Colorectal AdenomaPhase 2NCT02134925
Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps
A Phase 2 study testing Laboratory Biomarker Analysis, MUC1 Peptide-Poly-ICLC Vaccine and Quality-of-Life Assessment in people with Colorectal Adenoma and Colorectal Carcinoma, run by National Cancer Institute (NCI) at 7 sites in 2 countries.
Trial summary
This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer over time. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Colorectal Adenoma, Colorectal Carcinoma, Colorectal Conventional Adenoma With Severe Dysplasia
- What is being tested?
- Laboratory Biomarker Analysis, MUC1 Peptide-Poly-ICLC Vaccine and Quality-of-Life Assessment
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 23 Jun 2014to 9 Mar 2027
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of at least one of the following conditions in the previous 12 months:
- Colorectal adenoma(s) >= 1 cm in maximal diameter
- Colorectal adenoma(s) with villous or tubulovillous histology
- Colorectal adenoma(s) with high grade (severe) dysplasia
- Presumptive evidence that all adenomatous lesions, including qualifying advanced adenoma, have been completely removed
- Ability to understand and the willingness to sign a written informed consent document
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- Willingness to undergo screening tests and procedures
- Willingness to provide blood samples for toxicity monitoring and research purposes
- Not pregnant or nursing; note: a negative (serum or urine) pregnancy test must be documented =< 7 days prior to registration/randomization for women of childbearing potential
- Willingness to employ adequate contraception through week 53 of the study; note: women of childbearing potential and men must agree to use adequate contraception (hormonal, barrier method of birth control, abstinence) prior to study entry and for the period of active vaccination (through week 53); should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her physician immediately
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
- Hemoglobin greater than 90% of the lower limit of institutional normal
- Platelets >= 100 B/L (10^9/L)
- White blood cell (WBC) > 2.5 B/L (10^9/L)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x institutional upper limit of normal
- Alkaline phosphatase =< 1.5 x institutional upper limit of normal
- Total bilirubin =< 1.5 x institutional upper limit of normal
- Blood urea nitrogen (BUN) =< 1.5 x institutional upper limit of normal
- Creatinine =< 1.5 x institutional upper limit of normal
- Antinuclear antibody (ANA) test result excludes overt autoimmune disease; note: test result may be reported in any of the following formats: =< 1:160, negative, or < 1.0
Who cannot join
- History of any colorectal cancer
- History of other malignancy =< 5 years prior to the registration/randomization evaluation, with the exception of basal cell or squamous cell skin cancer
- Presence of an active acute or chronic infection or uncontrolled illness including, but not limited to unstable congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Acquired immunosuppressive diseases such as active human immunodeficiency virus (HIV) infection or congenital diseases of immunity
- History of heritable cancer syndrome (familial adenomatous polyposis [FAP], hereditary nonpolyposis colorectal cancer [HNPCC])
- History of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, multiple sclerosis, Hashimoto's thyroiditis, or Grave's disease
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- Current or planned use of immunomodulators including: infliximab, 6-MP (mercaptopurine), methotrexate, cyclosporine, or other immunomodulatory drugs
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent
- Pregnant women
- Breastfeeding women
- Diagnosis of nonalcoholic steatohepatitis (NASH) and a NAFLD (nonalcoholic fatty liver disease) activity score (NAS) >= 5; NOTES and EXCEPTIONS: NAS is based on findings from a liver biopsy; participants with NAS of =< 2 are eligible for enrollment; participants with NAS of 3-4 must be discussed with the principal investigator and Division of Cancer Prevention (DCP) before enrollment to consider other risk factors (i.e., obesity, alcohol intake); participants with a prior diagnosis of NASH and no available NAS must be discussed with the principal investigator and DCP before enrollment to considered risk factors (i.e., obesity, alcohol intake)
- Receiving any other investigational agent =< 3 months prior to registration/randomization, except innocuous agents with no known interaction with the study agent (e.g., standard dose multivitamins or topical agents for limited skin conditions)
- Any use of oral corticosteroids =< 12 weeks prior to registration/randomization
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of MUC1 Vaccine in Patients With Newly Diagnosed Advanced Adenomas
This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer over time. Vaccines made from peptides may help the body build an effective immune response to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare the immunogenicity at week 12 of a MUC1 peptide vaccine with adjuvant (MUC1 peptide-poly-ICLC adjuvant vaccine) (administered at 0, 2, and 10 weeks) in participants with a history of an advanced adenoma, randomized to receive MUC1 peptide vaccine versus placebo.
