ACTIVE_NOT_RECRUITING

ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk

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Conditions

Hepatocellular CarcinomaHepatocellular CancerHepatitis BCirrhosisLiver CancerBlood Sample CollectionCT/MRIUltrasoundCombined Hepatocellular and CholangiocarcinomaHCC Surveillance

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.

Official Title

ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk

Quick Facts

Study Start:2021-07-26
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05064553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Be 18 years of age or older.
  2. 2. Understand the study procedures, be able to provide written informed consent to participate in the study, and have authorization for release of data, including personal health data and images, to the study Investigator, Sponsor, and regulatory authorities.
  3. 3. Present for surveillance imaging due to increased risk for HCC, including either:
  4. 1. Diagnosis of cirrhosis based on at least one of the following:
  5. * Histology from a liver biopsy.
  6. * Ultrasound, CT, or MRI showing a cirrhotic liver combined with portal hypertension (as evidenced by the presence of intra-abdominal varices, or recanalized umbilical vein, or ascites or splenomegaly or thrombocytopenia \[defined as Platelet count \< 150,000\]). The imaging results must have been obtained within 5 years of study enrollment.
  7. * Liver stiffness ≥4.71 kilopascal (kPa) by Magnetic Resonance (MR) elastography or ≥12.1 kPa by vibration controlled transient elastography.
  8. * Presence of varices on endoscopy or imaging and presence of a chronic liver disease. Endoscopy or imaging results must have been obtained within 5 years of study enrollment.
  9. 2. Non-cirrhotic subjects with chronic Hepatitis B Virus (HBV) infection (Hepatitis B surface antigen present for \>6 months)
  1. 1. Known cancer diagnosis (including active malignancy) within the past 5 years except for nonmelanoma skin cancer.
  2. 2. Chemotherapy and/or radiation therapy within 5 years prior to study enrollment.
  3. 3. Known Child-Pugh class C liver function at the time of enrollment, except for those on the waiting list for transplant.
  4. 4. Solid liver nodule \>1 cm by ultrasound or elevated Alpha-fetoprotein (AFP) (\>100 ng/mL) in 12 months preceding the qualifying surveillance imaging visit without subsequent documentation of HCC negative or LIRADS 1 (Liver Imaging Reporting and Data System) by diagnostic CT/MRI.
  5. 5. Females known to be pregnant at the time of enrollment.
  6. 6. Illness that the Investigator believes poses a significant risk of mortality during the study period, including but not limited to
  7. 1. Congestive heart failure with ejection fraction \<50%
  8. 2. Chronic lung disease requiring supplemental oxygen.
  9. 3. History of recent stroke.
  10. 7. Sustained virologic response (SVR) for Hepatitis C Virus (HCV) (undetectable HCV RNA 12 to 24 weeks after completion of antiviral therapy) for \>10 years prior to enrollment.
  11. 8. Not able to have IV contrast for CT or MRI due to
  12. 1. Allergy to IV contrast and unwilling or unable to receive IV contrast after pre-medication.
  13. 2. Estimated glomerular filtration rate \<35 mL/min and not on hemodialysis.

Contacts and Locations

Principal Investigator

Binu John
PRINCIPAL_INVESTIGATOR
Miami VA Healthcare System

Study Locations (Sites)

