Epigenomic Biomarkers of HIV-Associated Hepatocellular Cancer in Nigeria

Overview

About this study

The main objective of this study is to identify minimally invasive, blood-based methylomic markers by comparing blood cfDNA methylation patterns among HIV-infected and uninfected HCC patients, and in HIV-infected but HCC-free patients. 
 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Aim 1 and 2

HCC cases (HIV infected, n=100) and controls (HIV uninfected, n=100): 

  1. >18yrs
  2. Confirmed to have HCC diagnosed by ultrasound and CT scan
  3. On stable antiretroviral therapy (ART) for at least 6 months

HIV-infected HCC negative controls (n=100):

  1. >18yrs
  2. On ART for at least 6 months.

Aim 3

  1. Known HIV statu 
  2. >18 years of age 
  3. TE score >9.3 Kpa 
  4. On ART for at least 6 months   
  5. Intending to stay in the Jos or Lagos area for at least 24 months 
  6. Not pregnant.

Exclusion Criteria:

Aim 1 and 2

HCC cases (HIV infected, n=100) and controls (HIV uninfected, n=100): 

  1. Other known primary or secondary malignancy; b) history of malignancy within the past 5 years.

HIV-infected HCC negative controls (n=100):

  1. Clinical and/or radiologic evidence of HCC, other liver diseases such as autoimmune hepatitis, cholestatic liver diseases, Wilson Disease, hemochromatosis; or other primary or secondary malignancy 
  2. >21 alcoholic drinks per week
  3. Adults unable to consent
  4. Individuals who are not yet adults (infants, children, teenagers)
  5. Pregnant women and Prisoners

Aim 3

  1. Have clinical and/or radiologic evidence of HCC, other liver diseases such as autoimmune hepatitis, cholestatic liver diseases, Wilson Disease, hemochromatosis; or other primary or secondary malignancy.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Lewis Roberts, M.B., Ch.B., Ph.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Hamdi Ali M.D.

Ali.Hamdi@mayo.edu

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions