Carcinoma, HepatocellularNCT02582918
Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5
A study testing Outreach with patient education and patient navigation services in people with Carcinoma, Hepatocellular and Liver Neoplasms, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. 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?
- Outreach with patient education and patient navigation services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,871 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2018to 30 Jun 2022
- 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
- Adult patients (>21 years old)
- Documented cirrhosis
- Unrecognized cirrhosis
- An outpatient visit in year prior to randomization
- English or Spanish speaking
Who cannot join
- History of HCC
- History of liver transplantation
- Child Pugh C cirrhosis
- Significant comorbid conditions with life expectancy < 1 year, (e.g., extrahepatic malignancy)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Comparative Effectiveness Trial of Care Delivery Strategies for HCC Screening Process Completion
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).
Read the detailed description
Hepatocellular cancer (HCC) is the most common (≥ 95%) of liver cancers. HCC is also the fastest rising cause of cancer-related deaths in the U.S. HCC is particularly important for Texas residents. Texas has the second highest death rate from HCC in the nation. The 5-year HCC survival remains low (10-15%) and most patients get diagnosed at late stages. Texas residents notably Hispanics and African Americans are greatly affected with established HCC risk factors including hepatitis C virus, hepatitis B virus and alcoholic liver disease. Furthermore, emerging HCC risk factors, specifically the metabolic syndrome and non-alcoholic fatty liver disease (NAFLD), are exceptionally common in Texans.
The goal of the Texas Hepatocellular Carcinoma Consortium (THCCC) is to reduce the death and suffering related to liver cancer in Texas and the world through five research projects.
This protocol outlines Project 5 of the THCCC which is a comparative effectiveness randomized controlled trial of strategies to increase HCC surveillance. This is the first multi-center outreach intervention aimed at improving surveillance process completion among at-risk patients with cirrhosis.
This study is based at 3 health systems in Texas: UT Southwestern (UTSW) Medical Center, Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs (VA) Medical Center. Across these 3 sites, we 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. This study uses an EMR-enabled case-finding algorithm to identify patients with documented cirrhosis, using ICD-9 codes, and those with unrecognized cirrhosis, using laboratory data.
Over 3000 patients identified by this algorithm will be randomized to:
- Group 1: Usual care with opportunistic visit-based HCC surveillance.
- Group 2: Mailed HCC surveillance outreach with patient education and patient navigation services.
The Specific Aims are:
- Aim 1: Compare the clinical effectiveness of the intervention strategies to increase completion of the HCC surveillance process.
- Aim 2: Compare patient-reported satisfaction and acceptability of the HCC surveillance strategies.
- Aim 3: Evaluate whether intervention effects are moderated by patient sex, race/ethnicity, socioeconomic status, health care utilization, and documented vs. unrecognized cirrhosis.
- Conditions
- Carcinoma, Hepatocellular, Liver Neoplasms
- Being tested
- Outreach with patient education and patient navigation services
- Keywords
- Randomized Controlled Trial, Mass Screening
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outreach with patient education and patient navigation servicesBehavioural
- Outreach invitations include number to call for more information about scheduling an ultrasound and alpha fetoprotein (AFP) blood test.
- Patients receive up to three phone calls 2-4 weeks after invitations and a reminder call 5-7 business days before appointments.
- If results are normal, the patient is invited to repeat screening in 6 months.
- If suspicious mass on ultrasound or abnormal AFP level, the patient is referred for follow-up testing with triple-phase CT scan or MRI.
- If CT/MRI is unremarkable, the patient is referred back for routine screening.
- If HCC is confirmed, the patient and their primary care provider will be contacted with the results.
- All patients diagnosed with HCC will be seen in the multi-disciplinary HCC clinic.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Usual Care | No intervention | Usual care with opportunistic visit-based HCC surveillance. |
| Group 2: Patient Education and Patient Navigation Services | Experimental | Mailed HCC surveillance outreach with patient education and patient navigation services. Receives: Behavioral: Outreach with patient education and patient navigation services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of HCC surveillance process
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 maximize sensitivity while minimizing patient burden.
Patients with abnormal surveillance tests (i.e. liver mass on ultrasound or AFP ≥20 ng/mL) require 4-phase CT or MRI within 3 months, with a 3-month cut-off based on HCC tumor doubling time.
Patients with non-contrast imaging, two-phase CT, or imaging > 3 months after abnormal tests will be coded as failure.
Likewise, patients with HCC confirmed on CT/MRI will need HCC-directed treatment within 3 months.
Measured: 3 years post randomization
Patient satisfaction and acceptability
Assessed by 15-20 minute telephone semi-structured interviews.
Patients will be called >24 months post-randomization to ensure interviews do not interfere with likelihood of surveillance process completion.
The investigators will interview 30 completers and 30 non-completers from each group at each site (540 total).
The investigators will stratify sampling to include both patients with documented cirrhosis and unrecognized cirrhosis. Likert scale items will assess reactions:
- Participants were confused why they were referred for HCC screening
- Participants were not given enough information to make a decision
- Participants don't want to know if they have HCC
- Information about HCC was new and items assessing if invitations included more, right amount, or not enough information as the participants would like.
Interviews will also assess what HCC testing (if any) patients think they should have.
Measured: 3 years post randomization
Secondary outcomes (3)
Early HCC
HCC will be defined by AASLD criteria and staged by Barcelona Clinic Liver Cancer (BCLC) system.
Tumors >1 cm can be diagnosed if CT/MRI shows characteristic findings (arterial enhancement and delayed washout).
Biopsy may be needed if imaging is not diagnostic.
Early HCC will be defined as BCLC stage A tumors that are amenable to curative therapy.
HCC diagnoses and stage will be ascertained from EMR data and confirmed by site investigators.
Measured: 3 years post randomization
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
Defined as the proportion of patients completing HCC screening every 6 months within 12 months of randomization. Patients will be categorized as completed all screening (2 screening in 12 months), some screening (1 screening in 12 months), or no screening (0 screening in 12 months).
Measured: Outcomes will be adjudicated 12 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 posted21 Oct 2015 (estimated)
- Study start26 Mar 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2,871 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Parkland Health and Hospital System, Michael E. DeBakey VA Medical Center
- Responsible party
- Principal investigator, Amit Singal, University of Texas Southwestern Medical Center
- Investigators
- Amit G Singal, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582918
- Sponsor's protocol ID
- 062015-054
- Status last verified
- Sep 2022
- First submitted
- 13 Oct 2015
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patel A, Gavrila E, Yekkaluri S, Hoshida Y, Hernaez R, Singal AG. Net benefit of surveillance varies by hepatocellular carcinoma risk in patients with cirrhosis. JHEP Rep. 2026 Mar 25;8(8):101831. doi: 10.1016/j.jhepr.2026.101831. Online ahead of print.
PubMed 41895663Singal AG, Daher D, Narasimman M, Yekkaluri S, Liu Y, Cerda V, Banala C, Khan A, Lee M, Seif El Dahan K, Murphy CC, Kramer JR, Hernaez R. Benefits and harms of hepatocellular carcinoma screening outreach in patients with cirrhosis: a multicenter randomized clinical trial. J Natl Cancer Inst. 2025 Feb 1;117(2):262-269. doi: 10.1093/jnci/djae228.
PubMed 39288308Singal AG, Narasimman M, Daher D, Yekkaluri S, Liu Y, Lee M, Cerda V, Khan A, Seif El Dahan K, Kramer J, Gopal P, Murphy C, Hernaez R. Effectiveness of mailed outreach and patient navigation to promote HCC screening process completion: a multicentre pragmatic randomised clinical trial. Gut. 2024 Nov 11;73(12):2037-2044. doi: 10.1136/gutjnl-2024-332508.
