Contemporary Characteristics of Penile Cancer
Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04996849
Collaborator
National Cancer Institute (NCI) (NIH)
1,000
1
224.3
4.5
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVE:
- 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 Design
Study Type:
Observational
Anticipated Enrollment
:
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Contemporary Characteristics 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
Actual Study Start Date
:
Apr 22, 2004
Anticipated Primary Completion Date
:
Dec 31, 2021
Anticipated Study Completion Date
:
Dec 31, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational (data collection) Patients undergo data collection every 6 months for up to 15 years. |
Other: Data Capture
Data collected
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Curtis A Pettaway, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT04996849
Other Study ID Numbers:
- PCR04-0148
- NCI-2021-07693
- PCR04-0148
First Posted:
Aug 9, 2021
Last Update Posted:
Aug 9, 2021
Last Verified:
Jul 1, 2021
Additional relevant MeSH terms: