Pneumonia, InterstitialNCT04734067
Exploration of the Predictive Marker and Establishment of Predictive Models of Checkpoint Inhibitor Pneumonitis
An observational study of Pneumonia, Interstitial, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
This is a prospective, multicenter observational study to explore the predictive factors of checkpoint inhibitor pneumonitis (CIP) and to establish predictive models by combining imaging information for IRP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Interstitial
- What is being tested?
- Immune checkpoint inhibitors(ICIs) therapy
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2021to 1 Feb 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with malignant tumor receiving immune checkpoint inhibitors for the first time.
Who may be able to join
- age ≥ 18 years;
- Obtain written informed consent and any locally required authorization from the patient or his/her legal representative prior to the commencement of any study protocol related procedures, including screening assessments;
- Patients with malignant tumors confirmed by histology or cytology can be treated with ICIs after evaluation by a professional oncologist, with no restriction on cancer type or stage;
- Life expectancy on day 1 ≥12 weeks;
- When selected, the Eastern Cooperative Oncology Group (ECOG) physical status score was 0-2;
- No previous use of immunotherapy；
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- No prior exposure to immune-mediated therapy;
- Have sufficient viscera function and bone marrow function;
- Evidence of postmenopausal status in women, or negative urine or serum pregnancy tests in premenopausal women.
Who cannot join
- The target lesion had received immune-related treatment or immune-mediated treatment before;
- Patients with clinically confirmed moderate to severe pulmonary interstitial fibrosis before taking ICIs;
- Major surgical procedures were performed within 28 days of the first medication;
- History of allograft transplantation;
- Active or previously documented autoimmune or inflammatory diseases or other contraindications for immunotherapy;
- Uncontrolled serious complications such as infection and acute cardio-cerebrovascular disease;
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- The presence of another primary malignancy;
- anaphylaxis or hypersensitivity to immunotherapy or chemotherapy;
- Decompensation of viscera and low bone marrow function and hematopoietic function；
- Pregnant or lactating female patients;
- Expected survival time < 3 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Exploration of Predictive Markers and Establishment of Predictive Models for Checkpoint Inhibitor Pneumonitis in Combination With Imaging in Immune Checkpoint Inhibitor Therapy
This is a prospective, multicenter observational study to explore the predictive factors of checkpoint inhibitor pneumonitis (CIP) and to establish predictive models by combining imaging information for IRP. The imaging type of CIP, the pathological type, various inflammatory cytokines and tumor proportion score(TPS) of PD-L1 expression level, etc. will be paid more attention.
Read the detailed description
Prospective dual-arm, multicenter observational study to explore the predictive factors of checkpoint inhibitor pneumonitis (CIP) and to establish predictive models by combining imaging information.Patients will receive work-up, treatment and follow-up exclusively as routinely done except monitoring and evaluation of CIP. Necessary tests will be required, such as lung function tests, lymphocyte subsets, and thin-section CT of the chest during evaluation of the disease.This study mainly included patients with malignant tumor who received immune checkpoint inhibitors for the first time.Fasting venous blood was taken before treatment and before cycle 3,5...2n+1 of treatment. Then the blood samples were centrifuged and frozen in a refrigerator at -80℃ for later mass spectrometry analysis. IrAEs of patients was strictly recorded according to CommonTerminology Criteria Adverse Events V4.0 (CTCAE V4.0). The main objective was to explore the relationship between various indicators and the occurrence of CIP, including pulmonary ventilation and diffusion function at baseline, C-reative protein(CRP), cytokines, interleukin-6(IL-6), CD4+ T lymphocyte count and percentage, CD8+ T lymphocyte count and percentage, NK cell count and percentage, total T lymphocyte count and percentage, neutrophil counts and percentages, eosinophilic cell count and percentage, white blood cell count, blood platelet count, serum albumin(ALB), alanine aminotransferase(ALT), aspartate aminotransferase (AST), γ-glutamyl transpeptadase（γ-GGT), body mass index (BMI), serum procalcitonin(PCT), smoking index and various inflammatory cytokines.
Primary study endpoints: The predictive factors and the predictive models of CIP.
Secondary study endpoints: The incidence and clinical characteristics of CIP.
