Neurologic DisorderFulgurnanoNCT04380194
Intracorporeal Nanocomposites and Neurological Disorders in Fulgurates (FulgurnanoF)
An observational study of Neurologic Disorder, run by University Hospital, Clermont-Ferrand at 5 sites in France.
Trial summary
Objective: To demonstrate the presence of bioresistant intracorporeal carbon-based nanocomposites in subjects exposed to a fulguration, in the immediate aftermath of this fulguration and 24 months (+/- 6 months) after the accident, on blood and urine samples, then in comparison with blood and urine samples from 14… Read more about this study
- Who is it for?
- Ages 7 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurologic Disorder
- What is being tested?
- nano-composite screening
- How many people
- 27 participants
- Where
- 5 sitesFrance
- Study dates
- 20 May 2019to 10 Sep 2020
- 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 7 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients affected by lightning in collective fulguration and healthy witnesses who have never been in contact with lightning, matched on age and sex
Who may be able to join
- -Patients exposed: all subjects who were victims of the fulguration accident.
- Non-exposed patients:
- 14 subjects,
- of all ages,
- free of major pathology and having never been the victim of a fulguration accident, nor having witnessed a fulguration at less than 20 meters,
- having never worked in a high-energy environment (CEA, EDF, particle accelerator, AREVA-type laboratory, radiology manipulator, radiation protection profession).
Who cannot join
- Pregnant or breastfeeding woman.
- Subject under guardianship, curatorship or safeguard of justice, or deprived of liberties.
- Any condition judged by the investigator to be incompatible with the research.
- Refusal to participate. Exposed patients: if the above-mentioned accident induced more than a simple lightning strike (lightning: died by lightning, electrocution: touched by an electric current, electrocution: died by contact with an electric current).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CH Henri Mondor
Aurillac
CH de Luneville
Lunéville
CHRU Bradois
Nancy
CHRU de Nancy
Nancy
CH de SAINT-DIE-DES-VOSGES
Saint-Dié
About this study
Official title: Detection of Intracorporeal Bioresistant Nanocomposites Tracing Short- and Long-term Neurological Disorders in a Collective Fulguration
Objective: To demonstrate the presence of bioresistant intracorporeal carbon-based nanocomposites in subjects exposed to a fulguration, in the immediate aftermath of this fulguration and 24 months (+/- 6 months) after the accident, on blood and urine samples, then in comparison with blood and urine samples from 14 healthy subjects.
Hypothesis: Lightning discharge in the human body reveals the presence of multi-functional nanoparticles which are reassembled under the impact of the electric discharge into nanostructured films, filaments and aggregates; they consist of dispersed graphene-like nanoparticles embedded in an aliphatic cross-reticulated matrix. The high electrical conductivity of the nanoinclusions, their refractory properties and the cross-reticulation of the nanoassemblages explain their biorésistance.
The graphene-like multi-functional nanoparticles are assumed to trace a population of aerosols formed in the atmosphere by plasma discharge which is present in air, water and all natural resources. Their ability to undergo changes from folded nanosheets to confined ultra-fine nanoparticles allow them to be inhaled or absorbed by the human body, or to be ingested with food.
Read the detailed description
In order to detect nanocomposites in patients who have been impacted by lightning, an analysis protocol will be performed on the remains of blood and urine samples from their initial medical admission. After filtering the blood and urine samples, the remaining nanocomposites are selected for characterization, at micro to nanoscale, using the scanning electron microscope and the transmission electron microscope.
Based on laboratory experiments, a second sampling of blood and urine will be performed 24 months (+/-6 months) after the lightning strike to follow the delayed production of nanocomposites from the remaining activated nanoparticles.
- Presence of bioresistant nanocomposites in blood and urine at D0 and M24 (+/- 6 months) :
- If the victim was treated between H0 and H2 after the fulguration : an initial blood sample was taken by the SMUR or the emergency room and stored
- If the victim was treated between H0 and H6: urine sample was taken from the first urine after fulguration.
- At M24 (+/- 6 months) after the fulguration: collection of 18 ml of blood and two bottles of urine.
