HCC - Hepatocellular CarcinomaNCT07808164
ENPP1/cGAS (EG) and FAP Expression Profiles in Solid Tumors: An Immunohistochemical Study in a Vietnamese Cohort
An observational study of HCC - Hepatocellular Carcinoma and CRC (Colorectal Cancer), run by Tam Anh Research Institute at 2 sites in Vietnam.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma, CRC (Colorectal Cancer), Gastric Carcinoma
- What is being tested?
- IHC analysis for ENPP1, cGAS, and FAP expression
- How many people
- 162 participants
- Where
- 2 sitesVietnam
- Study dates
- 19 Mar 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Vietnamese adult patients (aged ≥18 years) diagnosed with histologically confirmed malignant solid tumors
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam2 sites, 2 recruiting
- Recruiting
Tam Anh General Hospital
Hanoi, Hanoi, 1000
Dung T Trinh, MD, PhD, (+84) 982 722 178, dungtt@tamanhhospital.vn
- Recruiting
Tam Anh TP. Ho Chi Minh Hospital
Ho Chi Minh City, Ho Chi Minh, 700000
Tung N Tran, MD, MsC, (+84) 795 583 356, tungtn1@tahospital.vn
About this study
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.
- Conditions
- HCC - Hepatocellular Carcinoma, CRC (Colorectal Cancer), Gastric Carcinoma, Breast Cancer, Lung Cancer, Endometrial Cancer
- Being tested
- IHC analysis for ENPP1, cGAS, and FAP expression
- Keywords
- cancer, IHC, ENPP1/cGAS (EG), FAP, Vietnam, Tam Anh TP. Ho Chi Minh Hospital, Tam Anh General Hospital, observation, Immunohistochemical Study
- Medical subject headings
- Carcinoma, Hepatocellular, Colorectal Neoplasms, Stomach Neoplasms, Breast Neoplasms, Lung Neoplasms, Endometrial Neoplasms, Melanoma, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IHC analysis for ENPP1, cGAS, and FAP expressionOther
No experimental therapeutic intervention or drug treatment will be administered to the participants
| Study group | Role | What they receive |
|---|---|---|
| Patients with malignant solid tumors | 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 whose tumor tissue samples are analyzed for ENPP1/cGAS (EG) and FAP Expression Receives: Other: IHC analysis for ENPP1, cGAS, and FAP expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start19 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular 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
- Cross-sectional
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tam Anh Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808164
- Sponsor's protocol ID
- IHC-001
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENPP1/cGAS (EG) and FAP Expression Profiles in Solid Tumors: An Immunohistochemical Study in a Vietnamese Cohort
- ClinicalTrials.gov ID
- NCT07808164
- Acronym / sponsor ID
- IHC-001
- Conditions
- HCC - Hepatocellular Carcinoma, CRC (Colorectal Cancer), Gastric Carcinoma, Breast Cancer, Lung Cancer, Endometrial Cancer
- Keywords
- cancer, IHC, ENPP1/cGAS (EG), FAP, Vietnam, Tam Anh TP. Ho Chi Minh Hospital, Tam Anh General Hospital, observation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Tam Anh Research InstituteUniversity, hospital or other
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Sep 2026 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with malignant solid tumors | – | Other: IHC analysis for ENPP1, cGAS, and FAP expressionPatients 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 whose tumor tissue samples are analyzed for ENPP1/cGAS (EG) and FAP Expression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Vietnamese adult patients (aged ≥18 years) diagnosed with histologically confirmed malignant solid tumors
Key inclusion criteria (8 listed)
- 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 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IHC analysis for ENPP1, cGAS, and FAP expressionNo experimental therapeutic intervention or drug treatment will be administered to the participants | Other | Patients with malignant solid tumors |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC - Hepatocellular Carcinoma and CRC (Colorectal Cancer), run by Tam Anh Research Institute at 2 sites in Vietnam.
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 8 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of EG+ phenotype (ENPP1/cGAS co-expression) and stromal FAP expression (time frame: At baseline). 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 26 Oct 2026.