Molecular Characterization of Penile Cancers in Developing Countries

Completed

• Conditions: Penile Squamous Cell Carcinoma

• Registration Number: NCT06068998
• Lead Sponsor: Latin American Cooperative Oncology Group

Brief Summary

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.

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 Timeline

• Study Start: 2021-12-17
• Primary Completion: 2023-08-03
• Study Completion: 2023-08-03
• Study First Submitted: 2023-09-26
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-03
• Last Update Submitted: 2023-10-03
• Study First Posted: 2023-10-05
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biomarker Profiling of Penile Carcinoma by NGS	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.

Trial Locations

Locations (3)

Oncocentro Ceará; 🇧🇷 Fortaleza, Ceará, Brazil

Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital Universitário da Universidade Federal do Maranhão (UFMA); 🇧🇷 São Luís, Maranhão, Brazil