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NCT02582918 · ClinicalTrials.gov registry record · NA
Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 2,871
- Enrollment target
NCT02582918: Completed NA study, sponsored by University of Texas Southwestern Medical Center.
NCT02582918 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 2,871 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (104% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02582918, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,871 participants
- Enrollment target
Study Summary
Project 5 of the Texas HCC Consortium (THCCC) is a comparative effectiveness pragmatic randomized control trial (RCT) of outreach strategies to increase hepatocellular cancer (HCC) surveillance process completion among a socioeconomically and racially diverse cohort of Texans with cirrhosis. Through this project the investigators will implement and evaluate system-level mailed outreach interventions to identity at-risk patients with cirrhosis, promote HCC surveillance, and ensure timely follow-up of tests at UT Southwestern (UTSW) Medical Center, Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs (VA) Medical Center. The study population will include adult patients with documented or unrecognized cirrhosis and at least one outpatient clinic visit in year prior to randomization. Patients will be identified using an EMR-enabled case identification algorithm. The investigators will randomize 3000 patients (1500 per arm) identified by this algorithm to: usual care, with opportunistic visit-based HCC surveillance (Group 1); or, mailed HCC surveillance outreach with patient education and patient navigation services (Group 2).
Primary Outcome
Ascertained through EMR. HCC surveillance process completion will be defined as: * normal ultrasound and AFP every 6 ± 1 months for two consecutive years, * abnormal ultrasound or AFP ≥20 ng/mL and follow-up diagnostic CT or MRI without HCC, then appropriate surveillance as indicated for total of 2 years, or * abnormal ultrasound or AFP, HCC detected on CT/MRI, and timely HCC treatment consultation. Effective surveillance requires repeat testing every 6 months in patients with normal tests to
Interventions
- BEHAVIORAL Outreach with patient education and patient navigation services
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,871 participants |
| Start Date | 2018-03-26 |
| Est. Completion | 2022-06-30 |
| Phase | NA |
What the finished NCT02582918 record still lists
NCT02582918 is an interventional study that assigns participants to a tested intervention. Its 2,871 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (104% higher).
The record links to 0 conditions, and to 1 intervention - of which Outreach with patient education and patient navigation services is the first listed.
NCT02582918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02582918 about?
NCT02582918 is a clinical study titled "Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5". Project 5 of the Texas HCC Consortium (THCCC) is a comparative effectiveness pragmatic randomized control trial (RCT) of outreach strategies to increase hepatocellular cancer (HCC) surveillance process completion among a socioeconomically and racially diverse cohort of Texans with cirrhosis. Through...
What is the current status of trial NCT02582918?
This trial is currently completed. It is a NA study. The enrollment target is 2,871 participants. The study started on 2018-03-26. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT02582918?
The interventions under investigation include: Outreach with patient education and patient navigation services (BEHAVIORAL).
Who is sponsoring clinical trial NCT02582918?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02582918's enrollment target sits among peer trials
2,871 43rd of 2000 higher than 1,958 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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