Carcinoma, HepatocellularNCT02312817
RCT of Screening Strategies Among Patients at High Risk for Developing HCC in a Safety-net Health System
A study testing Mailed Outreach Invitation and Mailed Outreach Invitation and Patient Navigation in people with Carcinoma, Hepatocellular and Liver Neoplasms, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Hepatocellular carcinoma (HCC) is the 9th leading cause of cancer-related death in the US and one of the leading causes of death in patients with cirrhosis. Fewer than 1 in 5 high-risk patients undergo HCC screening, with lower rates in non-Caucasian and low socioeconomic status patients receiving care through… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular, Liver Neoplasms
- What is being tested?
- Mailed Outreach Invitation and Mailed Outreach Invitation and Patient Navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkland patients ≥ 21 years of age
- Diagnosis of cirrhosis or meets criteria for suspected cirrhosis
- ≥ 1 outpatient visit during 12 months prior to randomization
- Contact information on file
- English or Spanish speaking
Who cannot join
- HCC or suspicious mass on imaging
- Any malignancy except malignant neoplasm of skin
- Metastatic solid tumor
- Palliative care referral
- Liver transplant
- Child Pugh C
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkland Health & Hospital System
Dallas, Texas, 75235
About this study
Official title: RCT of Strategies to Improve Screening Rates Among a Cohort of Cirrhotic Patients at High Risk for Developing HCC in a Safety-net Health System
Hepatocellular carcinoma (HCC) is the 9th leading cause of cancer-related death in the US and one of the leading causes of death in patients with cirrhosis. Fewer than 1 in 5 high-risk patients undergo HCC screening, with lower rates in non-Caucasian and low socioeconomic status patients receiving care through safety-net health systems. Screening and follow-up failures lead to more advanced cancers, when curative therapies are not available and survival is significantly worse. Over 60% of HCC are diagnosed at advanced stages, due to poor recognition of high-risk patients, underuse of screening among these patients, and poor follow-up of abnormal screening tests. To address these barriers, the investigators propose to conduct a comparative effectiveness research randomized controlled trial of three screening strategies among a socioeconomically disadvantaged and racially diverse cohort of cirrhotic patients at high risk for developing HCC.
Overall, 1800 patients attending Parkland, the Dallas safety-net health system, will be randomized to:
Read more
- Group 1: Usual care, with visit-based HCC screening per discretion of individual providers
- Group 2: Mailed HCC screening invitation outreach to eligible patients (low resource intensity)
- Group 3: Mailed HCC screening invitation outreach to eligible patients combined with centralized patient navigation to promote screening completion and follow-up (high resource intensity)
Through three specific aims, this effectiveness research randomized controlled trial will:
- Aim 1: Engage stakeholders in design and implementation of HCC screening outreach interventions.
- Aim 2: Compare the clinical effectiveness and patient acceptability of the intervention strategies to increase completion of one-time and repeat HCC screening.
- Aim 3: Evaluate whether intervention effects are moderated by patient sex, race, ethnicity, English proficiency, and connectedness to primary care.
The screening intervention strategies combine EMR-enabled case identification, system-level screening outreach, and patient navigation to improve identification of previously unrecognized cirrhotic patients, promote HCC screening completion, and facilitate follow-up of abnormal screening tests. This study will engage stakeholders throughout the research process, evaluate the effectiveness and acceptability of HCC screening strategies, and determine which patient subgroups benefit the most.
- Conditions
- Carcinoma, Hepatocellular, Liver Neoplasms
- Being tested
- Mailed Outreach Invitation, Mailed Outreach Invitation and Patient Navigation
- Keywords
- Carcinoma, Hepatocellular, Liver Neoplasms, Liver Disease, Early Detection of Cancer, Comparative Effectiveness Research
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mailed Outreach InvitationOther
Individuals randomized to Group 2 will receive:
- Mailed outreach invitation to complete HCC screening ultrasound and alpha-fetoprotein (AFP) blood test.
- "Live" phone calls 2 to 4 weeks after the mailed invitation to facilitate HCC screening completion. Up to three attempts will be made. All communications will use standard English or Spanish scripts.
- Centralized process to promote guideline-appropriate follow up testing with CT or MRI or referral to GI Clinic.
Mailed Outreach Invitation and Patient NavigationOther
Individuals randomized to Group 3 will receive:
- Mailed outreach invitation to complete HCC screening ultrasound and alpha-fetoprotein (AFP) blood test.
- "Live" phone calls 2 to 4 weeks after the mailed invitation to facilitate HCC screening completion "and address patients' self-reported barriers to HCC screening (e.g., it does not apply to me). Up to three attempts will be made. All communications will use standard English or Spanish scripts.
- Centralized navigation to promote screening completion (i.e., appointment reminder phone calls from patient navigator) and guideline-appropriate follow up testing with CT or MRI or referral to GI Clinic.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Individuals randomized to Group 1 will receive usual medical care and will not be directly contacted at any point of the trial. Study data and outcomes will be abstracted from the EMR. |
| Group 2 | Experimental | Individuals randomized to Group 2 will receive mailed outreach invitation. Receives: Other: Mailed Outreach Invitation |
| Group 3 | Experimental | Individuals randomized to Group 3 will receive mailed outreach invitation and patient navigation. Receives: Other: Mailed Outreach Invitation and Patient Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-time Screening
Defined as the proportion of patients completing HCC screening within 6 months of randomization.
Measured: Outcomes will be adjudicated 6 months after randomization.
Repeat Screening (Every 6 Months)
Defined as the proportion of patients completing HCC screening every 6 months within 18 months of randomization.
Measured: Outcomes will be adjudicated 18 months after randomization.
Secondary outcomes (7)
Repeat Screening (Every 7 Months)
Defined as the proportion of patients completing HCC screening every 7 months within 21 months of randomization.
Measured: Outcomes will be adjudicated 21 months after randomization.
HCC and Early HCC
Defined as proportion of patients with HCC and the proportion of patients with early HCC.
Measured: Outcomes will be adjudicated 18 and 21 months after randomization.
Any HCC Screening
Defined as proportion of patients completing any HCC screening.
Measured: Outcomes will be adjudicated 18 and 21 months after randomization.
Predictors of HCC Screening Completion
Measured: Outcomes will be adjudicated 18 and 21 months after randomization.
Intervention Cost
Simple total program costs will be calculated for the intervention arms (Groups 2 and 3) and compared with a one-way ANOVA model.
Measured: Outcomes will be adjudicated 18 and 21 months after randomization.
Proportion of Time Covered
Defined as the proportion of time up-to date with HCC screening.
Measured: Outcomes will be adjudicated 18 and 21 months after randomization.
Suspicious Lesion
Defined as the proportion of patients with a suspicious lesion (as any solid-appearing mass ≥1 cm in diameter not characterized as benign).
Measured: Outcomes will be adjudicated 18 and 21 months after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Parkland Health and Hospital System, The University of Texas Health Science Center, Houston, Johns Hopkins Bloomberg School of Public Health
- Responsible party
- Principal investigator, Amit Singal, University of Texas Southwestern Medical Center
- Investigators
- Amit Singal, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312817
- Sponsor's protocol ID
- STU 102013-027
- Other IDs
- 1R24HS022418-01
- Status last verified
- Nov 2017
- First submitted
- 18 Jun 2014
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Singal AG, Tiro JA, Murphy CC, Marrero JA, McCallister K, Fullington H, Mejias C, Waljee AK, Pechero Bishop W, Santini NO, Halm EA. Mailed Outreach Invitations Significantly Improve HCC Surveillance Rates in Patients With Cirrhosis: A Randomized Clinical Trial. Hepatology. 2019 Jan;69(1):121-130. doi: 10.1002/hep.30129. Epub 2018 Dec 14.
PubMed 30070379Singal AG, Tiro JA, Marrero JA, McCallister K, Mejias C, Adamson B, Bishop WP, Santini NO, Halm EA. Mailed Outreach Program Increases Ultrasound Screening of Patients With Cirrhosis for Hepatocellular Carcinoma. Gastroenterology. 2017 Feb;152(3):608-615.e4. doi: 10.1053/j.gastro.2016.10.042. Epub 2016 Nov 5.
PubMed 27825963
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of Strategies to Improve Screening Rates Among a Cohort of Cirrhotic Patients at High Risk for Developing HCC in a Safety-net Health System
- ClinicalTrials.gov ID
- NCT02312817
- Acronym / sponsor ID
- STU 102013-027
- Conditions
- Carcinoma, Hepatocellular, Liver Neoplasms
- Keywords
- Carcinoma, Hepatocellular, Liver Neoplasms, Liver Disease, Early Detection of Cancer, Comparative Effectiveness Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Parkland Health and Hospital System, The University of Texas Health Science Center, Houston, Johns Hopkins Bloomberg School of Public Health
- Study start
- Dec 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatocellular carcinoma (HCC) is the 9th leading cause of cancer-related death in the US and one of the leading causes of death in patients with cirrhosis. Fewer than 1 in 5 high-risk patients undergo HCC screening, with lower rates in non-Caucasian and low socioeconomic status patients receiving care through safety-net health systems. Screening and follow-up failures lead to more advanced cancers, when curative therapies are not available and survival is significantly worse. Over 60% of HCC are diagnosed at advanced stages, due to poor recognition of high-risk patients, underuse of screening among these patients, and poor follow-up of abnormal screening tests. To address these barriers, the investigators propose to conduct a comparative effectiveness research randomized controlled trial of three screening strategies among a socioeconomically disadvantaged and racially diverse cohort of cirrhotic patients at high risk for developing HCC.
Overall, 1800 patients attending Parkland, the Dallas safety-net health system, will be randomized to:
- Group 1: Usual care, with visit-based HCC screening per discretion of individual providers
- Group 2: Mailed HCC screening invitation outreach to eligible patients (low resource intensity)
- Group 3: Mailed HCC screening invitation outreach to eligible patients combined with centralized patient navigation to promote screening completion and follow-up (high resource intensity)
Through three specific aims, this effectiveness research randomized controlled trial will:
- Aim 1: Engage stakeholders in design and implementation of HCC screening outreach interventions.
- Aim 2: Compare the clinical effectiveness and patient acceptability of the intervention strategies to increase completion of one-time and repeat HCC screening.
- Aim 3: Evaluate whether intervention effects are moderated by patient sex, race, ethnicity, English proficiency, and connectedness to primary care.
The screening intervention strategies combine EMR-enabled case identification, system-level screening outreach, and patient navigation to improve identification of previously unrecognized cirrhotic patients, promote HCC screening completion, and facilitate follow-up of abnormal screening tests. This study will engage stakeholders throughout the research process, evaluate the effectiveness and acceptability of HCC screening strategies, and determine which patient subgroups benefit the most.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Individuals randomized to Group 1 will receive usual medical care and will not be directly contacted at any point of the trial. Study data and outcomes will be abstracted from the EMR. |
| Group 2 | Experimental | Other: Mailed Outreach InvitationIndividuals randomized to Group 2 will receive mailed outreach invitation. |
| Group 3 | Experimental | Other: Mailed Outreach Invitation and Patient NavigationIndividuals randomized to Group 3 will receive mailed outreach invitation and patient navigation. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Parkland patients ≥ 21 years of age
- Diagnosis of cirrhosis or meets criteria for suspected cirrhosis
- ≥ 1 outpatient visit during 12 months prior to randomization
- Contact information on file
- English or Spanish speaking
Key exclusion criteria (6 listed)
- HCC or suspicious mass on imaging
- Any malignancy except malignant neoplasm of skin
- Metastatic solid tumor
- Palliative care referral
- Liver transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mailed Outreach InvitationIndividuals randomized to Group 2 will receive: 1. Mailed outreach invitation to complete HCC screening ultrasound and alpha-fetoprotein (AFP) blood test. 2. "Live" phone calls 2 to 4 weeks after the mailed invitation to facilitate HCC screening completion. Up to three attempts will be made. All communications will use standard English or Spanish scripts. 3. Centralized process to promote guideline-appropriate follow up testing with CT or MRI or referral to GI Clinic. | Other | Group 2 |
| Mailed Outreach Invitation and Patient NavigationIndividuals randomized to Group 3 will receive: 1. Mailed outreach invitation to complete HCC screening ultrasound and alpha-fetoprotein (AFP) blood test. 2. "Live" phone calls 2 to 4 weeks after the mailed invitation to facilitate HCC screening completion "and address patients' self-reported barriers to HCC screening (e.g., it does not apply to me). Up to three attempts will be made. All communications will use standard English or Spanish scripts. 3. Centralized navigation to promote screening completion (i.e., appointment reminder phone calls from patient navigator) and guideline-appropriate follow up testing with CT or MRI or referral to GI Clinic. | Other | Group 3 |
Primary outcome
One-time Screening
Time frame: Outcomes will be adjudicated 6 months after randomization.
Defined as the proportion of patients completing HCC screening within 6 months of randomization.
Repeat Screening (Every 6 Months)
Time frame: Outcomes will be adjudicated 18 months after randomization.
Defined as the proportion of patients completing HCC screening every 6 months within 18 months of randomization.
7 secondary outcomes
Repeat Screening (Every 7 Months)
Time frame: Outcomes will be adjudicated 21 months after randomization.
HCC and Early HCC
Time frame: Outcomes will be adjudicated 18 and 21 months after randomization.
Any HCC Screening
Time frame: Outcomes will be adjudicated 18 and 21 months after randomization.
Predictors of HCC Screening Completion
Time frame: Outcomes will be adjudicated 18 and 21 months after randomization.
Intervention Cost
Time frame: Outcomes will be adjudicated 18 and 21 months after randomization.
Proportion of Time Covered
Time frame: Outcomes will be adjudicated 18 and 21 months after randomization.
Suspicious Lesion
Time frame: Outcomes will be adjudicated 18 and 21 months after randomization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Derived from this study: PubMed 30070379Singal AG, Tiro JA, Murphy CC, Marrero JA, McCallister K, Fullington H, Mejias C, Waljee AK, Pechero Bishop W, Santini NO, Halm EA. Mailed Outreach Invitations Significantly Improve HCC Surveillance Rates in Patients With Cirrhosis: A Randomized Clinical Trial. Hepatology. 2019 Jan;69(1):121-130. doi: 10.1002/hep.30129. Epub 2018 Dec 14.
- Derived from this study: PubMed 27825963Singal AG, Tiro JA, Marrero JA, McCallister K, Mejias C, Adamson B, Bishop WP, Santini NO, Halm EA. Mailed Outreach Program Increases Ultrasound Screening of Patients With Cirrhosis for Hepatocellular Carcinoma. Gastroenterology. 2017 Feb;152(3):608-615.e4. doi: 10.1053/j.gastro.2016.10.042. Epub 2016 Nov 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Singal, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mailed Outreach Invitation and Mailed Outreach Invitation and Patient Navigation in people with Carcinoma, Hepatocellular and Liver Neoplasms, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-time Screening (time frame: Outcomes will be adjudicated 6 months after randomization.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02312817, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.