In order to describe the neurological disorders of the patients, initial clinical, biological and radiological data will be collected in the patients' medical records and a new clinical examination will be performed at 24 months (+/- 6 months) after fulguration.
-Search for descriptive data.
- testimonials Data collected:
- During the interrogation of the patient on the day of the fulguration
- In the medical file of the patient consulted at the department's administration
- During the interview organized at 24 months (+/- 6 months) after the fulguration
- Entry in the observation logbook (RedCap)
- clinics Data collected :
- From the day of the fulguration, in the medical file of the patient consulted at the department's administration
- During the interview organized at 24 months (+/- 6 months) from the fulguration where a clinical examination will be carried out.
- Entry in the observation notebook (RedCap)
- organic Data collected :
- In the medical record of the patient at the time of the fulguration consulted at the department's administration
- from biological samples taken 24 months (+/- 6 months) after fulguration
- Entry in the observation logbook (RedCap)
- imagery Data collected :
- In the medical file of the patient consulted at the department's administration
- Entry in the observation logbook (RedCap)
- Presence and description of neurological disorders in exposed patients, immediately after the event and M24 (+/- 6 months) after the accident. H0 will be the time when the accident took place. H0-H12: Collection of clinical, biological and radiological information in the patient's medical record. Recovery at M24 (+/- 6 months) for immediate or prolonged initial neurological disorders. At M24 (+/- 6 months): medical examination at the patient's home to :
- hear their testimony
- describe the delayed neurological disorders This interview will be based on the Toulouse fulgurate questionnaire.
- Description of the treatments administered to the exposed patients during the 2 years following the accident (medication, physiotherapy, rehabilitation, work stoppage).
- Depending on their complaints, patients will be taken care of by various health professionals (general practitioner, physician, pharmacist, physiotherapist, occupational therapist, speech therapist) who will prescribe various types of care (medication, leave from work, physiotherapy, rehabilitation).
- At M24 (+/- 6 months), after questioning the patient and his doctor, the care received will be traced (qualitative and quantitative).
- Descriptions of the effects of the treatments administered during the 2 years following the accident. At M24 (+/- 6 months): Description of the evolution of neurological disorders in time, recovery quality and location.
- Presence and description of other organic lesions.
- The objective is to know what other internal organs may have been affected by the lightning strike
- Looking through the medical file for the clinical examination of J0 and those of follow-ups
- Looking through the biological assessment carried out immediately after the event between H0 and H12 in the lighting-stroke patient to highlight which organs were affected (bloodlines, kidney, liver, muscle, heart).
- Basic biology screening to look for the following information:
- NFS / Platelet / VS / Coagulation check-up
- Blood ionogram (Na+ Cl- K+ Total Ca ionized Ca Mg++ HCO3- HPO4--)
- Blood creatinine / urea / CPK / LDH
- Troponin in cycle
- Liver check-up
- CRP Description of measures taken to reduce and avoid bias Measurement bias:
- Preliminary experiments carried out by the CNRS team with a lightning reactor on self-samples of urine in order to obtain comparative images, adapt the manipulations and anticipate the preparation of the lighting-stroke patient samples to select the most representative nanocomposites for high resolution microscopic characterization.
- During the analysis of the samples, the only two experimenters will be the investigator coordinating the study, Dr FOUSSAT, and Dr COURTY. There will be a double reading of each sample with consultation on the description.
- Photos will be taken with the same camera. Selection bias:
- None, because all 14 patients were fulgurated. Memory bias:
- Cross-check the patients' testimonies with the analyses and complementary examinations carried out, requested by the attending physician or another health professional. Sampling bias:
- Matching the 14 healthy subjects to the age and sex of the 14 fulgurated subjects. In order to better understand the mechanisms of in vivo formation of these nanocomposites, an attempt will be made to identify them in healthy subjects. -Qualitative and quantitative aspects of bioremediation nanocomposites possibly identified in the blood of subjects not affected by lightning-strike. Analysis of the blood of 14 healthy patients for:
- controlling stochastic forming mechanisms of polymer nanocomposite;
- controlling effects of environmental factors (air and water quality) on the abundance and properties of airmade polymer nanocomposites
- proof-of-concept justification
- full analytical procedure. Low levels of bioresistant nanocomposites are expected in this group. The aim is to trace the occurrence of nanocomposites formed by plasma discharges in the atmosphere which have passed through the alveolar and digestive barrier into the bloodstream. The blood of healthy subjects will be collected at the Aurillac CH laboratory by taking an additional 18 ml on sodium heparinate tube during a blood test for routine check-up (INR monitoring for example). Patients will be given an information note and a consent form stating that they accept this additional volume of sample. They will inform their work and their commune of residence. The samples will be anonymised and packaged for transport to the Aurillac laboratory for analysis under a stereomicroscope microscope in the alcoholic liquid phase. They will then be sent in dry form to the CNRS for analysis by scanning and transmission electron microscope.
- Conditions
- Neurologic Disorder
- Being tested
- nano-composite screening
- Keywords
- neurologic disorders, Keraunopathology, neuropsychological disorders, bioresistant nanocomposite, collective lightning-strike injuries
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nano-composite screeningDiagnostic test
Recovery of the bottoms of the victims' blood and urine tubes at H+4. Blood and urine samples from the victims at two years of age. Single blood and urine samples from the witnesses
| Study group | Role | What they receive |
|---|---|---|
| victims | thirteen patients affected by lightning in collective fulguration Receives: Diagnostic Test: nano-composite screening | |
| healthy witnesses | fourteen healthy witnesses who have never been in contact with lightning, matched on age and sex Receives: Diagnostic Test: nano-composite screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of bioresistant nanocomposites
Characterization in blood
Measured: Day 0
Description of bioresistant nanocomposites
Characterization in blood
Measured: Month 24
Description of bioresistant nanocomposites
Characterization in urine
Measured: Hour 12
Description of bioresistant nanocomposites
Characterization in urine
Measured: Month 24
Secondary outcomes (4)
neurological disorders
Research and description of neurological disorders with questioning of date of onset and duration
Measured: Day 0
neurological disorders
Research and description of neurological disorders with questioning of date of onset and duration
Measured: Month 24
neuropsychological disorders
Research and description of neuropsychological disorders with questioning of date of onset and duration
Measured: Day 0
neuropsychological disorders
Research and description of neuropsychological disorders with questioning of date of onset and duration
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start20 May 2019
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- PROMES UPR 8521 DR2-CNRS, LPC UMR 6533, Campus Universitaire des Cézeaux
- Responsible party
- Sponsor
- Investigators
- Laurent Caumon, Principal investigator, CH Henri Mondor (Aurillac)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380194
- Sponsor's protocol ID
- RBHP 2018 CAUMONT
- Other IDs
- 2018-A01725-50
- Acronym
- Fulgurnano
- Status last verified
- Sep 2020
- First submitted
- 5 May 2020
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Intracorporeal Bioresistant Nanocomposites Tracing Short- and Long-term Neurological Disorders in a Collective Fulguration
- ClinicalTrials.gov ID
- NCT04380194
- Acronym / sponsor ID
- Fulgurnano / RBHP 2018 CAUMONT
- Conditions
- Neurologic Disorder
- Keywords
- neurologic disorders, Keraunopathology, neuropsychological disorders, bioresistant nanocomposite, collective lightning-strike injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- PROMES UPR 8521 DR2-CNRS, LPC UMR 6533, Campus Universitaire des Cézeaux
- Study start
- 20 May 2019 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 8 May 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.
Objective: To demonstrate the presence of bioresistant intracorporeal carbon-based nanocomposites in subjects exposed to a fulguration, in the immediate aftermath of this fulguration and 24 months (+/- 6 months) after the accident, on blood and urine samples, then in comparison with blood and urine samples from 14 healthy subjects.
Hypothesis: Lightning discharge in the human body reveals the presence of multi-functional nanoparticles which are reassembled under the impact of the electric discharge into nanostructured films, filaments and aggregates; they consist of dispersed graphene-like nanoparticles embedded in an aliphatic cross-reticulated matrix. The high electrical conductivity of the nanoinclusions, their refractory properties and the cross-reticulation of the nanoassemblages explain their biorésistance.
The graphene-like multi-functional nanoparticles are assumed to trace a population of aerosols formed in the atmosphere by plasma discharge which is present in air, water and all natural resources. Their ability to undergo changes from folded nanosheets to confined ultra-fine nanoparticles allow them to be inhaled or absorbed by the human body, or to be ingested with food.
Detailed description
In order to detect nanocomposites in patients who have been impacted by lightning, an analysis protocol will be performed on the remains of blood and urine samples from their initial medical admission. After filtering the blood and urine samples, the remaining nanocomposites are selected for characterization, at micro to nanoscale, using the scanning electron microscope and the transmission electron microscope.
Based on laboratory experiments, a second sampling of blood and urine will be performed 24 months (+/-6 months) after the lightning strike to follow the delayed production of nanocomposites from the remaining activated nanoparticles.
- Presence of bioresistant nanocomposites in blood and urine at D0 and M24 (+/- 6 months) :
- If the victim was treated between H0 and H2 after the fulguration : an initial blood sample was taken by the SMUR or the emergency room and stored
- If the victim was treated between H0 and H6: urine sample was taken from the first urine after fulguration.
- At M24 (+/- 6 months) after the fulguration: collection of 18 ml of blood and two bottles of urine.
In order to describe the neurological disorders of the patients, initial clinical, biological and radiological data will be collected in the patients' medical records and a new clinical examination will be performed at 24 months (+/- 6 months) after fulguration.
-Search for descriptive data.
- testimonials Data collected:
- During the interrogation of the patient on the day of the fulguration
- In the medical file of the patient consulted at the department's administration
- During the interview organized at 24 months (+/- 6 months) after the fulguration
- Entry in the observation logbook (RedCap)
- clinics Data collected :
- From the day of the fulguration, in the medical file of the patient consulted at the department's administration
- During the interview organized at 24 months (+/- 6 months) from the fulguration where a clinical examination will be carried out.
- Entry in the observation notebook (RedCap)
- organic Data collected :
- In the medical record of the patient at the time of the fulguration consulted at the department's administration
- from biological samples taken 24 months (+/- 6 months) after fulguration
- Entry in the observation logbook (RedCap)
- imagery Data collected :
- In the medical file of the patient consulted at the department's administration
- Entry in the observation logbook (RedCap)
- Presence and description of neurological disorders in exposed patients, immediately after the event and M24 (+/- 6 months) after the accident. H0 will be the time when the accident took place. H0-H12: Collection of clinical, biological and radiological information in the patient's medical record. Recovery at M24 (+/- 6 months) for immediate or prolonged initial neurological disorders. At M24 (+/- 6 months): medical examination at the patient's home to :
- hear their testimony
- describe the delayed neurological disorders This interview will be based on the Toulouse fulgurate questionnaire.
- Description of the treatments administered to the exposed patients during the 2 years following the accident (medication, physiotherapy, rehabilitation, work stoppage).
- Depending on their complaints, patients will be taken care of by various health professionals (general practitioner, physician, pharmacist, physiotherapist, occupational therapist, speech therapist) who will prescribe various types of care (medication, leave from work, physiotherapy, rehabilitation).
- At M24 (+/- 6 months), after questioning the patient and his doctor, the care received will be traced (qualitative and quantitative).
- Descriptions of the effects of the treatments administered during the 2 years following the accident. At M24 (+/- 6 months): Description of the evolution of neurological disorders in time, recovery quality and location.
- Presence and description of other organic lesions.
- The objective is to know what other internal organs may have been affected by the lightning strike
- Looking through the medical file for the clinical examination of J0 and those of follow-ups
- Looking through the biological assessment carried out immediately after the event between H0 and H12 in the lighting-stroke patient to highlight which organs were affected (bloodlines, kidney, liver, muscle, heart).
- Basic biology screening to look for the following information:
- NFS / Platelet / VS / Coagulation check-up
- Blood ionogram (Na+ Cl- K+ Total Ca ionized Ca Mg++ HCO3- HPO4--)
- Blood creatinine / urea / CPK / LDH
- Troponin in cycle
- Liver check-up
- CRP Description of measures taken to reduce and avoid bias Measurement bias:
- Preliminary experiments carried out by the CNRS team with a lightning reactor on self-samples of urine in order to obtain comparative images, adapt the manipulations and anticipate the preparation of the lighting-stroke patient samples to select the most representative nanocomposites for high resolution microscopic characterization.
