About this trial
This Vietnam-based observational study examines ecto-nucleotide pyrophosphatase/phosphodiesterase 1/cyclic GMP-AMP synthase (ENPP1/cGAS) protein and stromal fibroblast activation protein (FAP) expression in multiple solid tumor samples using immunohistochemistry (IHC). The study involves no investigational treatments or participant-facing procedures. Tumor samples used in this study consist exclusively of archived formalin-fixed paraffin- embedded (FFPE) tumor samples that were collected as part of routine clinical diagnosis or treatment and for which all required procedures for standard clinical care have been completed. Only archived tumor samples obtained from routine clinical care will be included in this study. No additional biopsy, surgical resection, or specimen collection will be performed for research purposes, and no sample will be diverted prior to completion of clinical requirements. All included archived tumor samples will undergo ENPP1, cGAS, and FAP IHC analysis according to the procedures specified in the Laboratory Manual.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis: Patients with a histopathologically or cytologically confirmed diagnosis of malignant solid tumors, including but not limited to colorectal cancer (CRC), hepatocellular carcinoma (HCC), lung cancer, melanoma, pancreatic cancer,breast cancer, or other solid tumors relevant to the study objectives.
Age: Vietnamese patients aged ≥ 18 years at the time of tumor tissue collection.
Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens collected within 24 months prior to specimen eligibility verification and currently stored at the study site.
Tumor tissue specimens confirmed by a study pathologist to contain an adequate proportion of viable tumor cells (minimum of 1500 tumor cells per section) and sufficient material for analysis (at least one FFPE block or four unstained slides, 3-5 um in thickness).
Disqualifiers
Discordance between clinical diagnosis and tissue histopathology: The diagnosis documented in the medical record is inconsistent with the histopathological findings of the tissue specimen intended for study use.
Legal or policy restrictions: Patients or their legally authorized representatives have declined the use of tissue specimens for secondary research purposes, or the specimens are not permitted for research use under institutional policies or decisions of the LEC/IRB.
Trial population
Vietnamese adult patients (aged ≥18 years) diagnosed with histologically confirmed malignant solid tumors
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
IHC analysis for ENPP1, cGAS, and FAP expression
Other interventionNo experimental therapeutic intervention or drug treatment will be administered to the participants
Treatment groups
Trial outcomes
Primary outcomes
Prevalence of EG+ phenotype (ENPP1/cGAS co-expression) and stromal FAP expression
The primary objective analysis will estimate the prevalence of the EG+ phenotype (ENPP1/cGAS co-expression) and stromal FAP expression in the study cohort. Prevalence will be summarized overall and by major tumor type using descriptive statistics.
Sponsors and contacts
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