Penile Squamous Cell CarcinomaNCT06068998
Molecular Characterization of Penile Cancers in Developing Countries
An observational study of Penile Squamous Cell Carcinoma, run by Latin American Cooperative Oncology Group at 3 sites in Brazil.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Penile Squamous Cell Carcinoma
- How many people
- 24 participants
- Where
- 3 sitesBrazil
- Study dates
- 17 Dec 2021to 3 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients without medical record available (lost, empty or irretrievable clinical information).
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Oncocentro Ceará
Fortaleza, Ceará
Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul
Hospital Universitário da Universidade Federal do Maranhão (UFMA)
São Luís, Maranhão, 65080-805
About this study
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.
- Conditions
- Penile Squamous Cell Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start17 Dec 2021
- Primary completion3 Aug 2023
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- André Poisl Fay, Principal investigator, PUCRS School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068998
- Sponsor's protocol ID
- LACOG 2018
- Status last verified
- Oct 2023
- First submitted
- 26 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characterization of Penile Cancers in Developing Countries
- ClinicalTrials.gov ID
- NCT06068998
- Acronym / sponsor ID
- LACOG 2018
- Conditions
- Penile Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients without medical record available (lost, empty or irretrievable clinical information).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biomarker Profiling of Penile Carcinoma by NGS
Time frame: Through study completion, an average of 2 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André Poisl Fay principal investigator
PUCRS School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Penile Squamous Cell Carcinoma, run by Latin American Cooperative Oncology Group at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker Profiling of Penile Carcinoma by NGS (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.