Prostate CarcinomaNCT04699344
A Prospective, Single-centre，Single-blinded Study of PROUD for Prostate Carcinoma Diagnosis
An observational study of Prostate Carcinoma, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Prostate carcinoma (PC) is common malignancy and is considered to be the highest incidence in the old males. The traditional diagnostic methods of PC present with some shortcomings. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- The level of CNV
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2021to 30 Jun 2023
- Phase
- Observational
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with prostate carcinoma or participants in control group from January 2021 to June 2023 in Qilu hospital.
Who may be able to join
- Patients suspected with prostate cancer and planned to undergo prostate needle biopsy.
- Patient with serum PSA test result.
- Patient willing to provide morning urine sample before biopsy, and willing to provide patient information.
- Participants without any tumor disease and willing to attend the study by providing morning urine.
- Male patients aged >= 18 years.
- Participants signed informed consent form.
Who cannot join
- Age under 18 years
- Individuals unwilling to sign the consent form or unwilling to provide morning urine for test or unwilling to provide the medical record.
- Patient already received urethral catheterization.
- Patient with late-stage uremia and need regular dialysis.
- Patient with urothelial carcinoma or suspected urothelial carcinoma.
- Suspected PC patient with endocrine therapy without histological results of the prostate.
- PC patient after any related therapy: endocrine therapy, radiotherapy, radical operation, immunotherapy, chemotherapy, transurethral prostate surgery, cryoablation or other local therapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Urology Department of Qiluhospital
Jinan, Shandong, 250012
Yueqing Tang, MD, +8618560083899, sdurology@163.com
Zunlin Zhou, MD, +8618560083921, zunlin117@163.com
About this study
Official title: A Prospective, Single-centre,Single-blinded Study of PROUD for Prostate Carcinoma Diagnosis
Prostate carcinoma (PC) is common malignancy and is considered to be the highest incidence in the old males. The traditional diagnostic methods of PC present with some shortcomings. For example, the specificity of serum PSA remains low while prostate needle biopsy is invasive and false negative in some case, even causing missed diagnosis of some high risk PC, and over diagnosis of PC is not rare. Therefore, a noninvasive diagnostic method with high accuracy is urgently needed. Our previous study has proved that PROstate cancer Urine Detector (PROUD), which is able to detect chromosomal aberrations of the urine exfoliated cells, is a reliable method in diagnosing urothelial carcinoma with sensitivity and specificity of 82.5% and 96.9%, respectively. But its potential in PC diagnosis hasn't been assessed yet and the accuracy of PROUD in detecting PC need to be validated. We here intended to investigate whether PROUD can be used in PC diagnosis and further validate the accuracy of PROUD in diagnosing PC.
Read the detailed description
The traditional diagnostic methods of PC include serum PSA and prostatic biopsy (PB). To screen the PC in high risk population, PSA is commonly used. The early detection of PC is actually carried out by the association of digital rectal examination (DRE) and serum total prostate-specific antigen (tPSA) level. The usual upper limit for tPSA is 4 ng ml-1. However, between 4 and 10 ng ml-1, there exists a diagnostic grey zone with an estimated probability of only 40% of PC in men with normal findings on DRE. Prostrate cancer can only be accurately differentiated from benign prostate hyperplasia(BPH) and prostatitis by pathological proof, usually obtained by subsequent invasive PB. To refine the indications for PB, and therefore to reduce morbidity, new indicators based on tPSA were developed: age-adjusted tPSA cutoffs, tPSA velocity or tPSA density where the elevated tPSA is indexed to the gland size. The most commonly used indicator is free/total PSA ratio (f/tPSA), which may help to predict PC or BPH in its extreme values. However, the probability of PC at biopsy among men with a PSA value between 4 and 10 ng ml-1 and normal findings on DRE ranged from 56% for men with an f/tPSA ratio of <10% to 8% for men with a ratio >25%, underlying the lack of accuracy of the f/tPSA indicator. PB is the "gold standard" diagnostic procedure, which is invasive, uncomfortable and with possible adverse side effects as local bleeding and infectious complications including drug resistant bacterial strains. Furthermore, repeated tissue biopsy is needed in some cases for the missed diagnosis of PC, in the other hand, causing over diagnosis of the insignificant clinical PC cases.
The difficulty of estimating the risk of PC when there is a suspicious DRE without nodule, when tPSA ranges between 4 and 10 ng ml-1 or when f/tPSA has an average value (between 15 and 25%), taken together with the morbidity due to PB, highlights the need of new predictive markers for PC.
In urine samples, it is reported than whole-genome gene expression analysis, as noninvasive method, obtained from PC, BPH,and control groups by using the microarray system, showed the differences of gene expression profiles.To improve the specificity of prostate cancer diagnosis, prostate-cancer-specific markers, such as prostate cancer gene 3 (PCA3),are needed. The strong association between PCA3 mRNA overexpression and malignant transformation of prostate epithelium indicates its potential as a diagnostic biomarker. The PCA3 test of PC has a sensitivity ranged from 47%-69% and specificity from 72%-83%.
Copy number variations (CNVs) refers to the ongoing acquisition of genomic alterations ranging from point mutations to gross chromosomal rearrangements, is a hallmark of cancer which is found in 60-80% of human cancer, and it positively correlates with high tumor stage, poor prognosis, metastasis and therapeutic resistance. Several researches have investigated the value of detecting chromosomal instability with sWGS in either cell-free (cf)DNA or genomic DNA as a noninvasive diagnostic method for cancers and yielded quite fine results. Our previous research has also proved the PROUD model reached performance of AUC=0.928, with sensitivity, specificity and accuracy of 82.5%, 96.9% and 89.0%, respectively. This test also showed superiority in diagnosing upper tract urothelial carcinoma compared with urinary cytology test.
Here we intended to conduct a prospective, multicenter, single-blinded research to further validate the value of PROUD in diagnosing PC by analyzing the CNV level of patient DNA extracted from urine exfoliated cells.
- Conditions
- Prostate Carcinoma
- Being tested
- The level of CNV
- Keywords
- diagnosis
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The level of CNVDiagnostic test
Also called PROUD test of the urine exfoliated cells
The extracted DNA from morning urine will be analyzed by PROUD to determine the level of CNV.
| Study group | Role | What they receive |
|---|---|---|
| Pre-tissue biopsy patients | Pre-tissue biopsy patients with suspected prostate carcinoma will be the experimental group to determine the sensitivity and specificity of PROUD analysis, the result will be compared with histological results and PCA3 test. Receives: Diagnostic Test: The level of CNV | |
| Non-cancer participants | Patients being treated for other diseases but without any tumor will provide a negative control to provide data for determining the sensitivity and specificity of PROUD analysis. Receives: Diagnostic Test: The level of CNV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of urinalysis by PROUD analysis
number of patients "declared positive" with the PROUD test among the patients suffered from prostate cancer.
Measured: through study completion, an average of 30 months
Specificity of urinalysis by PROUD analysis
number of patients "declared negative" with the PROUD test among the patients without cancer.
Measured: through study completion, an average of 30 months
Identification of the correlation between the level of CNV and the grade (Gleason Score,GS) of the tumor sample
level of CNV in the urine sample compared with the grade of the tumor confirmed by histopathologic examination.
Measured: through study completion, an average of 30 months
Identification of the correlation between the level of CNV and the stage (TNM) of the tumor sample.
through study completion, an average of 30 months
Measured: level of CNV in the urine sample compared with the stage of the tumor confirmed by histopathologic examination.
Comparison of the sensitivity of the PROUD analysis versus urine PCA3
number of patients "declared positive" with the PROUD analysis versus patients "declared positive" with the PCA3 test.
Measured: through study completion, an average of 30 months
Comparison of the specificity of the PROUD analysis versus urine PCA3
number of patients "declared negative" with the PROUD analysis versus patients " declared negative " with the PCA3 test.
Measured: through study completion, an average of 30 months
Sensitivity of the PROUD analysis in different PSA subgroup(≤4,≥10，between 4-10ng ml-1)
number of patients "declared positive" with the PROUD test among the patients suffered from prostate cancer in different PSA subgroup(≤4,≥10，between 4-10ng ml-1).
Measured: through study completion, an average of 30 months
Specificity of the PROUD analysis in different PSA subgroup(≤4,≥10，between 4-10ng ml-1).
number of patients "declared negative" with the PROUD test among the patients without cancer in different PSA subgroup(≤4,≥10，between 4-10ng ml-1).
Measured: through study completion, an average of 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start25 Jan 2021 (estimated)
- Primary completion31 Jan 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
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 Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yueqing Tang, Qilu Hospital of Shandong University
- Investigators
- Zunlin Zhou, MD, Study chair, Qiluhospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699344
- Sponsor's protocol ID
- QL-URO-001
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will try to protect the information of the included participants
Publications
Zeng S, Ying Y, Xing N, Wang B, Qian Z, Zhou Z, Zhang Z, Xu W, Wang H, Dai L, Gao L, Zhou T, Ji J, Xu C. Noninvasive Detection of Urothelial Carcinoma by Cost-effective Low-coverage Whole-genome Sequencing from Urine-Exfoliated Cell DNA. Clin Cancer Res. 2020 Nov 1;26(21):5646-5654. doi: 10.1158/1078-0432.CCR-20-0401. Epub 2020 Oct 9.
PubMed 33037018Thuret R, Chantrel-Groussard K, Azzouzi AR, Villette JM, Guimard S, Teillac P, Berthon P, Houlgatte A, Latil A, Cussenot O. Clinical relevance of genetic instability in prostatic cells obtained by prostatic massage in early prostate cancer. Br J Cancer. 2005 Jan 31;92(2):236-40. doi: 10.1038/sj.bjc.6602311.
PubMed 15655554Hessels D, Schalken JA. The use of PCA3 in the diagnosis of prostate cancer. Nat Rev Urol. 2009 May;6(5):255-61. doi: 10.1038/nrurol.2009.40.
PubMed 19424173Ozdemir TR, Simsir A, Onay H, Cureklibatir I, Ozkinay F, Akin H. Whole-genome gene expression analysis in urine samples of patients with prostate cancer and benign prostate hyperplasia. Urol Oncol. 2017 Oct;35(10):607.e15-607.e24. doi: 10.1016/j.urolonc.2017.05.020. Epub 2017 Jun 21.
PubMed 28647394
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-centre,Single-blinded Study of PROUD for Prostate Carcinoma Diagnosis
- ClinicalTrials.gov ID
- NCT04699344
- Acronym / sponsor ID
- QL-URO-001
- Conditions
- Prostate Carcinoma
- Keywords
- diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 25 Jan 2021 (estimated)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 7 Jan 2021 (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.
Prostate carcinoma (PC) is common malignancy and is considered to be the highest incidence in the old males. The traditional diagnostic methods of PC present with some shortcomings. For example, the specificity of serum PSA remains low while prostate needle biopsy is invasive and false negative in some case, even causing missed diagnosis of some high risk PC, and over diagnosis of PC is not rare. Therefore, a noninvasive diagnostic method with high accuracy is urgently needed. Our previous study has proved that PROstate cancer Urine Detector (PROUD), which is able to detect chromosomal aberrations of the urine exfoliated cells, is a reliable method in diagnosing urothelial carcinoma with sensitivity and specificity of 82.5% and 96.9%, respectively. But its potential in PC diagnosis hasn't been assessed yet and the accuracy of PROUD in detecting PC need to be validated. We here intended to investigate whether PROUD can be used in PC diagnosis and further validate the accuracy of PROUD in diagnosing PC.