SECONDARY OBJECTIVES:
- To evaluate the ability of the vaccine to elicit a long-term memory response.
II. To compare the adenoma recurrence rate from surveillance exams occurring at least 1 year and up to 3 years after week 0 vaccine administration - MUC1 versus placebo.
III. To compare the adenoma recurrence rates between MUC1 and placebo by excluding the following types of adenomas: participants with adenomas =< 5 mm; participants with adenomatous tissue which may represent residual adenoma at the site of the previous advanced adenoma; participants with adenomatous tissue detected in the same segment of the bowel as the previous advanced adenoma.
IV. To assess adverse events to the MUC1 peptide vaccine in comparison to placebo during Parts I and II.
- To assess patient reported injection site reaction events from the Vaccine Report Card.
TERTIARY OBJECTIVES:
- To compare the anti-MUC1 antibody titer at the time of surveillance colonoscopy for the purpose of evaluating the anti-MUC1 antibody response in relation to adenoma recurrence.
II. To evaluate MUC1 expression on baseline advanced adenomas and on recurrent adenomas detected at surveillance colonoscopy.
III. To evaluate levels of circulating myeloid derived suppressor cells (MDSC) in the vaccinated and the placebo group and correlate with anti-MUC1 antibody levels and adenoma recurrence.
IV. To establish a biospecimen repository archive including live cells, plasma, and germline deoxyribonucleic acid (DNA) for future immunologic (e.g. MUC1-specific T cells) and other assays (systems biology approach to detect differences between responders and non-responders), testing not currently accommodated within the budget of this trial.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Participants receive MUC1 peptide-poly-ICLC adjuvant vaccine subcutaneously (SC) in weeks 0, 2 and 10 and a booster injection in week 53.
ARM II: Participants receive saline SC in weeks 0, 2, and 10 and a booster injection in week 53.
After completion of treatment, patients are followed up every 6 months for up to 3 years.
- Conditions
- Colorectal Adenoma, Colorectal Carcinoma, Colorectal Conventional Adenoma With Severe Dysplasia, Colorectal Tubulovillous Adenoma
- Being tested
- Laboratory Biomarker Analysis, MUC1 Peptide-Poly-ICLC Vaccine, Quality-of-Life Assessment, Saline
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
MUC1 Peptide-Poly-ICLC VaccineBiological
Given SC
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
SalineOther
Also called ISOTONIC SODIUM CHLORIDE SOLUTION, Normal Saline, Sodium Chloride 0.9%
Given SC
| Study group | Role | What they receive |
|---|---|---|
| Arm I (MUC1 peptide-poly-ILCLC adjuvant vaccine) | Experimental | Participants receive MUC1 peptide-poly-ICLC adjuvant vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53. Receives: Other: Laboratory Biomarker Analysis; Biological: MUC1 Peptide-Poly-ICLC Vaccine; Other: Quality-of-Life Assessment |
| Arm II (saline) | Placebo comparator | Participants receive saline SC in weeks 0, 2, and 10 and a booster injection in week 53. Receives: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anti-MUC1 Immunoglobulin G (IgG) Levels as Determined by Enzyme-linked Immunosorbent Assay (ELISA)
The ratio of the week 12 to week 0 IgG levels will be calculated and compared between the MUC1 vaccine and placebo. The Wilcoxon Rank-Sum test will be used. For all measurements of response (i.e. the primary endpoint), the 95% confidence intervals will also be provided.
