Molecular Characterization of Penile Cancers in Developing Countries

October 3, 2023 updated by: Latin American Cooperative Oncology Group
This study explores penile squamous cell carcinoma (PSCC) in Brazil, a rare cancer associated with factors like poor hygiene and HPV infection, using next-generation sequencing to investigate its genomic profiles in 24 deceased patients with advanced PSCC.

Study Overview

Status

Completed

Conditions

Detailed Description

This study focuses on penile squamous cell carcinoma (PSCC), a rare cancer that is more prevalent in underdeveloped regions such as Africa, Asia, and South America, with Brazil having one of the highest incidence rates due to socioeconomic factors. PSCC is primarily associated with risk factors like poor local hygiene, smoking history, phimosis, and human papillomavirus (HPV) infection. The research aims to understand the genomic profiles of PSCC and their correlation with clinical characteristics, particularly in circumcised vs. non-circumcised populations in Brazil. The study will employ next-generation sequencing (NGS) on tumor specimens from 23 deceased patients with advanced PSCC who received treatment in Brazilian cancer sites.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Ceará
      • Fortaleza, Ceará, Brazil
        • Oncocentro Ceará
    • Maranhão
      • São Luís, Maranhão, Brazil, 65080-805
        • Hospital Universitário da Universidade Federal do Maranhão (UFMA)
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population comprises men aged 18 or older with a diagnosis of locally advanced or metastatic squamous-cell penile carcinoma, who have undergone at least one advanced disease treatment (surgery, radiotherapy, and/or chemotherapy), possess representative tumor blocks from formalin-fixed and paraffin-embedded (FFPE) archives, either from primary or metastatic sites, and are deceased at the time of data collection.

Description

Inclusion Criteria:

  • Men ≥ 18 years of age;
  • Diagnosis of locally advanced or metastatic squamous-cell penile carcinoma;
  • Have received at least one treatment for advanced disease (surgery, radiotherapy and/or chemotherapy);
  • Available representative tumor block of formalin-fixed and paraffin-embedded (FFPE) archive, from primary or metastasis;
  • Patients must be already deceased at time of data collection.

Exclusion Criteria:

  • Patients without medical record available (lost, empty or irretrievable clinical information).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker Profiling of Penile Carcinoma by NGS
Time Frame: Through study completion, an average of 2 years
The study employs state-of-the-art molecular analysis methods, including next-generation sequencing (NGS) using a targeted panel (FoundationONE CDx) that assesses 324 genes.
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Latin American Cooperative Oncology Group

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: André Poisl Fay, PUCRS School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2021

Primary Completion (Actual)

August 3, 2023

Study Completion (Actual)

August 3, 2023

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LACOG 2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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