Arizona Health Research
Chandler, Arizona, 85225
United States
Arizona Digestive Health - Sun City
Sun City, Arizona, 85251
United States
Franco Felizarta, MD
Bakersfield, California, 93301
United States
Gastroenterology & Liver Institute
Escondido, California, 92025
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Providence Facey Medical Foundation
Mission Hills, California, 91345
United States
United Medical Doctors
Murrieta, California, 92563
United States
VA Palo Alto Healthcare System
Palo Alto, California, 94303
United States
Stanford University Medical Center
Palo Alto, California, 94304
United States
California Liver Research Institute
Pasadena, California, 91107
United States
Cadena Care Institute
Poway, California, 92064
United States
Inland Empire Clinical Trials
Rialto, California, 92377
United States
Research & Education, Inc
San Diego, California, 92105
United States
San Jose Gastroenterology
San Jose, California, 95128
United States
Rocky Mountain Gastroenterology
Littleton, Colorado, 80120
United States
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422
United States
University of Florida Hepatology Research at CTRB
Gainesville, Florida, 32610
United States
University of Florida - College of Medicine
Jacksonville, Florida, 32209
United States
ENCORE Borland Groover Clinical Research
Jacksonville, Florida, 32256
United States
Florida Research Institute
Lakewood, Florida, 34211
United States
Miami VA Healthcare System
Miami, Florida, 33125
United States
University of Miami
Miami, Florida, 33136
United States
San Marcus Research Clinic
Miami Lakes, Florida, 33014
United States
Tampa General Hospital
Tampa Bay, Florida, 33606
United States
Digestive Health Services
Downers Grove, Illinois, 60515
United States
Illinois Gastroenterology Group
Glenview, Illinois, 60026
United States
GI Alliance of Illinois - Gurnee
Gurnee, Illinois, 60031
United States
Gastroenterology and Internal Medicine Specialists
Lake Barrington, Illinois, 60010
United States
Avicenna Clinical Research
Oak Lawn, Illinois, 60463
United States
NAVREF - Indiana Institute for Medical Research (IIMC)
Indianapolis, Indiana, 46201
United States
Indiana University
Indianapolis, Indiana, 46202
United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Delta Research Partners
Monroe, Louisiana, 71201
United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105
United States
Patient First Clinical Trials
Nottingham, Maryland, 21236
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55902
United States
Southern Therapy and Advanced Research LLC (STAR)
Jackson, Mississippi, 39216
United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128
United States
St. Louis University
St Louis, Missouri, 63104
United States
Brooklyn VA Medical Center
Brooklyn, New York, 11209
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Manhattan Clinical Research, LLC
New York, New York, 10279
United States
Digestive Health Partners
Asheville, North Carolina, 28801
United States
Duke University Health Systems
Durham, North Carolina, 27710
United States
VA North East Ohio Health Care System
Cleveland, Ohio, 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Great Lakes Medical Research - Susquehanna Research Group
Camp Hill, Pennsylvania, 17011
United States
Corporal Michael J. Crescenz VA Medical Center
Philadelphia, Pennsylvania, 19104
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Xiaoli MA MD
Philadelphia, Pennsylvania, 19107
United States
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
Wilkes-Barre VA Medical Center
Wilkes-Barre, Pennsylvania, 18711
United States
University Gastroenterology West River
Providence, Rhode Island, 02904
United States
Ralph H Johnson VAMC
Charleston, South Carolina, 29401
United States
Gastro One
Germantown, Tennessee, 38138
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
Texas Gastro Clinic
El Paso, Texas, 79936
United States
Baylor - Saint Luke's Medical Center
Houston, Texas, 77030
United States
Lubbock Digestive Disease Associates
Lubbock, Texas, 79410
United States
Texas Digestive Disease Consultants - San Marcos
San Marcos, Texas, 78666
United States
Tranquil Clinical Research
Webster, Texas, 77598
United States
University of Vermont Medical Center
Burlington, Vermont, 05401
United States
UVA Gastroenterology
Charlottesville, Virginia, 22903
United States
Gastroenterology Associates, PC
Manassas, Virginia, 20110
United States
Digestive & Liver Disease Specialists
Norfolk, Virginia, 23502
United States
Bon Secours Liver Institute of Richmond
Richmond, Virginia, 23226
United States
Richmond VA Medical Center
Richmond, Virginia, 23249
United States
Washington Gastroenterology - Bellevue
Bellevue, Washington, 98056
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States
Velocity Clinical Research
Spokane, Washington, 99202
United States
Washington Gastroenterology - Tacoma
Tacoma, Washington, 98405
United States
UW Digestive Health Center
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Exact Sciences Corporation

  • Binu John, PRINCIPAL_INVESTIGATOR, Miami VA Healthcare System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-26
Study Completion Date2026-12

Study Record Updates

Study Start Date2021-07-26
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Blood Sample Collection
  • CT/MRI
  • Ultrasound
  • Combined Hepatocellular and Cholangiocarcinoma
  • HCC Surveillance

Additional Relevant MeSH Terms

  • Hepatocellular Carcinoma
  • Hepatocellular Cancer
  • Hepatitis B
  • Cirrhosis
  • Liver Cancer