Trial Outcomes & Findings for HCC Screening Using DNA Methylation Changes in ctDNA (NCT NCT03483922)

Last Updated: 2024-07-05

Results Overview

We normalized median methylation values (range 0-100) for 'HCC-detect' (Hepatocellular Carcinoma Detection) and 'HCC-spec' (Hepatocellular Carcinoma Specificity). 'HCC-detect' is derived from CHFR, VASH2, CCNJ, and GRID2IP regions, aiming to broadly identify HCC. Theoretical range is -6.6438 to 8.6438, with observed -3.541 to 7.65; higher scores indicate increased HCC likelihood. 'HCC-spec', focusing on the F12 region, differentiates HCC from 31 other cancers and normal cells, with theoretical range -3.3219 to 6.64385 (observed -3.3219 to 6.6297). Higher scores signify greater HCC specificity. Both scores, modeled via logistic regression in Prism, predict HCC probability, linking higher scores with higher HCC likelihood or specificity

Recruitment status

COMPLETED

Target enrollment

403 participants

Primary outcome timeframe

6 months to 1 year

Results posted on

2024-07-05

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy This group included 49 healthy sex and age matched controls.	Chronic Hepatitis B This group included 51 Chronic hepatitis B patients	HCC Stage 0 This group included two patients with stage 0 (very early stage)	HCC Stage A This group included 32 patients with stage A (early stage)	HCC Stage B This group included 86 patients with stage B (intermediate stage) of HCC	HCC Stage C This group included 106 patients with stage C (advanced stage) of HCC	HCC Stage D This group included 76 patients with stage D (end stage) of HCC
Overall Study STARTED	49	51	2	32	86	106	76
Overall Study COMPLETED	49	51	2	32	86	106	76
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HCC Screening Using DNA Methylation Changes in ctDNA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy n=49 Participants Healthy controls	Chronic Hepatitis B n=51 Participants Chronic hepatitis B patients	HCC Stage 0 n=2 Participants HCC patients with Stage 0	HCC Stage A n=32 Participants HCC patients with Stage A	HCC Stage B n=86 Participants HCC patients with Stage B	HCC Stage C n=106 Participants HCC patients with Stage C	HCC Stage D n=76 Participants HCC patients with Stage D	Total n=402 Participants Total of all reporting groups
Age, Continuous	26.14 years n=5 Participants	28.71 years n=7 Participants	62 years n=5 Participants	49.15 years n=4 Participants	49.12 years n=21 Participants	49.34 years n=8 Participants	52.45 years n=8 Participants	44 years n=24 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	9 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	14 Participants n=21 Participants	21 Participants n=8 Participants	12 Participants n=8 Participants	68 Participants n=24 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	42 Participants n=7 Participants	2 Participants n=5 Participants	27 Participants n=4 Participants	72 Participants n=21 Participants	85 Participants n=8 Participants	64 Participants n=8 Participants	334 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	49 Participants n=5 Participants	51 Participants n=7 Participants	2 Participants n=5 Participants	32 Participants n=4 Participants	86 Participants n=21 Participants	106 Participants n=8 Participants	76 Participants n=8 Participants	402 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Region of Enrollment Bangladesh	49 Participants n=5 Participants	51 Participants n=7 Participants	2 Participants n=5 Participants	32 Participants n=4 Participants	86 Participants n=21 Participants	106 Participants n=8 Participants	76 Participants n=8 Participants	402 Participants n=24 Participants

PRIMARY outcome

Timeframe: 6 months to 1 year

Population: Out of the 402 participants, five did not meet the sequencing depth threshold (i.e., less than 100 reads per gene) for at least one gene, and they were excluded from subsequent analysis.

Outcome measures

Outcome measures
Measure	Healthy n=46 Participants Healthy controls	Chronic Hepatitis B n=49 Participants Patients with chronic hepatitis B	HCC Stage 0 n=2 Participants Patients with stage 0 HCC	HCC Stage A n=32 Participants Patients with stage A HCC	HCC Stage B n=86 Participants Patients with stage B HCC	HCC Stage C n=106 Participants Patients with stage C HCC	HCC Stage D n=76 Participants Patients with stage D HCC
Calculation of M Scores and HCC Probability Scores	1.113 units on a scale Standard Deviation 0.3267	1.159 units on a scale Standard Deviation 0.3508	1.797 units on a scale Standard Deviation 0.2483	1.707 units on a scale Standard Deviation 0.3615	1.839 units on a scale Standard Deviation 0.2268	1.818 units on a scale Standard Deviation 0.2525	1.891 units on a scale Standard Deviation 0.215

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Cheishvili

HKG Epitherapeutics

Phone: 5142601972

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place