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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06068998
Other study ID # LACOG 2018
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
See also
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Active, not recruiting NCT02834013 - Nivolumab and Ipilimumab in Treating Patients With Rare Tumors Phase 2
Recruiting NCT03943602 - Cabozantinib in Patients With Advanced Penile Squamous Cell Carcinoma (PSCC) (CaboPen) Phase 2