Penile squamous cell carcinoma
Conditions
Interventions
Observation group of penile Squamous cell carcinoma:None
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Diagnosis: Pathologically confirmed penile squamous cell carcinoma (including common subtypes: keratinizing/non-keratinizing, verrucous, basaloid, etc.); 2.Age: >18 years old; 3.Staging: Any clinical stage (c/pTNM acceptable), but surgical/biopsy timing and staging information must be available. 4.Treatment Status: Prospective cohort: Patients scheduled for surgical resection or diagnostic biopsy; treatment-naive cases (prior to systemic therapy or radiotherapy) will be prioritized for inclusion. Retrospective cohort: Treated patients may be included, provided treatment types and start/end dates are clearly documented for stratification/sensitivity analysis. (5) Sample Availability: Tissue samples suitable for TME/IME research must be accessible. 5.Sample Availability: Tissue samples suitable for TME/IME research must be accessible. 6.Complete Clinical Data: Key variables must include at minimum: age, tumor location/extent, surgical procedure, pTNM stage, grade, lymphovascular/perineural invasion, nodal status, recurrence/metastasis/survival outcomes, and treatment regimens. 7.Informed Consent/Ethics: Prospective studies require written informed consent. Retrospective studies must comply with ethical requirements for waived or supplemental consent.
Exclusion criteria
Exclusion criteria: 1.Non-conforming pathological type: Non-squamous cell carcinoma (e.g., melanoma, sarcoma, metastatic carcinoma, etc.) or only carcinoma in situ (CIS) without an invasive component, if the study is limited to invasive tumors. 2.Unclear or mixed tumor origin: Inability to confirm the primary site as the penis; presence of concurrent other primary malignant tumors where it is difficult to distinguish their contribution to outcomes (may be excluded or separately stratified based on study needs). 3.Severe comorbidities affecting immune status. 4.Active autoimmune disease requiring systemic immunosuppressive therapy. 5.Organ transplant recipients or long-term users of immunosuppressive drugs (e.g., =10 mg prednisone equivalent/day for >14 days), where this cannot be adequately adjusted for in the analysis. 6.Active severe infection (e.g., uncontrolled tuberculosis/bacterial sepsis, etc.). Active HIV/AIDS infection with profoundly low CD4 counts or other conditions causing extreme immune compromise, unless the study plans to include them in a predefined subgroup/use as a covariate (they can also be included with pre-specified subgroups/covariates). 7.Missing data: Lack of key clinical outcomes or treatment information, preventing completion of primary analysis. 8.Ethical or compliance reasons: Refusal or withdrawal of consent; inability to perform protocol-specified sampling/follow-up.HPV/p16 status, lichen sclerosus, etc., can be used as covariates/stratification variables and are not mandatory exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histological indicators: expression levels of proteins such as CD74, MIF, Ki-67, p53 in tumor and adjacent normal tissues.;Molecular indicators: mRNA expression levels of relevant genes (qPCR or RNA sequencing data);Clinicopathological parameters: age, tumor grade, stage, lymph node metastasis status; | — |
Countries
China
Contacts
Public ContactZhou Feng
The First Affiliated Hospital of Soochow University
Outcome results
None listed