- During the analysis of the samples, the only two experimenters will be the investigator coordinating the study, Dr FOUSSAT, and Dr COURTY. There will be a double reading of each sample with consultation on the description.
- Photos will be taken with the same camera. Selection bias:
- None, because all 14 patients were fulgurated. Memory bias:
- Cross-check the patients' testimonies with the analyses and complementary examinations carried out, requested by the attending physician or another health professional. Sampling bias:
- Matching the 14 healthy subjects to the age and sex of the 14 fulgurated subjects. In order to better understand the mechanisms of in vivo formation of these nanocomposites, an attempt will be made to identify them in healthy subjects. -Qualitative and quantitative aspects of bioremediation nanocomposites possibly identified in the blood of subjects not affected by lightning-strike. Analysis of the blood of 14 healthy patients for:
- controlling stochastic forming mechanisms of polymer nanocomposite;
- controlling effects of environmental factors (air and water quality) on the abundance and properties of airmade polymer nanocomposites
- proof-of-concept justification
- full analytical procedure. Low levels of bioresistant nanocomposites are expected in this group. The aim is to trace the occurrence of nanocomposites formed by plasma discharges in the atmosphere which have passed through the alveolar and digestive barrier into the bloodstream. The blood of healthy subjects will be collected at the Aurillac CH laboratory by taking an additional 18 ml on sodium heparinate tube during a blood test for routine check-up (INR monitoring for example). Patients will be given an information note and a consent form stating that they accept this additional volume of sample. They will inform their work and their commune of residence. The samples will be anonymised and packaged for transport to the Aurillac laboratory for analysis under a stereomicroscope microscope in the alcoholic liquid phase. They will then be sent in dry form to the CNRS for analysis by scanning and transmission electron microscope.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| victims | – | Diagnostic Test: nano-composite screeningthirteen patients affected by lightning in collective fulguration |
| healthy witnesses | – | Diagnostic Test: nano-composite screeningfourteen healthy witnesses who have never been in contact with lightning, matched on age and sex |
Who may qualify
- Ages
- 7 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients affected by lightning in collective fulguration and healthy witnesses who have never been in contact with lightning, matched on age and sex
Key inclusion criteria (6 listed)
- -Patients exposed: all subjects who were victims of the fulguration accident.
- 14 subjects,
- of all ages,
- free of major pathology and having never been the victim of a fulguration accident, nor having witnessed a fulguration at less than 20 meters,
- having never worked in a high-energy environment (CEA, EDF, particle accelerator, AREVA-type laboratory, radiology manipulator, radiation protection profession).
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding woman.
- Subject under guardianship, curatorship or safeguard of justice, or deprived of liberties.
- Any condition judged by the investigator to be incompatible with the research.
- Refusal to participate. Exposed patients: if the above-mentioned accident induced more than a simple lightning strike (lightning: died by lightning, electrocution: touched by an electric current, electrocution: died by contact with an electric current).
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 |
|---|---|---|
| nano-composite screeningRecovery of the bottoms of the victims' blood and urine tubes at H+4. Blood and urine samples from the victims at two years of age. Single blood and urine samples from the witnesses | Diagnostic test | healthy witnesses, victims |
Primary outcome
Description of bioresistant nanocomposites
Time frame: Day 0
Characterization in blood
Description of bioresistant nanocomposites
Time frame: Month 24
Characterization in blood
Description of bioresistant nanocomposites
Time frame: Hour 12
Characterization in urine
Description of bioresistant nanocomposites
Time frame: Month 24
Characterization in urine
4 secondary outcomes
neurological disorders
Time frame: Day 0
neurological disorders
Time frame: Month 24
neuropsychological disorders
Time frame: Day 0
neuropsychological disorders
Time frame: Month 24
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 11 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Laurent Caumon principal investigator
CH Henri Mondor (Aurillac)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurologic Disorder, run by University Hospital, Clermont-Ferrand at 5 sites in France.
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 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of bioresistant nanocomposites (time frame: Day 0). The study lists 4 primary outcomes in all. 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 2020.