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| ID | Type | Description | Link |
|---|---|---|---|
| 1P20CA252732-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Cherokee Nation Health Services | UNKNOWN |
| Alaska Native Tribal Health Consortium | OTHER |
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We are performing a pilot and feasibility randomized controlled trial (RCT) of HCC screening by US + AFP every 6 months (n=100), the current standard-of-care, versus aMRI + AFP every 6 months (n=100) for 12 months (i.e. at time 0, 6 and 12 months) among AI/AN patients with cirrhosis or HBV.
We are performing a pilot and feasibility randomized controlled trial (RCT) of HCC screening by US + AFP every 6 months (n=100), the current standard-of-care, versus aMRI + AFP every 6 months (n=100) for 12 months (i.e. at time 0, 6 and 12 months) among AI/AN patients with cirrhosis or HBV.
We will compare the aMRI vs. the US arm with respect to the following outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound + AFP | Active Comparator | Screening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months |
|
| aMRI + AFP | Active Comparator | Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound or abbreviated MRI | Diagnostic Test | Abdominal ultrasound or abbreviated MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compliance with screening protocol | Compliance with conducting all three screening tests | 12 months |
| Feasibility of screening protocol | Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer R Harry | Contact | 206-616-0397 | jharry@medicine.washington.edu | |
| Stephanie Y Park | Contact | 206-744-7050 | sypark22@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| George Ioannou, MD, MS | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cherokee Nation Health Service | Recruiting | Tahlequah | Oklahoma | 74464 | United States |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008103 | Liver Cirrhosis |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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we are performing a pilot and feasibility randomized controlled trial (RCT) of HCC screening by US + AFP every 6 months (n=100), the current standard-of-care, versus aMRI + AFP every 6 months (n=100) for 12 months (i.e. at time 0, 6 and 12 months) among AI/AN patients with cirrhosis or HBV.
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |