Lynch SyndromePredict_LS_VNNCT06863038
Predictive Value of PREMM5, MMRpredict, and Universal Tumor Screening for Lynch Syndrome in Vietnam
An observational study of Lynch Syndrome and Colorectal Cancer (CRC), run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
This study evaluates the predictive value of PREMM5, MMRpredict models, and Universal Tumor Screening in detecting Lynch Syndrome in colorectal cancer (CRC) patients in Vietnam. Vietnamese CRC patients (18-70 years) undergoing colonoscopy will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lynch Syndrome, Colorectal Cancer (CRC)
- How many people
- 572 participants
- Where
- 1 siteVietnam
- Study dates
- 17 Mar 2025to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include Vietnamese patients aged 18-70 years who undergo colonoscopy at the University Medical Center Ho Chi Minh City and Nguyen Tri Phuong Hospital with suspected colorectal tumors. Eligible participants will be those diagnosed with colorectal adenocarcinoma through biopsy.
Who may be able to join
- Aged 18 to 70 years
- Provide informed consent to participate in the study
- Undergo colonoscopy with endoscopic findings suspicious for CRC
- Have biopsy-confirmed adenocarcinoma through colonoscopic biopsy
Who cannot join
- Active gastrointestinal bleeding
- Currently using anticoagulants or antiplatelet agents
- History of coagulation disorders or difficulty controlling bleeding
- Incomplete colonoscopy to the cecum (excluding cases of tumor-induced obstruction)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, 700000
Doan TN Nguyen, MD, +840918206883, nhadoannguyen@ump.edu.vn
Doan TN Nguyen, MD
About this study
Official title: Predictive Value of the PREMM5, MMRpredict Models, and the Universal Tumor Screening Strategy for Lynch Syndrome in Vietnam
This study evaluates the predictive value of PREMM5, MMRpredict models, and Universal Tumor Screening in detecting Lynch Syndrome in colorectal cancer (CRC) patients in Vietnam.
Vietnamese CRC patients (18-70 years) undergoing colonoscopy will be enrolled. Participants will complete a medical history questionnaire and provide blood samples for genetic testing. Tumor biopsy specimens will undergo Immunohistochemistry staining, BRAF V600E mutation, and MLH1 methylation analysis in case of loss of MLH1/PMS2 expression. Next-Generation Sequencing will detect germline MMR mutations, and biallelic somatic mutations will be analyzed if no germline mutations are found.
Read the detailed description
- Background and Rationale Colorectal cancer (CRC) is one of the most prevalent malignancies worldwide and the second leading cause of cancer-related deaths. Approximately 5-6% of CRC cases are associated with hereditary cancer syndromes, with Lynch Syndrome (LS) being the most common. LS results from germline mutations in the Mismatch Repair (MMR) genes (MLH1, MSH2, MSH6, PMS2, and EPCAM), which lead to microsatellite instability (MSI) and an increased risk of CRC, endometrial, and other extracolonic malignancies. Despite its significance, LS remains underdiagnosed, particularly in Asian populations, due to the limitations of traditional screening criteria, such as Amsterdam II and the Revised Bethesda Guidelines, which have low sensitivity in identifying LS patients. In response, universal tumor-based screening using MSI testing and immunohistochemistry (IHC) for MMR protein loss has been proposed as an effective alternative. Additionally, prediction models such as PREMM5 and MMRpredict have been developed to estimate LS risk based on clinical and family history. However, these models and tumor screening strategies have not been validated in the Vietnamese population. This study aims to evaluate and compare the predictive performance of different screening approaches for LS in Vietnamese CRC patients, thereby optimizing genetic testing selection and early diagnosis.
- Study Design and Setting This is a cross-sectional study conducted at two major hospitals in Vietnam:
- University Medical Center at Ho Chi Minh City - GI Endoscopy Department
- Nguyen Tri Phuong Hospital - GI Endoscopy \& Gastrointestinal Surgery Departments The study will enroll CRC patients aged 18-70 years who undergo colonoscopy with suspected tumors and are subsequently diagnosed with colorectal adenocarcinoma.
