Cervical CancerNCT04472455
Mobile High-Resolution Microendoscopy (mHRME) for the Detection of Cervical Dysplasia in El Salvador
An observational study of Cervical Cancer, run by William Marsh Rice University.
Trial summary
Evaluate the performance of the mHRME in a study of 3,000 women in San Salvador to assess whether mHRME imaging improves specificity of screening by VIA or HPV DNA without reducing sensitivity for cervical precancer and cancer. Read more about this study
- Who is it for?
- Ages 30 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- HRME
- How many people
- 1,827 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to 2 Apr 2019
- 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 30 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This is a prospective cohort study. Eligibility is open to women 30-49 years old, who are not pregn ant, have an intact cervix and no history of cervical cancer
Who may be able to join
- Women who are between the ages of 30 and 49 years of age
- All women must have a negative urine or serum pregnancy test prior to any study procedure (within 7 days)
- Intact cervix (patients who have undergone previous LEEP, cone and/ or cryotherapy are not eligible)
- No history of invasive cervical cancer
- Able and willing to provide informed consent
Who cannot join
- Women < 30 years of age or over 49 years of age
- Women who have undergone a hysterectomy with removal of the cervix
- Women who have had a previous LEEP, Cold knife cone and/or cryotherapy
- Women who are pregnant or breastfeeding
- Women with a history of invasive cervical cancer
- Unable or unwilling to provide informed consent
About this study
Evaluate the performance of the mHRME in a study of 3,000 women in San Salvador to assess whether mHRME imaging improves specificity of screening by VIA or HPV DNA without reducing sensitivity for cervical precancer and cancer.
Read the detailed description
This is a prospective cohort study. Eligibility is open to women 30-49 years old, who are not pregnant, have an intact cervix, and no history of cervical cancer.
Visit 1:
Patients will enroll at the screening clinic of the Instituto del Cáncer de El Salvador (El Salvador Cancer Institute, ICES). An informed consent will be obtained. They will be given a urine pregnancy test; if negative, two cervical samples will be collected. The first sample will be used to screen for HPV DNA. New technologies to screen for oncoproteins and HPV will be applied to the second sample. 3-5% acetic acid will also be applied to the cervix to perform the VIA. Images of the cervix will be taken and any personally identifiable information removed.
Visit 2:
All women with a positive VIA or HPV test will undergo additional evaluation. In addition, 10% of women in the double negative group (VIA-/HPV-) will be randomly selected for evaluation. This evaluation includes: Urine pregnancy test, VIA, colposcopy, Lugol's solution application, and a HRME. 3-5% acetic acid will be applied to the cervix to perform the VIA. Proflavine and Lugol's solution (2-5%) will be applied and once again the health care provider will record their impression for each of the abnormal lesions. Cervical images will be taken. Then, 0.01% proflavine will be topically applied to the cervix for 1 minute. Images will be obtained using the mHRME system of a visually normal site and then of all lesions identified by VIA, colposcopy, and/or Lugol's solution. If no lesions are identified by VIA, colposcopy, and/or Lugol's solution, mHRME images will be taken of each quadrant. Samples of abnormal areas identified by VIA, colposcopy, Lugol's solution, and/or mHRME will be collected for biopsy and ECC purposes. If the evaluation shows no abnormalities, a random sample will be collected from the squamocolumnar junction and an ECC will be performed (only if the patient is HPV positive). Two expert pathologists will review and classify the samples. All research results will be unbeknownst to them. They will use the following classification system: normal, CIN 1, CIN 2, CIN 3, AIS, or cancer, per standard criteria. Discrepant results are resolved by a third expert pathologist, with the final result being based on 2/3 agreement. If all three pathologists arrive at different diagnoses, all three will meet in person to review to reach a consensus diagnosis. Women with CIN 2+ will undergo an excision or cryotherapy, according to the treatment standard. Patients diagnosed with invasive cancer will be referred to gynecology/oncology.
The sensitivity, specificity, positive predictive value, and negative predictive value for each screening and triage method will be compared using histopathology as the gold standard. These results will enable us to compare the total number of women that could have received adequate and inadequate treatment based on five of the most predominant clinical scenarios: VIA alone, VIA/mHRME triage, HPV test alone, HPV/VIA triage, and HPV/mHRME triage.
- Conditions
- Cervical Cancer
- Being tested
- HRME
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRMEDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Screen Negative Group | All women who screen negative at Visit 1. Receives: Diagnostic Test: HRME | |
| Screen Positive Group | All women who screened positive at Visit 1 and were invited to Visit 2 Receives: Diagnostic Test: HRME | |
| 10% Of Screen Negative Group | 10% of women who screened negative at Visit 1 and were invited to Visit 2 Receives: Diagnostic Test: HRME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of mHRME to detect CIN2+
Calculate the sensitivity, specificity, positive predictive value, and negative predictive value of mHRME to detect CIN2+.
