Clinical trial NCT06068998: Molecular Characterization of Penile Cancers in Developing Countries
Official title: Molecular Characterization of Penile Cancers in Developing Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Penile Squamous Cell Carcinoma
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2023-10-05
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Biomarker Profiling of Penile Carcinoma by NGS
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Oncocentro Ceará
state: Ceará
city: São Luís
country: Brazil
facility: Hospital Universitário da Universidade Federal do Maranhão (UFMA)
state: Maranhão
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
Study officials:
affiliation: PUCRS School of Medicine
name: André Poisl Fay
role: PRINCIPAL_INVESTIGATOR
References: