Molecular Characterization of Penile Cancers in Developing Countries

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06068998

Enrollment

Registered

2023-10-05

Start date

2021-12-17

Completion date

2023-08-03

Last updated

2023-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Penile Squamous Cell Carcinoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Brazil

Outcome results