PubMed 38839269Singal AG, Reddy S, Radadiya Aka Patel H, Villarreal D, Khan A, Liu Y, Cerda V, Rich NE, Murphy CC, Tiro JA, Kramer JR, Hernaez R. Multicenter Randomized Clinical Trial of a Mailed Outreach Strategy for Hepatocellular Carcinoma Surveillance. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2818-2825.e1. doi: 10.1016/j.cgh.2021.12.014. Epub 2021 Dec 10.
PubMed 34902568
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Trial of Care Delivery Strategies for HCC Screening Process Completion
- ClinicalTrials.gov ID
- NCT02582918
- Acronym / sponsor ID
- 062015-054
- Conditions
- Carcinoma, Hepatocellular, Liver Neoplasms
- Keywords
- Randomized Controlled Trial, Mass Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,871 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Parkland Health and Hospital System, Michael E. DeBakey VA Medical Center
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 21 Oct 2015 (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.
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).
Detailed description
Hepatocellular cancer (HCC) is the most common (≥ 95%) of liver cancers. HCC is also the fastest rising cause of cancer-related deaths in the U.S. HCC is particularly important for Texas residents. Texas has the second highest death rate from HCC in the nation. The 5-year HCC survival remains low (10-15%) and most patients get diagnosed at late stages. Texas residents notably Hispanics and African Americans are greatly affected with established HCC risk factors including hepatitis C virus, hepatitis B virus and alcoholic liver disease. Furthermore, emerging HCC risk factors, specifically the metabolic syndrome and non-alcoholic fatty liver disease (NAFLD), are exceptionally common in Texans.
The goal of the Texas Hepatocellular Carcinoma Consortium (THCCC) is to reduce the death and suffering related to liver cancer in Texas and the world through five research projects.
This protocol outlines Project 5 of the THCCC which is a comparative effectiveness randomized controlled trial of strategies to increase HCC surveillance. This is the first multi-center outreach intervention aimed at improving surveillance process completion among at-risk patients with cirrhosis.
This study is based at 3 health systems in Texas: UT Southwestern (UTSW) Medical Center, Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs (VA) Medical Center. Across these 3 sites, we 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. This study uses an EMR-enabled case-finding algorithm to identify patients with documented cirrhosis, using ICD-9 codes, and those with unrecognized cirrhosis, using laboratory data.
Over 3000 patients identified by this algorithm will be randomized to:
- Group 1: Usual care with opportunistic visit-based HCC surveillance.
- Group 2: Mailed HCC surveillance outreach with patient education and patient navigation services.
The Specific Aims are:
- Aim 1: Compare the clinical effectiveness of the intervention strategies to increase completion of the HCC surveillance process.
- Aim 2: Compare patient-reported satisfaction and acceptability of the HCC surveillance strategies.
- Aim 3: Evaluate whether intervention effects are moderated by patient sex, race/ethnicity, socioeconomic status, health care utilization, and documented vs. unrecognized cirrhosis.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Usual Care | No intervention | –Usual care with opportunistic visit-based HCC surveillance. |
| Group 2: Patient Education and Patient Navigation Services | Experimental | Behavioral: Outreach with patient education and patient navigation servicesMailed HCC surveillance outreach with patient education and patient navigation services. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (>21 years old)
- Documented cirrhosis
- Unrecognized cirrhosis
- An outpatient visit in year prior to randomization
- English or Spanish speaking
Key exclusion criteria (4 listed)
- History of HCC
- History of liver transplantation
- Child Pugh C cirrhosis
- Significant comorbid conditions with life expectancy < 1 year, (e.g., extrahepatic malignancy)
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 |
|---|---|---|
| Outreach with patient education and patient navigation services* Outreach invitations include number to call for more information about scheduling an ultrasound and alpha fetoprotein (AFP) blood test. * Patients receive up to three phone calls 2-4 weeks after invitations and a reminder call 5-7 business days before appointments. * If results are normal, the patient is invited to repeat screening in 6 months. * If suspicious mass on ultrasound or abnormal AFP level, the patient is referred for follow-up testing with triple-phase CT scan or MRI. * If CT/MRI is unremarkable, the patient is referred back for routine screening. * If HCC is confirmed, the patient and their primary care provider will be contacted with the results. * All patients diagnosed with HCC will be seen in the multi-disciplinary HCC clinic. | Behavioural | Group 2: Patient Education and Patient Navigation Services |
Primary outcome
Completion of HCC surveillance process
Time frame: 3 years post randomization
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 maximize sensitivity while minimizing patient burden. Patients with abnormal surveillance tests (i.e. liver mass on ultrasound or AFP ≥20 ng/mL) require 4-phase CT or MRI within 3 months, with a 3-month cut-off based on HCC tumor doubling time. Patients with non-contrast imaging, two-phase CT, or imaging > 3 months after abnormal tests will be coded as failure. Likewise, patients with HCC confirmed on CT/MRI will need HCC-directed treatment within 3 months.
