Contemporary Characteristics of Penile Cancer | NCT04996849

Studies
Contemporary Characteristics of Penile Cancer

NCT04996849

Sponsor

M.D. Anderson Cancer Center

Status

Terminated

Last Update Posted

Sep 24, 2025Actual

Enrollment

499Actual

Phase

Not provided

Conditions

Penile Carcinoma
Squamous Cell Carcinoma of the Penis

Interventions

Data Capture
Questionnaire Administration

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2021-07693	Registry Identifier	CTRP (Clinical Trial Reporting Program)
PCR04-0148	Other Identifier	M D Anderson Cancer Center

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

<75% participation

Expanded Access Info

Start Date

Apr 22, 2004Actual

Primary Completion Date

Sep 17, 2025Actual

Completion Date

Sep 17, 2025Actual

First Submitted Date

Jul 30, 2021

First Submission Date that Met QC Criteria

Jul 30, 2021

First Posted Date

Aug 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2025

Last Update Posted Date

Sep 24, 2025Actual

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

499Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational (data collection)		Patients undergo data collection every 6 months for up to 15 years.	Other: Data Capture Other: Questionnaire Administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data Capture	Other	Data collected	Observational (data collection)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients diagnosed with a primary penile malignancy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Curtis A Pettaway	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
M D Anderson Cancer Center		Houston	Texas	77030	United States

Label	URL
MD Anderson Cancer Center Website	View source

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Nov 22, 2022	Sep 18, 2025	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D010412	Penile Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided