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NCT05196867Active, not recruiting

Liver Cancer Prevention Randomized Control Trial

A Randomized, Prospective Study of a Behaviorally-based Tailored Disease Management Intervention vs Control in Patients With Risk Factors for Liver Disease

Source: ClinicalTrials.gov · Last updated 12 Aug 2026

Brief summary (registry, in English)

To determine the effectiveness of a behaviorally-based tailored disease management intervention in patients with fibrosis or steatosis and risk factors for cirrhosis.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
49 (actual)
First submitted
29 Dec 2021
Start date
11 Feb 2022
Primary completion date
30 Aug 2028
Lead sponsor
M.D. Anderson Cancer Center
NCT number
NCT05196867

What you commit to

  • Study type: Interventional
  • Participants enrolled: 49
  • From 11 Feb 2022 to the primary completion date, 30 Aug 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Recent or planned surgery that would interfere with home-based exercise or a low-fat, high vegetable and fruit diet
  • Current or prior history of primary liver cancer or cancer that is metastatic to the liver

Other

  • Pregnant or planning to become pregnant in next 12 months (by self-report)
  • Medical contraindications to home-based exercise or low-fat, high-vegetable-and-fruit diet
  • AUDIT-10 score \>15
  • Family or household member already enrolled into study

Who the study is looking for

  • 1\. Evidence of steatosis (CAP score ≥ 290 by vibration controlled transient elastography) OR Evidence of liver fibrosis (FIB-4 index ≥ 1.6 or fibrosis grade ≥ F2 by vibration controlled transient elastography \[F2 score ≥ 8kPa\]) AND meets one of the following criteria: i. overweight or obese (BMI≥23 in Asians or BMI≥25 in other racial groups), OR ii. presence of type II diabetes mellitus, OR iii. lean/normal weight with presence of at least two metabolic risk abnormalities, OR:
  • Waist circumference ≥90/80 cm in Asians or ≥102/88 cm in other racial groups)
  • Blood pressure ≥130/85 mmHg or specific drug treatment
  • Plasma triglycerides ≥150 mg/dl or specific drug treatment
  • Plasma HDL-cholesterol \<40 mg/dl for men and \<50 mg/dl for women, or specific drug treatment
  • Prediabetes (fasting glucose levels 100-125 mg/dl , or HbA1c 5.7-6.4% ) iv. AUDIT-C ≥4 for men and ≥3 for women AND AUDIT-10 = 8-15
    • AND/OR 2. Evidence of liver fibrosis (FIB-4 index ≥ 1.6 or fibrosis grade ≥ F2 by vibration controlled transient elastography) and presence of one of the following:
  • chronic HBV (HBsAg+ or taking anti-HBV therapy), or
  • chronic HCV (1. detectable HCV RNA \> 4 months or a 2. history of HCV infection and taking anti-HCV therapy)
    • 3\. At least 18 years old 4. Speak and read English or Spanish 5. Access to smartphone with data plan or Wi-Fi access 6. Willing to receive up to 12 text messages per week

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.