Measured: 1-2 days
Secondary outcomes (1)
Comparison of different screening and triage strategies to detect CIN2+
Compare the sensitivities and specificities of the following theoretical strategies to detect CIN2+: VIA alone, VIA/mHRME triage, HPV test alone, HPV/VIA triage, and HPV/mHRME triage.
Measured: 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study startSep 2015
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,827 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Marsh Rice University
- Sponsor type
- University, hospital or other
- Collaborators
- Basic Health International, Inc., M.D. Anderson Cancer Center, Albert Einstein College of Medicine, The Cleveland Clinic
- Responsible party
- Principal investigator, Rebecca Richards-Kortum, William Marsh Rice University
- Investigators
- Mauricio Maza, MD, Principal investigator, Basic Health International, Inc.Rebecca Richards-Kortum, PhD, Principal investigator, William Marsh Rice UniversityKathleen Schmeler, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472455
- Sponsor's protocol ID
- 2017-347
- Status last verified
- Jun 2020
- First submitted
- 10 Jul 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: REDCap platform will be used to share data.
Publications
Papanicolaou GN, Traut HF. The diagnostic value of vaginal smears in carcinoma of the uterus. 1941. Arch Pathol Lab Med. 1997 Mar;121(3):211-24. No abstract available.
PubMed 9111103Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
PubMed 21296855Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, Snijders PJ, Peto J, Meijer CJ, Munoz N. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999 Sep;189(1):12-9. doi: 10.1002/(SICI)1096-9896(199909)189:13.0.CO;2-F.
PubMed 10451482FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27. doi: 10.1056/NEJMoa061741.
PubMed 17494925Paavonen J, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter D, Kitchener H, Castellsague X, Teixeira JC, Skinner SR, Hedrick J, Jaisamrarn U, Limson G, Garland S, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, Jenkins D, Hardt K, Zahaf T, Descamps D, Struyf F, Lehtinen M, Dubin G; HPV PATRICIA Study Group. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet. 2009 Jul 25;374(9686):301-14. doi: 10.1016/S0140-6736(09)61248-4. Epub 2009 Jul 6.
PubMed 19586656Chou B, Krill LS, Horton BB, Barat CE, Trimble CL. Disparities in human papillomavirus vaccine completion among vaccine initiators. Obstet Gynecol. 2011 Jul;118(1):14-20. doi: 10.1097/AOG.0b013e318220ebf3.
PubMed 21691158Centers for Disease Control and Prevention (CDC). National, state, and local area vaccination coverage among adolescents aged 13-17 years--United States, 2008. MMWR Morb Mortal Wkly Rep. 2009 Sep 18;58(36):997-1001.
PubMed 19763075Sankaranarayanan R, Esmy PO, Rajkumar R, Muwonge R, Swaminathan R, Shanthakumari S, Fayette JM, Cherian J. Effect of visual screening on cervical cancer incidence and mortality in Tamil Nadu, India: a cluster-randomised trial. Lancet. 2007 Aug 4;370(9585):398-406. doi: 10.1016/S0140-6736(07)61195-7.
PubMed 17679017Visual inspection with acetic acid for cervical-cancer screening: test qualities in a primary-care setting. University of Zimbabwe/JHPIEGO Cervical Cancer Project. Lancet. 1999 Mar 13;353(9156):869-73.
PubMed 10093978Belinson JL, Pretorius RG, Zhang WH, Wu LY, Qiao YL, Elson P. Cervical cancer screening by simple visual inspection after acetic acid. Obstet Gynecol. 2001 Sep;98(3):441-4. doi: 10.1016/s0029-7844(01)01454-5.
PubMed 11530126Denny L, Kuhn L, Pollack A, Wright TC Jr. Direct visual inspection for cervical cancer screening: an analysis of factors influencing test performance. Cancer. 2002 Mar 15;94(6):1699-707. doi: 10.1002/cncr.10381.
PubMed 11920531Sauvaget C, Fayette JM, Muwonge R, Wesley R, Sankaranarayanan R. Accuracy of visual inspection with acetic acid for cervical cancer screening. Int J Gynaecol Obstet. 2011 Apr;113(1):14-24. doi: 10.1016/j.ijgo.2010.10.012. Epub 2011 Jan 22.
PubMed 21257169Bosgraaf RP, Mast PP, Struik-van der Zanden PHTH, Bulten J, Massuger LFAG, Bekkers RLM. Overtreatment in a see-and-treat approach to cervical intraepithelial lesions. Obstet Gynecol. 2013 Jun;121(6):1209-1216. doi: 10.1097/AOG.0b013e318293ab22.
PubMed 23812454Klaes R, Woerner SM, Ridder R, Wentzensen N, Duerst M, Schneider A, Lotz B, Melsheimer P, von Knebel Doeberitz M. Detection of high-risk cervical intraepithelial neoplasia and cervical cancer by amplification of transcripts derived from integrated papillomavirus oncogenes. Cancer Res. 1999 Dec 15;59(24):6132-6.
PubMed 10626803Fiedler M, Muller-Holzner E, Viertler HP, Widschwendter A, Laich A, Pfister G, Spoden GA, Jansen-Durr P, Zwerschke W. High level HPV-16 E7 oncoprotein expression correlates with reduced pRb-levels in cervical biopsies. FASEB J. 2004 Jul;18(10):1120-2. doi: 10.1096/fj.03-1332fje. Epub 2004 May 20.
PubMed 15155561
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile High-Resolution Microendoscopy (mHRME) for the Detection of Cervical Dysplasia in El Salvador
- ClinicalTrials.gov ID
- NCT04472455
- Acronym / sponsor ID
- 2017-347
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,827 participants (actual)
- Lead sponsor
- William Marsh Rice UniversityUniversity, hospital or other
- Collaborators
- Basic Health International, Inc., M.D. Anderson Cancer Center, Albert Einstein College of Medicine, The Cleveland Clinic
- Study start
- Sep 2015 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 15 Jul 2020 (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.
Evaluate the performance of the mHRME in a study of 3,000 women in San Salvador to assess whether mHRME imaging improves specificity of screening by VIA or HPV DNA without reducing sensitivity for cervical precancer and cancer.
Detailed description
This is a prospective cohort study. Eligibility is open to women 30-49 years old, who are not pregnant, have an intact cervix, and no history of cervical cancer.
Visit 1:
Patients will enroll at the screening clinic of the Instituto del Cáncer de El Salvador (El Salvador Cancer Institute, ICES). An informed consent will be obtained. They will be given a urine pregnancy test; if negative, two cervical samples will be collected. The first sample will be used to screen for HPV DNA. New technologies to screen for oncoproteins and HPV will be applied to the second sample. 3-5% acetic acid will also be applied to the cervix to perform the VIA. Images of the cervix will be taken and any personally identifiable information removed.
Visit 2:
All women with a positive VIA or HPV test will undergo additional evaluation. In addition, 10% of women in the double negative group (VIA-/HPV-) will be randomly selected for evaluation. This evaluation includes: Urine pregnancy test, VIA, colposcopy, Lugol's solution application, and a HRME. 3-5% acetic acid will be applied to the cervix to perform the VIA. Proflavine and Lugol's solution (2-5%) will be applied and once again the health care provider will record their impression for each of the abnormal lesions. Cervical images will be taken. Then, 0.01% proflavine will be topically applied to the cervix for 1 minute. Images will be obtained using the mHRME system of a visually normal site and then of all lesions identified by VIA, colposcopy, and/or Lugol's solution. If no lesions are identified by VIA, colposcopy, and/or Lugol's solution, mHRME images will be taken of each quadrant. Samples of abnormal areas identified by VIA, colposcopy, Lugol's solution, and/or mHRME will be collected for biopsy and ECC purposes. If the evaluation shows no abnormalities, a random sample will be collected from the squamocolumnar junction and an ECC will be performed (only if the patient is HPV positive). Two expert pathologists will review and classify the samples. All research results will be unbeknownst to them. They will use the following classification system: normal, CIN 1, CIN 2, CIN 3, AIS, or cancer, per standard criteria. Discrepant results are resolved by a third expert pathologist, with the final result being based on 2/3 agreement. If all three pathologists arrive at different diagnoses, all three will meet in person to review to reach a consensus diagnosis. Women with CIN 2+ will undergo an excision or cryotherapy, according to the treatment standard. Patients diagnosed with invasive cancer will be referred to gynecology/oncology.
The sensitivity, specificity, positive predictive value, and negative predictive value for each screening and triage method will be compared using histopathology as the gold standard. These results will enable us to compare the total number of women that could have received adequate and inadequate treatment based on five of the most predominant clinical scenarios: VIA alone, VIA/mHRME triage, HPV test alone, HPV/VIA triage, and HPV/mHRME triage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Screen Negative Group | – | Diagnostic Test: HRMEAll women who screen negative at Visit 1. |
| Screen Positive Group | – | Diagnostic Test: HRMEAll women who screened positive at Visit 1 and were invited to Visit 2 |
| 10% Of Screen Negative Group | – | Diagnostic Test: HRME10% of women who screened negative at Visit 1 and were invited to Visit 2 |
Who may qualify
- Ages
- 30 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This is a prospective cohort study. Eligibility is open to women 30-49 years old, who are not pregn ant, have an intact cervix and no history of cervical cancer
Key inclusion criteria (5 listed)
- Women who are between the ages of 30 and 49 years of age
- All women must have a negative urine or serum pregnancy test prior to any study procedure (within 7 days)
- Intact cervix (patients who have undergone previous LEEP, cone and/ or cryotherapy are not eligible)
- No history of invasive cervical cancer
- Able and willing to provide informed consent
Key exclusion criteria (6 listed)
- Women < 30 years of age or over 49 years of age
- Women who have undergone a hysterectomy with removal of the cervix
- Women who have had a previous LEEP, Cold knife cone and/or cryotherapy
- Women who are pregnant or breastfeeding
- Women with a history of invasive cervical cancer
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 |
|---|---|---|
| HRME | Diagnostic test | 10% Of Screen Negative Group, Screen Negative Group, Screen Positive Group |
Primary outcome
Accuracy of mHRME to detect CIN2+
Time frame: 1-2 days
Calculate the sensitivity, specificity, positive predictive value, and negative predictive value of mHRME to detect CIN2+.
1 secondary outcome
Comparison of different screening and triage strategies to detect CIN2+
Time frame: 1-2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Background: PubMed 9111103Papanicolaou GN, Traut HF. The diagnostic value of vaginal smears in carcinoma of the uterus. 1941. Arch Pathol Lab Med. 1997 Mar;121(3):211-24. No abstract available.
- Background: PubMed 21296855Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
- Background: PubMed 10451482Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, Snijders PJ, Peto J, Meijer CJ, Munoz N. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999 Sep;189(1):12-9. doi: 10.1002/(SICI)1096-9896(199909)189:13.0.CO;2-F.
- Background: PubMed 17494925FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27. doi: 10.1056/NEJMoa061741.
- Background: PubMed 19586656Paavonen J, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter D, Kitchener H, Castellsague X, Teixeira JC, Skinner SR, Hedrick J, Jaisamrarn U, Limson G, Garland S, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, Jenkins D, Hardt K, Zahaf T, Descamps D, Struyf F, Lehtinen M, Dubin G; HPV PATRICIA Study Group. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet. 2009 Jul 25;374(9686):301-14. doi: 10.1016/S0140-6736(09)61248-4. Epub 2009 Jul 6.
- Background: PubMed 21691158Chou B, Krill LS, Horton BB, Barat CE, Trimble CL. Disparities in human papillomavirus vaccine completion among vaccine initiators. Obstet Gynecol. 2011 Jul;118(1):14-20. doi: 10.1097/AOG.0b013e318220ebf3.
- Background: PubMed 19763075Centers for Disease Control and Prevention (CDC). National, state, and local area vaccination coverage among adolescents aged 13-17 years--United States, 2008. MMWR Morb Mortal Wkly Rep. 2009 Sep 18;58(36):997-1001.
- Background: PubMed 17679017Sankaranarayanan R, Esmy PO, Rajkumar R, Muwonge R, Swaminathan R, Shanthakumari S, Fayette JM, Cherian J. Effect of visual screening on cervical cancer incidence and mortality in Tamil Nadu, India: a cluster-randomised trial. Lancet. 2007 Aug 4;370(9585):398-406. doi: 10.1016/S0140-6736(07)61195-7.
- Background: PubMed 10093978Visual inspection with acetic acid for cervical-cancer screening: test qualities in a primary-care setting. University of Zimbabwe/JHPIEGO Cervical Cancer Project. Lancet. 1999 Mar 13;353(9156):869-73.
- Background: PubMed 11530126Belinson JL, Pretorius RG, Zhang WH, Wu LY, Qiao YL, Elson P. Cervical cancer screening by simple visual inspection after acetic acid. Obstet Gynecol. 2001 Sep;98(3):441-4. doi: 10.1016/s0029-7844(01)01454-5.
- Background: PubMed 11920531Denny L, Kuhn L, Pollack A, Wright TC Jr. Direct visual inspection for cervical cancer screening: an analysis of factors influencing test performance. Cancer. 2002 Mar 15;94(6):1699-707. doi: 10.1002/cncr.10381.
- Background: PubMed 21257169Sauvaget C, Fayette JM, Muwonge R, Wesley R, Sankaranarayanan R. Accuracy of visual inspection with acetic acid for cervical cancer screening. Int J Gynaecol Obstet. 2011 Apr;113(1):14-24. doi: 10.1016/j.ijgo.2010.10.012. Epub 2011 Jan 22.
- Individual participant dataSharing planned: Yes. REDCap platform will be used to share data.
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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.
Mauricio Maza, MD principal investigator
Basic Health International, Inc.
Rebecca Richards-Kortum, PhD principal investigator
William Marsh Rice University
Kathleen Schmeler, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by William Marsh Rice University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Accuracy of mHRME to detect CIN2+ (time frame: 1-2 days). 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 NCT04472455, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.