Molecular Characterization of Penile Cancers in Developing Countries

NCT ID: NCT06068998

Last Updated: 2023-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-17

Study Completion Date

2023-08-03

Brief Summary

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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

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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.

Conditions

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Penile Squamous Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Latin American Cooperative Oncology Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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André Poisl Fay

Role: PRINCIPAL_INVESTIGATOR

PUCRS School of Medicine

Locations

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Oncocentro Ceará

Fortaleza, Ceará, Brazil

Site Status

Hospital Universitário da Universidade Federal do Maranhão (UFMA)

São Luís, Maranhão, Brazil

Site Status

Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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LACOG 2018

Identifier Type: -

Identifier Source: org_study_id

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