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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04996849
Other study ID # PCR04-0148
Secondary ID NCI-2021-07693PC
Status Recruiting
Phase
First received
Last updated
Start date April 22, 2004
Est. completion date December 31, 2026

Study information

Verified date May 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study develops a prospective database of patients who are evaluated and treated for penile cancer. This will facilitate analyzing trends in cancer incidence, risk factors, treatment, complications, and tumor progression. It will also prospectively validate the importance of pathological prognostic factors previously reported and outcome related to contemporary treatment.


Description:

PRIMARY OBJECTIVE: I. To prospectively collect data on the presenting features, management and outcome of penile carcinoma at M.D. Anderson Cancer Center, and Harris Health System and Katy, Sugar Land, The Woodlands and Bay Area Regional Care Centers. OUTLINE: Patients undergo data collection every 6 months for up to 15 years.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria: - All diagnosed patients with a primary penile malignancy, including those with squamous carcinoma Exclusion Criteria: - No patient meeting the above criteria will be excluded

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Data Capture
Data collected
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prospectively collect data on the presenting features, management and outcome of penile carcinoma Descriptive statistics will be utilized where applicable to address questions relevant to the study aims. Up to 15 years
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