Molecular Characterization of Penile Cancers in Developing Countries

Penile Squamous Cell Carcinoma Clinical Trial

Official title:

Molecular Characterization of Penile Cancers in Developing Countries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06068998
• Other study ID #: LACOG 2018
• Status: Completed
• Start date: December 17, 2021
• Est. completion date: August 3, 2023

Study information

• Verified date: October 2023
• Source: Latin American Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 3, 2023
• Est. primary completion date: August 3, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Penile Neoplasms
• Penile Squamous Cell Carcinoma

Locations

Country	Name	City	State
Brazil	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

Sponsors (2)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group	Roche Pharma AG

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker Profiling of Penile Carcinoma by NGS	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