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CompletedNCT06068998Updated Oct 5, 2023

Molecular Characterization of Penile Cancers in Developing Countries

An observational study in Penile Squamous Cell Carcinoma, sponsored by Latin American Cooperative Oncology Group. Completed at 3 sites in Brazil. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-05.

Sponsored by Latin American Cooperative Oncology Group · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
24
Ages
18 Years and older
Sex
Male
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Study 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.

Read the 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.

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Conditions studied

  • Penile Squamous Cell Carcinoma

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03

In context

Penile Neoplasms

80 studies on the registry are indexed under Penile Neoplasms; 25 are open to participants now.

This study's enrollment of 24 is below the median of 167 across 13 observational studies indexed under Penile Neoplasms.

Browse Penile Neoplasms studies →

Lead sponsor

Latin American Cooperative Oncology Group is the lead sponsor of 46 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study population comprises men aged 18 or older with a diagnosis of locally advanced or metastatic squamous-cell penile carcinoma, who have undergone at least one advanced disease treatment (surgery, radiotherapy, and/or chemotherapy), possess representative tumor blocks from formalin-fixed and paraffin-embedded (FFPE) archives, either from primary or metastatic sites, and are deceased at the time of data collection.

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

Exclusion Criteria:

  • Patients without medical record available (lost, empty or irretrievable clinical information).
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
24 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, an average of 2 years

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Study locations

3 sites
  • Oncocentro Ceará
    Fortaleza, Ceará, Brazil
  • Hospital Universitário da Universidade Federal do Maranhão (UFMA)
    São Luís, Maranhão 65080-805, Brazil
  • Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
    Porto Alegre, Rio Grande Do Sul, Brazil
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06068998
Lead sponsor
Latin American Cooperative Oncology Group
Collaborators
Roche Pharma AG
Responsible party
Sponsor
First posted
Oct 5, 2023
Start date
Dec 17, 2021
Primary completion
Aug 3, 2023
Completion
Aug 3, 2023
Last update
Oct 5, 2023

Study contacts

André Poisl Fay
principal investigator · PUCRS School of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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