Detect and Expunge Concealed Tumors of the Liver

NCT06141564 | Active Not Recruiting DMC

• 1 other identifier: IRB00389479
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• HCC recurrence diagnosed by dynamic contrast enhanced CT

  Post-hepatectomy up to 1 year

Study Arms (3)

Early stage HCC

Compensated cirrhosis

Chronic hepatitis without cirrhosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• 108 Military Central Hospital, Hanoi, Viet Nam: collaborator

Study Sites (1)

108 Military Central Hospital

Hanoi, Vietnam

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, liver cancer tissues and non-cancerous tissues

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Doan Dao, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

• Binh T Mai, MD, PhD

  108 Military Central Hospital, Hanoi, Viet Nam

  PRINCIPAL INVESTIGATOR

• Chi V Dang, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Heng Zhu, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 21, 2023
• Study Start: October 16, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)