Measured: Week 0 to week 12
Secondary outcomes (5)
Adenoma Recurrence Rate
The secondary endpoint for Part 3 will evaluate the adenoma recurrence rate from surveillance exams. The rate is defined as the percentage of participants with adenoma recurrence.
Measured: At least one year and up to 3 years
Booster Response
The key secondary endpoint for Part 2 will assess the booster response at week 55 vs. week 52 for the vaccine as compared to placebo. The IgG ratios are summarized according to the following categories : <1, 1-<1.5, 1.5-<2, and >=2 (1-year response rate).
Measured: At week 55
Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site
Participant-reported injection site reaction information is collected by the use of a participant-completed Vaccine Report Card. Participant-reported injection site reactions will be compared between study arms and are summarized below for redness at the injection site, swelling/induration, itching at site, and skin warmth at site.
Measured: Up to 55 weeks
Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch)
Participant-reported injection site reaction information is collected by the use of a participant-completed Vaccine Report Card. Participant-reported injection site reactions will be compared between study arms and are summarized below for pain at the injection site without touching, and tenderness (pain at the injection site with touch).
Measured: Up to 55 weeks
Number of Patients With at Least a 2-Fold Increase in the IgG Ratio
The frequency and percentage of patients with at least a 2-fold increase in the IgG Ratio will be calculated and compared between the MUC1 vaccine and placebo. The Fisher's exact test will be used.
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study start23 Jun 2014
- Primary completion27 Jan 2017
- Study completion9 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert E Schoen, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134925
- Sponsor's protocol ID
- NCI-2014-01080
- Other IDs
- NCI-2014-01080, HHSN261201200042I, N01-CN-2012-00042, MAY2013-01-01, MAY2013-01-01, N01CN00042, P30CA015083
- Status last verified
- Sep 2026
- First submitted
- 7 May 2014
- Last updated
- 11 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Trial of MUC1 Vaccine in Patients With Newly Diagnosed Advanced Adenomas
- ClinicalTrials.gov ID
- NCT02134925
- Acronym / sponsor ID
- NCI-2014-01080
- Conditions
- Colorectal Adenoma, Colorectal Carcinoma, Colorectal Conventional Adenoma With Severe Dysplasia, Colorectal Tubulovillous Adenoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 23 Jun 2014 (actual)
- Primary completion
- 27 Jan 2017 (actual)
- Study completion
- 9 Mar 2027 (estimated)
- First posted
- 9 May 2014 (estimated)
- Results
- Posted 18 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer over time. Vaccines made from peptides may help the body build an effective immune response to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer.
Detailed description
PRIMARY OBJECTIVES:
- To compare the immunogenicity at week 12 of a MUC1 peptide vaccine with adjuvant (MUC1 peptide-poly-ICLC adjuvant vaccine) (administered at 0, 2, and 10 weeks) in participants with a history of an advanced adenoma, randomized to receive MUC1 peptide vaccine versus placebo.
SECONDARY OBJECTIVES:
- To evaluate the ability of the vaccine to elicit a long-term memory response.
II. To compare the adenoma recurrence rate from surveillance exams occurring at least 1 year and up to 3 years after week 0 vaccine administration - MUC1 versus placebo.
III. To compare the adenoma recurrence rates between MUC1 and placebo by excluding the following types of adenomas: participants with adenomas =< 5 mm; participants with adenomatous tissue which may represent residual adenoma at the site of the previous advanced adenoma; participants with adenomatous tissue detected in the same segment of the bowel as the previous advanced adenoma.
IV. To assess adverse events to the MUC1 peptide vaccine in comparison to placebo during Parts I and II.
- To assess patient reported injection site reaction events from the Vaccine Report Card.
TERTIARY OBJECTIVES:
- To compare the anti-MUC1 antibody titer at the time of surveillance colonoscopy for the purpose of evaluating the anti-MUC1 antibody response in relation to adenoma recurrence.
II. To evaluate MUC1 expression on baseline advanced adenomas and on recurrent adenomas detected at surveillance colonoscopy.
