ENPP1/cGAS (EG) and FAP Expression Profiles in Solid Tumors: An Immunohistochemical Study in a Vietnamese Cohort

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTam Anh Research Institute

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • IHC analysis for ENPP1, cGAS, and FAP expression

    Other intervention

    No experimental therapeutic intervention or drug treatment will be administered to the participants

Treatment groups

162 Participants
are divided into 1 treatment group
Group A: Patients with malignant solid tumors1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.