and survival status collected in a prospective database of patients undergoing a radical cystectomy with or without chemotherapy

  To collect the number of changes in functional status, surgical complications, and survival in patients with urothelial carcinoma of the bladder following radical cystectomy with or without neoadjuvant chemotherapy in a prospective database (to be called the PORCH database- "Prospective Outcomes of Radical cystectomy with or without Chemotherapy").

  1 Year

Secondary Outcomes (2)

• To measure associations between baseline measures with post-surgery and 90 day outcome measures

  2 years

• To count changes over the course of treatment for components of the GA, the FACT-Bl, p16, and other clinical characteristics.

  2 years

Study Arms (1)

Bladder Cancer Patients

Patients diagnoses with bladder cancer who are eligible to undergo treatment.

Other: Collect Blood and Survey Instruments

Interventions

Collect Blood and Survey Instruments OTHER

Also known as: p16 Blood Collection, Geriatric Assessment, Fact-BL, Health Behavior Questionnaire

Bladder Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a known pathologic diagnosis of lower tract urothelial carcinoma who are eligible to undergo radical cystectomy with or without neoadjuvant chemotherapy for definitive diagnosis and treatment.

You may qualify if:

• Patients with a known pathologic diagnosis of lower tract urothelial carcinoma who are eligible to undergo radical cystectomy with or without neoadjuvant chemotherapy for definitive diagnosis and treatment.
• Signed, IRB approved written informed consent.
• Completion of baseline Geriatric Assessment

You may not qualify if:

• Inability to read and speak English
• Inability to comply with study for any other reason than language
• Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Neoplasms

Interventions

Surveys and Questionnaires; Geriatric Assessment

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Health Status; Demography; Population Characteristics; Epidemiologic Measurements

Study Officials

• Angela Smith, MD

  University of North Carolina Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: January 25, 2013
• Study Start: July 23, 2012
• Primary Completion: August 29, 2019
• Study Completion: September 2, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

US (1)