- Objectives Primary Objective:
- To assess the predictive value of PREMM5, MMRpredict, and Universal Tumor Screening Strategy in detecting Lynch Syndrome in CRC patients. Secondary Objectives:
- To determine the prevalence of Lynch Syndrome based on germline MMR gene mutation testing.
- To describe the clinical characteristics of Lynch Syndrome-Associated CRCs.
- To describe the the endoscopic and histopathological features of Lynch Syndrome-Associated CRCs
- To compare the diagnostic accuracy (AUC-ROC, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)) of different screening models and criteria, including Amsterdam II, Revised Bethesda Guidelines, PREMM5, MMRpredict, and Universal Tumor Screening.
- Study Procedures Patient Enrollment \& Sample Collection Eligible patients will:
- Provide informed consent before participation.
- Complete a medical history questionnaire assessing:
- Family history of CRC and LS-related cancers.
- Personal history of CRC, endometrial, and other extracolonic malignancies.
- Clinical symptoms and lifestyle risk factors.
- Provide a 2 mL blood sample for germline genetic testing.
- Laboratory Analysis
- Histopathological Evaluation: Tumor biopsy samples will be fixed in formalin, sectioned, and stained for Hematoxylin-Eosin (H\&E) evaluation.
- MMR Protein Expression: IHC will assess the loss of MLH1, MSH2, MSH6, and PMS2 expression.
- BRAF V600E Mutation \& MLH1 Methylation: Tumors with MLH1/PMS2 loss will undergo further testing to determine sporadic vs. hereditary LS cases.
- Germline MMR Mutation Testing: All the blood samples will undergo Next-Generation Sequencing (NGS) to detect pathogenic germline MMR mutations.
- Biallelic Somatic Mutation Analysis: If no germline mutations are identified in case of MLH1/PMS2 expression loss and no BRAF V600E mutation and no MLH1 methylation, tumor tissue sequencing will determine biallelic somatic inactivation.
- Statistical Considerations Sample Size Calculation The sample size is calculated based on the estimated prevalence of LS at 2.9%, requiring at least 572 participants (including a 10% dropout rate) to achieve statistical power.
- Statistical Analysis
- Quantitative variables (e.g., age, tumor size) will be expressed as mean ± standard deviation or median with interquartile range.
- Categorical variables (e.g., IHC results, BRAF V600E mutation) will be reported as percentages.
- Diagnostic performance will be evaluated using Receiver Operating Characteristic (ROC) curves, sensitivity, specificity, PPV, and NPV.
- Comparison of screening models (Amsterdam II, Bethesda, PREMM5, MMRpredict, Universal Tumor Screening) will be based on their AUC-ROC values.
- Significance level: p < 0.05.
- Ethical Considerations This study adheres to Good Clinical Practice (GCP) and the Declaration of Helsinki. Ethical approval has been obtained from the Institutional Review Board (IRB), and all participants will provide written informed consent.
- Patient confidentiality will be ensured by de-identifying all study data.
- All data will be retained for at least three years post-study completion. Data Quality and Monitoring
- Standard Operating Procedures (SOPs): Guidelines will be followed for sample collection, DNA extraction, MSI/IHC testing, and genetic analysis.
- Plan for Missing Data: Cases with missing or inconsistent data will be reviewed, and statistical methods such as multiple imputation will be used if necessary.
- Registry Oversight \& Compliance: The study will follow national biomedical research regulations and ensure compliance with international registry requirements (e.g., ClinicalTrials.gov).
- Study Duration and Expected Outcomes
- Study Duration: 24 months (March 2025 - March 2027).
- Expected Outcomes:
- Improved LS detection rates in Vietnamese CRC patients.
- Validation of prediction models (PREMM5, MMRpredict) in the Vietnamese population.
- Enhanced cost-effectiveness in LS screening and genetic testing selection.
- Contribution to national screening guidelines for hereditary cancer syndromes. By refining LS screening strategies, this study will support early cancer detection, preventive interventions, and genetic counseling in Vietnam.
