Penile Squamous Cell Carcinoma Clinical Trial
Official title:
Molecular Characterization of Penile Cancers in Developing Countries
NCT number | NCT06068998 |
Other study ID # | LACOG 2018 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 17, 2021 |
Est. completion date | August 3, 2023 |
Verified date | October 2023 |
Source | Latin American Cooperative Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | August 3, 2023 |
Est. primary completion date | August 3, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Brazil | Oncocentro Ceará | Fortaleza | Ceará |
Brazil | Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande Do Sul |
Brazil | Hospital Universitário da Universidade Federal do Maranhão (UFMA) | São Luís | Maranhão |
Lead Sponsor | Collaborator |
---|---|
Latin American Cooperative Oncology Group | Roche Pharma AG |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Through study completion, an average of 2 years |
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