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

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.

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Key information

Conditions

HCC - Hepatocellular Carcinoma Adenocarcinoma Breast Cancer Breast Diseases Breast Neoplasms CRC (Colorectal Cancer) Carcinoma Carcinoma, Hepatocellular Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Melanoma Melanoma (Skin Cancer) Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tam Anh General Hospital, Hanoi, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 and quality of biospecimens:

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).
Only archived residual tissue specimens remaining after completion of all routine clinical diagnostic and/or therapeutic purposes will be used for study purposes.
Availability of clinical data: Patient medical records must contain essential baseline information required for the study, including at minimum basic demographic data (age, sex) and histopathological diagnosis.
Ethical considerations: The study will be conducted using tissue specimens classified as archived samples at the time of eligibility assessment and is eligible for a waiver of informed consent in accordance with the requirements and approval of the Local Ethics Committee/Institutional Review Board (LEC/IRB).

Exclusion criteria

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.

Treatment and study plan

IHC analysis for ENPP1, cGAS, and FAP expression

Other

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

Primary outcomes

Prevalence of EG+ phenotype (ENPP1/cGAS co-expression) and stromal FAP expression

Time frame: At baseline

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 collaborators

Lead sponsor

Tam Anh Research Institute

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 8, 2026
Registry last updated: Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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