Liver CancerDTECT-LiverNCT06141564
Detect and Expunge Concealed Tumors of the Liver
An observational study of Liver Cancer, run by Johns Hopkins University at 1 site in Vietnam.
Trial summary
The investigators long-term goal is to identify molecular and immunological signatures that can be used as biomarkers to accurately predict early recurrence and inform immunotherapeutic strategies in patients with hepatocellular carcinoma (HCC) after hepatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- How many people
- 360 participants
- Where
- 1 siteVietnam
- Study dates
- 16 Oct 2023to 22 Dec 2026
- 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
- Adult, Older adult
Study population: Early stage HCCs who are eligible for hepatectomy Cirrhosis due to any etiologies, MELD <= 15 Chronic hepatitis due to any etiologies, without cirrhosis or HCC
Who may be able to join
- Provision of signed and dated informed consent form
- Collection of biosamples at baseline (sera, liver cancer and non liver cancer tissues, Peripheral blood mononuclear cells (PBMCs)) each of the 3-month interval follow ups (serum and PBMCs) for a total of 4 during the study follow up duration 1 year post-hepatectomy.
- Early-stage HCC eligible for hepatectomy for curative intention. Early HCC (Stage A) is limited to a single tumor <5 cm in diameter or three tumors that are each <3cm.
- Stated willingness to comply with all study procedures and availability for the duration of the study and up to 3 years post-study follow up
- Adults aged 18 or older
- Both genders and all ethnicities
Show all 17Show fewer
- Willingness to give written, informed consent to be enrolled into the study database
- Reside in Vietnam at the time of study and provides contact information (email and/or cell phone number for texting)
- No prior or current treatment of HCC
- No cancer history within 5 years
- No participation in other trial for HCC Treatment
- No significant hepatic decompensation
- No hepatorenal syndrome
- Alpha fetoprotein (AFP) test labs within 90 days irrespective of AFP titer
- Two phone numbers and personal identification numbers (CMND number)
- No known AIDS related diseases
- No significant co-morbid conditions with life expectancy <2 years
Who cannot join
- Individuals who cannot, do not want to, or refused to sign the informed consent form (ICF)
- Any serious or active medical or psychiatric illness, which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol
- Documentation was not adequate
- Known HIV positive
- Taking immunosuppressants
- Having any autoimmune diseases based on clinical and/or laboratory availabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular and Immunological Signatures in Recurrent Hepatocellular Carcinoma (HCC)
The investigators long-term goal is to identify molecular and immunological signatures that can be used as biomarkers to accurately predict early recurrence and inform immunotherapeutic strategies in patients with hepatocellular carcinoma (HCC) after hepatectomy. As an initial step toward this long-term investigation, represented by this proposal, the investigators aim to comprehensively and globally describe the patterns of autoantibody expressions, the possible role in disease outcomes, and the relationship between these autoantibodies to tumor-specific/tumor-associated antigens by histologic examination as well as to peripheral immune characteristics in HCC patients with or without recurrence after surgery.
Read the detailed description
The current methods for early detection and therapy for recurrent HCC are generally ineffective and mostly inaccessible to patients worldwide. Thus, there is an urgent unmet medical need to have a sensitive and accessible method for monitoring and guiding therapeutic strategy for HCC recurrence, which will improve the prognosis of patients.
The investigators current understanding of the mechanisms underpinning the onset and progression of HCC recurrence is incomplete. While tumor-related factors, including tumor size, number and differentiation, and underlying liver disease, are known risk factors for recurrence following curative therapies; evidence suggests that the recurrent mechanism is also governed by complex, poorly understood host immune responses. Tumor- and liver-infiltrating immune cells on the progression and recurrence of HCC have been documented. Tumor-infiltrating lymphocytes are believed to inhibit tumor growth, improving the prognosis of human malignancies. Inflammatory cytokines, including members of the interleukin (IL) and IL-11, contribute to hepatocyte proliferation and are also associated with cancer development after surgery. Unlike primary HCC, relapsed tumors have a higher immune evasion characteristic due to the accumulation of inhibitory cytokines and molecules. Moreover, the tumor microenvironment also plays a key role in the recurrence of HCC. Many immunosuppressive mechanisms, such as increased regulatory T cells and myeloid-derived suppressor cells with decreased cytotoxic T cells, are implicated in HCC recurrence.
Identifying panels of tumor antigens that elicit a humoral response may have utility in cancer screening, diagnosis, or prognosis. Such antigens may also have utility in designing immunotherapy against the disease. A proteomic-based approach for identifying tumor antigens that induce autoantibodies to tumor antigens can be detected using the Human Proteome (HuProt) arrays. The HuProt arrays, comprising 21,154 unique full-length proteins can be deployed to survey serum autoantibodies using primary or recurrent HCC samples. Likewise, profiling peripheral immune cell populations and cytokines will add another dimension to the landscape of HCC recurrence and host immune modulation.
In summary, identifying novel molecular and immunological markers in circulation and/or cancerous tissues is desirable to predict the risk of early primary and recurrent HCCs. This, coupled with several promising forms of immunotherapy for HCC that are currently available can help guide future therapies for HCCs.