- Conditions
- Lynch Syndrome, Colorectal Cancer (CRC)
- Keywords
- Lynch Syndrome, Universal Tumor Screening, Colorectal cancer, PREMM5, MMRpredict
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Value of PREMM5, MMRpredict, and Universal Tumor Screening for Lynch Syndrome in Colorectal Cancer Patients
The study evaluates the diagnostic accuracy of PREMM5, MMRpredict models, and Universal Tumor Screening (IHC testing) in detecting Lynch Syndrome (LS) in colorectal cancer (CRC) patients. The outcome will be assessed by calculating sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic curve (AUC-ROC) for each screening method compared to gold-standard germline MMR gene mutation testing (via Next-Generation Sequencing - NGS).
Measured: At study completion (Month 24). The primary outcome will be analyzed after all participants have completed sample collection, genetic testing, and data processing, expected within 24 months from study initiation.
Secondary outcomes (4)
Prevalence of Lynch Syndrome in Colorectal Cancer Patients
This outcome measures the proportion of colorectal cancer (CRC) patients diagnosed with Lynch Syndrome (LS) based on germline MMR gene mutation testing (via Next-Generation Sequencing - NGS). The prevalence will be reported as a percentage of the total study population.
Measured: At study completion (Month 24)
Clinical Characteristics of Lynch Syndrome-Associated CRC
This outcome describes the clinical characteristics of Lynch Syndrome-associated CRC vs. sporadic CRC. Key characteristics include age at CRC diagnosis, personal history of cancer and age of onset, family history of cancer and age at diagnosis, and clinical symptoms.
Measured: At study completion (Month 24)
Endoscopic and histopathological features of Lynch Syndrome-Associated CRC
This outcome describes the endoscopic and histopathological features of Lynch Syndrome vs. sporadic CRC tumors. Key characteristics include tumor location, tumor quantity, and histopathological features.
Measured: At study completion (Month 24)
Comparison of Screening Criteria and Prediction Models for Lynch Syndrome
This outcome compares the diagnostic accuracy (sensitivity, specificity, PPV, NPV, and AUC-ROC) of different LS screening methods, including Amsterdam II Criteria, Revised Bethesda Guidelines, PREMM5 Model, MMRpredict Model, and Universal Tumor Screening (IHC testing).
Measured: At study completion (Month 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start17 Mar 2025 (estimated)
- Primary completion17 Mar 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 572 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Gene Solutions
- Responsible party
- Principal investigator, Doan Thi Nha Nguyen, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Doan TN Nguyen, MD, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863038
- Sponsor's protocol ID
- VN_Predict_Lynch_241223
- Acronym
- Predict_LS_VN
- Status last verified
- Mar 2025
- First submitted
- 28 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of the PREMM5, MMRpredict Models, and the Universal Tumor Screening Strategy for Lynch Syndrome in Vietnam
- ClinicalTrials.gov ID
- NCT06863038
- Acronym / sponsor ID
- Predict_LS_VN / VN_Predict_Lynch_241223
- Conditions
- Lynch Syndrome, Colorectal Cancer (CRC)
- Keywords
- Lynch Syndrome, Universal Tumor Screening, Colorectal cancer, PREMM5, MMRpredict
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 572 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Collaborators
- Gene Solutions
- Study start
- 17 Mar 2025 (estimated)
- Primary completion
- 17 Mar 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 7 Mar 2025 (actual)
- 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.
This study evaluates the predictive value of PREMM5, MMRpredict models, and Universal Tumor Screening in detecting Lynch Syndrome in colorectal cancer (CRC) patients in Vietnam.
Vietnamese CRC patients (18-70 years) undergoing colonoscopy will be enrolled. Participants will complete a medical history questionnaire and provide blood samples for genetic testing. Tumor biopsy specimens will undergo Immunohistochemistry staining, BRAF V600E mutation, and MLH1 methylation analysis in case of loss of MLH1/PMS2 expression. Next-Generation Sequencing will detect germline MMR mutations, and biallelic somatic mutations will be analyzed if no germline mutations are found.
