NCT04996849

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
499

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

April 22, 2004

Completed
17.3 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2025

Completed
Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

21.4 years

First QC Date

July 30, 2021

Last Update Submit

September 18, 2025

Conditions

Penile CarcinomaSquamous Cell Carcinoma of the Penis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Observational (data collection)

Patients undergo data collection every 6 months for up to 15 years.

Other: Data CaptureOther: Questionnaire Administration

Interventions

Data CaptureOTHER

Data collected

Observational (data collection)
Questionnaire AdministrationOTHER

Ancillary studies

Observational (data collection)

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with a primary penile malignancy

You may qualify if:

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

You may not qualify if:

  • No patient meeting the above criteria will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Penile Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesPenile DiseasesMale Urogenital Diseases

Study Officials

  • Curtis A Pettaway

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 30, 2021

First Posted

August 9, 2021

Study Start

April 22, 2004

Primary Completion

September 17, 2025

Study Completion

September 17, 2025

Last Updated

September 24, 2025

Record last verified: 2025-09

Locations

US(1)