- Conditions
- Liver Cancer
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early stage HCC | Not described | |
| Compensated cirrhosis | Not described | |
| Chronic hepatitis without cirrhosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCC recurrence diagnosed by dynamic contrast enhanced CT
Measured: Post-hepatectomy up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start16 Oct 2023
- Primary completion22 Dec 2026 (estimated)
- Study completion22 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- The 108 Military Central Hospital
- Responsible party
- Sponsor
- Investigators
- Doan Dao, MD, Principal investigator, Johns Hopkins School of MedicineBinh T Mai, MD, PhD, Principal investigator, The 108 Military Central HospitalChi V Dang, MD, PhD, Principal investigator, Johns Hopkins UniversityHeng Zhu, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141564
- Sponsor's protocol ID
- IRB00389479
- Acronym
- DTECT-Liver
- Status last verified
- Nov 2026
- First submitted
- 14 Nov 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Immunological Signatures in Recurrent Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT06141564
- Acronym / sponsor ID
- DTECT-Liver / IRB00389479
- Conditions
- Liver Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- The 108 Military Central Hospital
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 22 Dec 2026 (estimated)
- Study completion
- 22 Dec 2026 (estimated)
- First posted
- 21 Nov 2023 (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.
The investigators long-term goal is to identify molecular and immunological signatures that can be used as biomarkers to accurately predict early recurrence and inform immunotherapeutic strategies in patients with hepatocellular carcinoma (HCC) after hepatectomy. As an initial step toward this long-term investigation, represented by this proposal, the investigators aim to comprehensively and globally describe the patterns of autoantibody expressions, the possible role in disease outcomes, and the relationship between these autoantibodies to tumor-specific/tumor-associated antigens by histologic examination as well as to peripheral immune characteristics in HCC patients with or without recurrence after surgery.
Detailed description
The current methods for early detection and therapy for recurrent HCC are generally ineffective and mostly inaccessible to patients worldwide. Thus, there is an urgent unmet medical need to have a sensitive and accessible method for monitoring and guiding therapeutic strategy for HCC recurrence, which will improve the prognosis of patients.
The investigators current understanding of the mechanisms underpinning the onset and progression of HCC recurrence is incomplete. While tumor-related factors, including tumor size, number and differentiation, and underlying liver disease, are known risk factors for recurrence following curative therapies; evidence suggests that the recurrent mechanism is also governed by complex, poorly understood host immune responses. Tumor- and liver-infiltrating immune cells on the progression and recurrence of HCC have been documented. Tumor-infiltrating lymphocytes are believed to inhibit tumor growth, improving the prognosis of human malignancies. Inflammatory cytokines, including members of the interleukin (IL) and IL-11, contribute to hepatocyte proliferation and are also associated with cancer development after surgery. Unlike primary HCC, relapsed tumors have a higher immune evasion characteristic due to the accumulation of inhibitory cytokines and molecules. Moreover, the tumor microenvironment also plays a key role in the recurrence of HCC. Many immunosuppressive mechanisms, such as increased regulatory T cells and myeloid-derived suppressor cells with decreased cytotoxic T cells, are implicated in HCC recurrence.
Identifying panels of tumor antigens that elicit a humoral response may have utility in cancer screening, diagnosis, or prognosis. Such antigens may also have utility in designing immunotherapy against the disease. A proteomic-based approach for identifying tumor antigens that induce autoantibodies to tumor antigens can be detected using the Human Proteome (HuProt) arrays. The HuProt arrays, comprising 21,154 unique full-length proteins can be deployed to survey serum autoantibodies using primary or recurrent HCC samples. Likewise, profiling peripheral immune cell populations and cytokines will add another dimension to the landscape of HCC recurrence and host immune modulation.
In summary, identifying novel molecular and immunological markers in circulation and/or cancerous tissues is desirable to predict the risk of early primary and recurrent HCCs. This, coupled with several promising forms of immunotherapy for HCC that are currently available can help guide future therapies for HCCs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early stage HCC | – | – |
| Compensated cirrhosis | – | – |
| Chronic hepatitis without cirrhosis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Early stage HCCs who are eligible for hepatectomy Cirrhosis due to any etiologies, MELD <= 15 Chronic hepatitis due to any etiologies, without cirrhosis or HCC
Key inclusion criteria (17 listed)
- Provision of signed and dated informed consent form
- Collection of biosamples at baseline (sera, liver cancer and non liver cancer tissues, Peripheral blood mononuclear cells (PBMCs)) each of the 3-month interval follow ups (serum and PBMCs) for a total of 4 during the study follow up duration 1 year post-hepatectomy.
- Early-stage HCC eligible for hepatectomy for curative intention. Early HCC (Stage A) is limited to a single tumor <5 cm in diameter or three tumors that are each <3cm.
- Stated willingness to comply with all study procedures and availability for the duration of the study and up to 3 years post-study follow up
- Adults aged 18 or older
Key exclusion criteria (6 listed)
- Individuals who cannot, do not want to, or refused to sign the informed consent form (ICF)
- Any serious or active medical or psychiatric illness, which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol
- Documentation was not adequate
- Known HIV positive
- Taking immunosuppressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HCC recurrence diagnosed by dynamic contrast enhanced CT
Time frame: Post-hepatectomy up to 1 year
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 4 Nov 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. This study is not recruiting at the moment.
Doan Dao, MD principal investigator
Johns Hopkins School of Medicine
Binh T Mai, MD, PhD principal investigator
The 108 Military Central Hospital
Chi V Dang, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, run by Johns Hopkins University at 1 site 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 17 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCC recurrence diagnosed by dynamic contrast enhanced CT (time frame: Post-hepatectomy up to 1 year). 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 4 Nov 2026.