Detailed description
- Background and Rationale Colorectal cancer (CRC) is one of the most prevalent malignancies worldwide and the second leading cause of cancer-related deaths. Approximately 5-6% of CRC cases are associated with hereditary cancer syndromes, with Lynch Syndrome (LS) being the most common. LS results from germline mutations in the Mismatch Repair (MMR) genes (MLH1, MSH2, MSH6, PMS2, and EPCAM), which lead to microsatellite instability (MSI) and an increased risk of CRC, endometrial, and other extracolonic malignancies. Despite its significance, LS remains underdiagnosed, particularly in Asian populations, due to the limitations of traditional screening criteria, such as Amsterdam II and the Revised Bethesda Guidelines, which have low sensitivity in identifying LS patients. In response, universal tumor-based screening using MSI testing and immunohistochemistry (IHC) for MMR protein loss has been proposed as an effective alternative. Additionally, prediction models such as PREMM5 and MMRpredict have been developed to estimate LS risk based on clinical and family history. However, these models and tumor screening strategies have not been validated in the Vietnamese population. This study aims to evaluate and compare the predictive performance of different screening approaches for LS in Vietnamese CRC patients, thereby optimizing genetic testing selection and early diagnosis.
- Study Design and Setting This is a cross-sectional study conducted at two major hospitals in Vietnam:
- University Medical Center at Ho Chi Minh City - GI Endoscopy Department
- Nguyen Tri Phuong Hospital - GI Endoscopy \& Gastrointestinal Surgery Departments The study will enroll CRC patients aged 18-70 years who undergo colonoscopy with suspected tumors and are subsequently diagnosed with colorectal adenocarcinoma.
- Objectives Primary Objective:
- To assess the predictive value of PREMM5, MMRpredict, and Universal Tumor Screening Strategy in detecting Lynch Syndrome in CRC patients. Secondary Objectives:
- To determine the prevalence of Lynch Syndrome based on germline MMR gene mutation testing.
- To describe the clinical characteristics of Lynch Syndrome-Associated CRCs.
- To describe the the endoscopic and histopathological features of Lynch Syndrome-Associated CRCs
- To compare the diagnostic accuracy (AUC-ROC, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)) of different screening models and criteria, including Amsterdam II, Revised Bethesda Guidelines, PREMM5, MMRpredict, and Universal Tumor Screening.
- Study Procedures Patient Enrollment \& Sample Collection Eligible patients will:
- Provide informed consent before participation.
- Complete a medical history questionnaire assessing:
- Family history of CRC and LS-related cancers.
- Personal history of CRC, endometrial, and other extracolonic malignancies.
- Clinical symptoms and lifestyle risk factors.
- Provide a 2 mL blood sample for germline genetic testing.
- Laboratory Analysis
- Histopathological Evaluation: Tumor biopsy samples will be fixed in formalin, sectioned, and stained for Hematoxylin-Eosin (H\&E) evaluation.
- MMR Protein Expression: IHC will assess the loss of MLH1, MSH2, MSH6, and PMS2 expression.
- BRAF V600E Mutation \& MLH1 Methylation: Tumors with MLH1/PMS2 loss will undergo further testing to determine sporadic vs. hereditary LS cases.
- Germline MMR Mutation Testing: All the blood samples will undergo Next-Generation Sequencing (NGS) to detect pathogenic germline MMR mutations.
- Biallelic Somatic Mutation Analysis: If no germline mutations are identified in case of MLH1/PMS2 expression loss and no BRAF V600E mutation and no MLH1 methylation, tumor tissue sequencing will determine biallelic somatic inactivation.
- Statistical Considerations Sample Size Calculation The sample size is calculated based on the estimated prevalence of LS at 2.9%, requiring at least 572 participants (including a 10% dropout rate) to achieve statistical power.
- Statistical Analysis
- Quantitative variables (e.g., age, tumor size) will be expressed as mean ± standard deviation or median with interquartile range.
- Categorical variables (e.g., IHC results, BRAF V600E mutation) will be reported as percentages.
- Diagnostic performance will be evaluated using Receiver Operating Characteristic (ROC) curves, sensitivity, specificity, PPV, and NPV.