Patient satisfaction and acceptability
Time frame: 3 years post randomization
Assessed by 15-20 minute telephone semi-structured interviews. Patients will be called >24 months post-randomization to ensure interviews do not interfere with likelihood of surveillance process completion. The investigators will interview 30 completers and 30 non-completers from each group at each site (540 total). The investigators will stratify sampling to include both patients with documented cirrhosis and unrecognized cirrhosis. Likert scale items will assess reactions: * Participants were confused why they were referred for HCC screening * Participants were not given enough information to make a decision * Participants don't want to know if they have HCC * Information about HCC was new and items assessing if invitations included more, right amount, or not enough information as the participants would like. Interviews will also assess what HCC testing (if any) patients think they should have.
3 secondary outcomes
Early HCC
Time frame: 3 years post randomization
One-time Screening
Time frame: Outcomes will be adjudicated 6 months after randomization.
Repeat Screening
Time frame: Outcomes will be adjudicated 12 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 28 Sep 2022.
- Derived from this study: PubMed 41895663Patel A, Gavrila E, Yekkaluri S, Hoshida Y, Hernaez R, Singal AG. Net benefit of surveillance varies by hepatocellular carcinoma risk in patients with cirrhosis. JHEP Rep. 2026 Mar 25;8(8):101831. doi: 10.1016/j.jhepr.2026.101831. Online ahead of print.
- Derived from this study: PubMed 39288308Singal AG, Daher D, Narasimman M, Yekkaluri S, Liu Y, Cerda V, Banala C, Khan A, Lee M, Seif El Dahan K, Murphy CC, Kramer JR, Hernaez R. Benefits and harms of hepatocellular carcinoma screening outreach in patients with cirrhosis: a multicenter randomized clinical trial. J Natl Cancer Inst. 2025 Feb 1;117(2):262-269. doi: 10.1093/jnci/djae228.
- Derived from this study: PubMed 38839269Singal AG, Narasimman M, Daher D, Yekkaluri S, Liu Y, Lee M, Cerda V, Khan A, Seif El Dahan K, Kramer J, Gopal P, Murphy C, Hernaez R. Effectiveness of mailed outreach and patient navigation to promote HCC screening process completion: a multicentre pragmatic randomised clinical trial. Gut. 2024 Nov 11;73(12):2037-2044. doi: 10.1136/gutjnl-2024-332508.
- Derived from this study: PubMed 34902568Singal AG, Reddy S, Radadiya Aka Patel H, Villarreal D, Khan A, Liu Y, Cerda V, Rich NE, Murphy CC, Tiro JA, Kramer JR, Hernaez R. Multicenter Randomized Clinical Trial of a Mailed Outreach Strategy for Hepatocellular Carcinoma Surveillance. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2818-2825.e1. doi: 10.1016/j.cgh.2021.12.014. Epub 2021 Dec 10.
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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 G 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 Outreach with patient education and patient navigation services 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 4 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 28 Sep 2022. 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?
Completion of HCC surveillance process (time frame: 3 years post 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 NCT02582918, which also lists 4 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 28 Sep 2022.