Molecular Characterization of Penile Cancers in Developing Countries

NCT06068998 | Completed

• 1 other identifier: LACOG 2018
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Penile Squamous Cell Carcinoma

Outcome Measures

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.

  Through study completion, an average of 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Latin American Cooperative Oncology Group: lead
• Roche Pharma AG: collaborator

Study Sites (3)

Oncocentro Ceará

Fortaleza, Ceará, Brazil

Location

Hospital Universitário da Universidade Federal do Maranhão (UFMA)

São Luís, Maranhão, 65080-805, Brazil

Location

Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Location

Study Officials

• André Poisl Fay

  PUCRS School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 5, 2023
• Study Start: December 17, 2021
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

BR (3)