- Comparison of screening models (Amsterdam II, Bethesda, PREMM5, MMRpredict, Universal Tumor Screening) will be based on their AUC-ROC values.
- Significance level: p < 0.05.
- Ethical Considerations This study adheres to Good Clinical Practice (GCP) and the Declaration of Helsinki. Ethical approval has been obtained from the Institutional Review Board (IRB), and all participants will provide written informed consent.
- Patient confidentiality will be ensured by de-identifying all study data.
- All data will be retained for at least three years post-study completion. Data Quality and Monitoring
- Standard Operating Procedures (SOPs): Guidelines will be followed for sample collection, DNA extraction, MSI/IHC testing, and genetic analysis.
- Plan for Missing Data: Cases with missing or inconsistent data will be reviewed, and statistical methods such as multiple imputation will be used if necessary.
- Registry Oversight \& Compliance: The study will follow national biomedical research regulations and ensure compliance with international registry requirements (e.g., ClinicalTrials.gov).
- Study Duration and Expected Outcomes
- Study Duration: 24 months (March 2025 - March 2027).
- Expected Outcomes:
- Improved LS detection rates in Vietnamese CRC patients.
- Validation of prediction models (PREMM5, MMRpredict) in the Vietnamese population.
- Enhanced cost-effectiveness in LS screening and genetic testing selection.
- Contribution to national screening guidelines for hereditary cancer syndromes. By refining LS screening strategies, this study will support early cancer detection, preventive interventions, and genetic counseling in Vietnam.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include Vietnamese patients aged 18-70 years who undergo colonoscopy at the University Medical Center Ho Chi Minh City and Nguyen Tri Phuong Hospital with suspected colorectal tumors. Eligible participants will be those diagnosed with colorectal adenocarcinoma through biopsy.
Key inclusion criteria (4 listed)
- Aged 18 to 70 years
- Provide informed consent to participate in the study
- Undergo colonoscopy with endoscopic findings suspicious for CRC
- Have biopsy-confirmed adenocarcinoma through colonoscopic biopsy
Key exclusion criteria (4 listed)
- Active gastrointestinal bleeding
- Currently using anticoagulants or antiplatelet agents
- History of coagulation disorders or difficulty controlling bleeding
- Incomplete colonoscopy to the cecum (excluding cases of tumor-induced obstruction)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive Value of PREMM5, MMRpredict, and Universal Tumor Screening for Lynch Syndrome in Colorectal Cancer Patients
Time frame: At study completion (Month 24). The primary outcome will be analyzed after all participants have completed sample collection, genetic testing, and data processing, expected within 24 months from study initiation.
The study evaluates the diagnostic accuracy of PREMM5, MMRpredict models, and Universal Tumor Screening (IHC testing) in detecting Lynch Syndrome (LS) in colorectal cancer (CRC) patients. The outcome will be assessed by calculating sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic curve (AUC-ROC) for each screening method compared to gold-standard germline MMR gene mutation testing (via Next-Generation Sequencing - NGS).
4 secondary outcomes
Prevalence of Lynch Syndrome in Colorectal Cancer Patients
Time frame: At study completion (Month 24)
Clinical Characteristics of Lynch Syndrome-Associated CRC
Time frame: At study completion (Month 24)
Endoscopic and histopathological features of Lynch Syndrome-Associated CRC
Time frame: At study completion (Month 24)
Comparison of Screening Criteria and Prediction Models for Lynch Syndrome
Time frame: At study completion (Month 24)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Doan TN Nguyen, MD principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lynch Syndrome and Colorectal Cancer (CRC), run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 4 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: opening soon, as of the sponsor's last update on 7 Mar 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 Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doan TN Nguyen, MD (+84918206883, nhadoannguyen@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Value of PREMM5, MMRpredict, and Universal Tumor Screening for Lynch Syndrome in Colorectal Cancer Patients (time frame: At study completion (Month 24). The primary outcome will be analyzed after all participants have completed sample collection, genetic testing, and data processing, expected within 24 months from study initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2025.