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OpenTrials
Completed

NCT Number: NCT06068998

Molecular Characterization of Penile Cancers in Developing Countries

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.

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Key information

Conditions

Penile Squamous Cell Carcinoma

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Oncocentro Ceará, Fortaleza, Ceará, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Latin American Cooperative Oncology Group

Other

Collaborators

  • Roche Pharma AG

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2023
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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