III. To evaluate levels of circulating myeloid derived suppressor cells (MDSC) in the vaccinated and the placebo group and correlate with anti-MUC1 antibody levels and adenoma recurrence.
IV. To establish a biospecimen repository archive including live cells, plasma, and germline deoxyribonucleic acid (DNA) for future immunologic (e.g. MUC1-specific T cells) and other assays (systems biology approach to detect differences between responders and non-responders), testing not currently accommodated within the budget of this trial.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Participants receive MUC1 peptide-poly-ICLC adjuvant vaccine subcutaneously (SC) in weeks 0, 2 and 10 and a booster injection in week 53.
ARM II: Participants receive saline SC in weeks 0, 2, and 10 and a booster injection in week 53.
After completion of treatment, patients are followed up every 6 months for up to 3 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (MUC1 peptide-poly-ILCLC adjuvant vaccine) | Experimental | Other: Laboratory Biomarker Analysis, Biological: MUC1 Peptide-Poly-ICLC Vaccine, Other: Quality-of-Life AssessmentParticipants receive MUC1 peptide-poly-ICLC adjuvant vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53. |
| Arm II (saline) | Placebo comparator | Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Other: SalineParticipants receive saline SC in weeks 0, 2, and 10 and a booster injection in week 53. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- History of at least one of the following conditions in the previous 12 months:
- Presumptive evidence that all adenomatous lesions, including qualifying advanced adenoma, have been completely removed
- Ability to understand and the willingness to sign a written informed consent document
- Willingness to undergo screening tests and procedures
- Willingness to provide blood samples for toxicity monitoring and research purposes
Key exclusion criteria (13 listed)
- History of any colorectal cancer
- History of other malignancy =< 5 years prior to the registration/randomization evaluation, with the exception of basal cell or squamous cell skin cancer
- Presence of an active acute or chronic infection or uncontrolled illness including, but not limited to unstable congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Acquired immunosuppressive diseases such as active human immunodeficiency virus (HIV) infection or congenital diseases of immunity
- History of heritable cancer syndrome (familial adenomatous polyposis [FAP], hereditary nonpolyposis colorectal cancer [HNPCC])
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 |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (MUC1 peptide-poly-ILCLC adjuvant vaccine), Arm II (saline) |
| MUC1 Peptide-Poly-ICLC VaccineGiven SC | Biological | Arm I (MUC1 peptide-poly-ILCLC adjuvant vaccine) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (MUC1 peptide-poly-ILCLC adjuvant vaccine), Arm II (saline) |
| SalineAlso: ISOTONIC SODIUM CHLORIDE SOLUTION, Normal Saline, Sodium Chloride 0.9%Given SC | Other | Arm II (saline) |
Primary outcome
Change in Anti-MUC1 Immunoglobulin G (IgG) Levels as Determined by Enzyme-linked Immunosorbent Assay (ELISA)
Time frame: Week 0 to week 12
The ratio of the week 12 to week 0 IgG levels will be calculated and compared between the MUC1 vaccine and placebo. The Wilcoxon Rank-Sum test will be used. For all measurements of response (i.e. the primary endpoint), the 95% confidence intervals will also be provided.
5 secondary outcomes
Adenoma Recurrence Rate
Time frame: At least one year and up to 3 years
Booster Response
Time frame: At week 55
Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site
Time frame: Up to 55 weeks
Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch)
Time frame: Up to 55 weeks
Number of Patients With at Least a 2-Fold Increase in the IgG Ratio
Time frame: At 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert E Schoen principal investigator
Mayo Clinic
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laboratory Biomarker Analysis, MUC1 Peptide-Poly-ICLC Vaccine and Quality-of-Life Assessment in people with Colorectal Adenoma and Colorectal Carcinoma, run by National Cancer Institute (NCI) at 7 sites in 2 countries.
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 20 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Puerto Rico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Anti-MUC1 Immunoglobulin G (IgG) Levels as Determined by Enzyme-linked Immunosorbent Assay (ELISA) (time frame: Week 0 to week 12). 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 11 Sep 2026.