Detailed description
The traditional diagnostic methods of PC include serum PSA and prostatic biopsy (PB). To screen the PC in high risk population, PSA is commonly used. The early detection of PC is actually carried out by the association of digital rectal examination (DRE) and serum total prostate-specific antigen (tPSA) level. The usual upper limit for tPSA is 4 ng ml-1. However, between 4 and 10 ng ml-1, there exists a diagnostic grey zone with an estimated probability of only 40% of PC in men with normal findings on DRE. Prostrate cancer can only be accurately differentiated from benign prostate hyperplasia(BPH) and prostatitis by pathological proof, usually obtained by subsequent invasive PB. To refine the indications for PB, and therefore to reduce morbidity, new indicators based on tPSA were developed: age-adjusted tPSA cutoffs, tPSA velocity or tPSA density where the elevated tPSA is indexed to the gland size. The most commonly used indicator is free/total PSA ratio (f/tPSA), which may help to predict PC or BPH in its extreme values. However, the probability of PC at biopsy among men with a PSA value between 4 and 10 ng ml-1 and normal findings on DRE ranged from 56% for men with an f/tPSA ratio of <10% to 8% for men with a ratio >25%, underlying the lack of accuracy of the f/tPSA indicator. PB is the "gold standard" diagnostic procedure, which is invasive, uncomfortable and with possible adverse side effects as local bleeding and infectious complications including drug resistant bacterial strains. Furthermore, repeated tissue biopsy is needed in some cases for the missed diagnosis of PC, in the other hand, causing over diagnosis of the insignificant clinical PC cases.
The difficulty of estimating the risk of PC when there is a suspicious DRE without nodule, when tPSA ranges between 4 and 10 ng ml-1 or when f/tPSA has an average value (between 15 and 25%), taken together with the morbidity due to PB, highlights the need of new predictive markers for PC.
In urine samples, it is reported than whole-genome gene expression analysis, as noninvasive method, obtained from PC, BPH,and control groups by using the microarray system, showed the differences of gene expression profiles.To improve the specificity of prostate cancer diagnosis, prostate-cancer-specific markers, such as prostate cancer gene 3 (PCA3),are needed. The strong association between PCA3 mRNA overexpression and malignant transformation of prostate epithelium indicates its potential as a diagnostic biomarker. The PCA3 test of PC has a sensitivity ranged from 47%-69% and specificity from 72%-83%.
Copy number variations (CNVs) refers to the ongoing acquisition of genomic alterations ranging from point mutations to gross chromosomal rearrangements, is a hallmark of cancer which is found in 60-80% of human cancer, and it positively correlates with high tumor stage, poor prognosis, metastasis and therapeutic resistance. Several researches have investigated the value of detecting chromosomal instability with sWGS in either cell-free (cf)DNA or genomic DNA as a noninvasive diagnostic method for cancers and yielded quite fine results. Our previous research has also proved the PROUD model reached performance of AUC=0.928, with sensitivity, specificity and accuracy of 82.5%, 96.9% and 89.0%, respectively. This test also showed superiority in diagnosing upper tract urothelial carcinoma compared with urinary cytology test.
Here we intended to conduct a prospective, multicenter, single-blinded research to further validate the value of PROUD in diagnosing PC by analyzing the CNV level of patient DNA extracted from urine exfoliated cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-tissue biopsy patients | – | Diagnostic Test: The level of CNVPre-tissue biopsy patients with suspected prostate carcinoma will be the experimental group to determine the sensitivity and specificity of PROUD analysis, the result will be compared with histological results and PCA3 test. |
| Non-cancer participants | – | Diagnostic Test: The level of CNVPatients being treated for other diseases but without any tumor will provide a negative control to provide data for determining the sensitivity and specificity of PROUD analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with prostate carcinoma or participants in control group from January 2021 to June 2023 in Qilu hospital.
Key inclusion criteria (6 listed)
- Patients suspected with prostate cancer and planned to undergo prostate needle biopsy.
- Patient with serum PSA test result.
- Patient willing to provide morning urine sample before biopsy, and willing to provide patient information.
- Participants without any tumor disease and willing to attend the study by providing morning urine.
- Male patients aged >= 18 years.
Key exclusion criteria (7 listed)
- Age under 18 years
- Individuals unwilling to sign the consent form or unwilling to provide morning urine for test or unwilling to provide the medical record.
- Patient already received urethral catheterization.
- Patient with late-stage uremia and need regular dialysis.
- Patient with urothelial carcinoma or suspected urothelial carcinoma.
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 |
|---|---|---|
| The level of CNVAlso: PROUD test of the urine exfoliated cellsThe extracted DNA from morning urine will be analyzed by PROUD to determine the level of CNV. | Diagnostic test | Non-cancer participants, Pre-tissue biopsy patients |
Primary outcome
Sensitivity of urinalysis by PROUD analysis
Time frame: through study completion, an average of 30 months
number of patients "declared positive" with the PROUD test among the patients suffered from prostate cancer.
Specificity of urinalysis by PROUD analysis
Time frame: through study completion, an average of 30 months
number of patients "declared negative" with the PROUD test among the patients without cancer.
Identification of the correlation between the level of CNV and the grade (Gleason Score,GS) of the tumor sample
Time frame: through study completion, an average of 30 months
level of CNV in the urine sample compared with the grade of the tumor confirmed by histopathologic examination.
Identification of the correlation between the level of CNV and the stage (TNM) of the tumor sample.
Time frame: level of CNV in the urine sample compared with the stage of the tumor confirmed by histopathologic examination.
through study completion, an average of 30 months
Comparison of the sensitivity of the PROUD analysis versus urine PCA3
Time frame: through study completion, an average of 30 months
number of patients "declared positive" with the PROUD analysis versus patients "declared positive" with the PCA3 test.
Comparison of the specificity of the PROUD analysis versus urine PCA3
Time frame: through study completion, an average of 30 months
number of patients "declared negative" with the PROUD analysis versus patients " declared negative " with the PCA3 test.
Sensitivity of the PROUD analysis in different PSA subgroup(≤4,≥10，between 4-10ng ml-1)
Time frame: through study completion, an average of 30 months
number of patients "declared positive" with the PROUD test among the patients suffered from prostate cancer in different PSA subgroup(≤4,≥10，between 4-10ng ml-1).
Specificity of the PROUD analysis in different PSA subgroup(≤4,≥10，between 4-10ng ml-1).
Time frame: through study completion, an average of 30 months
number of patients "declared negative" with the PROUD test among the patients without cancer in different PSA subgroup(≤4,≥10，between 4-10ng ml-1).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Results publication: PubMed 33037018Zeng S, Ying Y, Xing N, Wang B, Qian Z, Zhou Z, Zhang Z, Xu W, Wang H, Dai L, Gao L, Zhou T, Ji J, Xu C. Noninvasive Detection of Urothelial Carcinoma by Cost-effective Low-coverage Whole-genome Sequencing from Urine-Exfoliated Cell DNA. Clin Cancer Res. 2020 Nov 1;26(21):5646-5654. doi: 10.1158/1078-0432.CCR-20-0401. Epub 2020 Oct 9.
- Results publication: PubMed 15655554Thuret R, Chantrel-Groussard K, Azzouzi AR, Villette JM, Guimard S, Teillac P, Berthon P, Houlgatte A, Latil A, Cussenot O. Clinical relevance of genetic instability in prostatic cells obtained by prostatic massage in early prostate cancer. Br J Cancer. 2005 Jan 31;92(2):236-40. doi: 10.1038/sj.bjc.6602311.
- Results publication: PubMed 19424173Hessels D, Schalken JA. The use of PCA3 in the diagnosis of prostate cancer. Nat Rev Urol. 2009 May;6(5):255-61. doi: 10.1038/nrurol.2009.40.
- Results publication: PubMed 28647394Ozdemir TR, Simsir A, Onay H, Cureklibatir I, Ozkinay F, Akin H. Whole-genome gene expression analysis in urine samples of patients with prostate cancer and benign prostate hyperplasia. Urol Oncol. 2017 Oct;35(10):607.e15-607.e24. doi: 10.1016/j.urolonc.2017.05.020. Epub 2017 Jun 21.
- Individual participant dataSharing planned: No. We will try to protect the information of the included participants
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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.
Zunlin Zhou, MD study chair
Qiluhospital of Shandong University
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 Prostate Carcinoma, run by Qilu Hospital of Shandong University at 1 site in China.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Jan 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yueqing Tang, MD (+8618560083899, sdurology@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of urinalysis by PROUD analysis (time frame: through study completion, an average of 30 months). The study lists 8 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 NCT04699344, 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 7 Jan 2021.