Contemporary Characteristics of Penile Cancer

Recruiting

• Conditions: Squamous Cell Carcinoma of the Penis; Penile Carcinoma
• Interventions: Other: Data Capture; Other: Questionnaire Administration

• Registration Number: NCT04996849
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2004-04-22
• Study First Submitted: 2021-07-30
• Study First Submitted QC: 2021-07-30
• Study First Posted: 2021-08-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 1000

Inclusion Criteria

• All diagnosed patients with a primary penile malignancy, including those with squamous carcinoma

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Exclusion Criteria

• No patient meeting the above criteria will be excluded

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (data collection)	Data Capture	Patients undergo data collection every 6 months for up to 15 years.
Observational (data collection)	Questionnaire Administration	Patients undergo data collection every 6 months for up to 15 years.

Primary Outcome Measures

Name	Time	Method
Prospectively collect data on the presenting features, management and outcome of penile carcinoma	Up to 15 years	Descriptive statistics will be utilized where applicable to address questions relevant to the study aims.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States