Status:
ACTIVE_NOT_RECRUITING
Detect and Expunge Concealed Tumors of the Liver
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
108 Military Central Hospital, Hanoi, Viet Nam
Conditions:
Liver Cancer
Eligibility:
All Genders
18+ years
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 ...
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 sen...
Eligibility Criteria
Inclusion
- 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)
- No known AIDS related diseases
- No significant co-morbid conditions with life expectancy \<2 years
Exclusion
- 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
Key Trial Info
Start Date :
October 16 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06141564
Start Date
October 16 2023
End Date
December 1 2026
Last Update
November 18 2025
Active Locations (1)
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1
108 Military Central Hospital
Hanoi, Vietnam