- Conditions
- Pneumonia, Interstitial
- Being tested
- Immune checkpoint inhibitors(ICIs) therapy
- Keywords
- immune checkpoint inhibitors, predictive marker, predictive model, immunotherapy
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune checkpoint inhibitors(ICIs) therapyOther
Patients with malignant tumors who first received ICIs
| Study group | Role | What they receive |
|---|---|---|
| observational group | Patients receiving ICIs for the first time Receives: Other: Immune checkpoint inhibitors(ICIs) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of C reactive protein(CRP); mg/L
CRP level in the serum.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Interleukin-6(IL-6); Pg/ml
IL-6 level in the serum.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
CD4+ T lymphocyte; /uL
The absolute and relative counts of CD4+ T lymphocyte in whole blood.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
CD4+ T lymphocyte; percent
Percentage of CD4+ T lymphocyte in whole blood.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
CD8+ T lymphocyte; /uL
The absolute and relative counts of CD8+ T lymphocyte in whole blood.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
CD8+ T lymphocyte; percent
Percentage of CD8+ T lymphocyte in whole blood.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
NK cell; /uL
The absolute and relative counts of NK cell in whole blood.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
NK cell; percent
Percentage of NK cell in whole blood.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
White blood cell count; 10^9/L
The white blood cell count in whole blood.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Lymphocyte count; 10^9/L
The absolute and relative counts of total lymphocyte count in whole blood.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Lymphocyte count; percent
Percentage of total lymphocyte count in whole blood.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Eosinophils count; 10^9/L
The absolute and relative counts of eosinophils count in whole blood.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Eosinophils count; percent
Percentage of eosinophils count in whole blood.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Blood platelet count; 10^9/L
The blood platelet count in whole blood.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Alanine aminotransferase(ALT); U/L
The ALT level in the serum.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Aspartate aminotransferase (AST); U/L
The AST level in the serum.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Serum albumin; g/L
The albumin level in the serum.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
γ-glutamyl transpeptadase（γ-GGT); U/L
The γ-GGT level in the serum.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Smoking index
The average root number per day multiplied by smoking years of smoking, that is, smoking index.
Measured: At baseline
Body mass index (BMI); kg/m^2
The body's weight(Kg) divided by the square of your height(m), that is, body mass index.
Measured: At baseline
Serum procalcitonin(PCT); ng/ml
The PCT level in the serum.
Measured: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Forced vital capacity(FVC); L
The maximum amount of air that can be exhaled as soon as possible after the maximum inhalation. FVC was used to evaluate pulmonary ventilation function.
Measured: Before Cycle 1.
Forced the first second of expiratory volume (FEV1); L
the first second of exhalation during the maximum exhalation after the maximum deep inhalation. FEV1 was used to evaluate pulmonary ventilation function.
Measured: Before Cycle 1.
FEV1/FVC; percent
FEV1 accounts for the percentage of FVC. FEV1/FVC was used to evaluate pulmonary ventilation function.
Measured: Before Cycle 1.
Maximal mid-expiratory flow(MMEF); L/s
The average flow rate with forced exhalation of 25% to 75% of lung capacity. FEV1/FVC was used to evaluate pulmonary ventilation function.
Measured: Before Cycle 1.
Fractional exhaled nitric oxide (FeNO) measurement；ppb
FeNO measurement quantified the amount of nitric oxide (NO) in one's exhaled breath, which was used to evaluate pulmonary diffusion function.
Measured: Before Cycle 1.
Secondary outcomes (1)
The incidence of IRP; percent
The incidence of IRP in the general population receiving ICIs
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start20 Aug 2021 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, InterstitialStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- 440 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tang-Du Hospital, The First Affiliated Hospital of Zhengzhou University, Henan Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Fujian Cancer Hospital
- Responsible party
- Sponsor
- Investigators
- Hui Guo, PH.D, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734067
- Sponsor's protocol ID
- XJTU1AF2021LSK-001
- Status last verified
- Aug 2021
- First submitted
- 12 Jan 2021
- Last updated
- 23 Aug 2021
- 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 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Predictive Markers and Establishment of Predictive Models for Checkpoint Inhibitor Pneumonitis in Combination With Imaging in Immune Checkpoint Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT04734067
- Acronym / sponsor ID
- XJTU1AF2021LSK-001
- Conditions
- Pneumonia, Interstitial
- Keywords
- immune checkpoint inhibitors, predictive marker, predictive model, immunotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Tang-Du Hospital, The First Affiliated Hospital of Zhengzhou University, Henan Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Fujian Cancer Hospital
- Study start
- 20 Aug 2021 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 2 Feb 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.
This is a prospective, multicenter observational study to explore the predictive factors of checkpoint inhibitor pneumonitis (CIP) and to establish predictive models by combining imaging information for IRP. The imaging type of CIP, the pathological type, various inflammatory cytokines and tumor proportion score(TPS) of PD-L1 expression level, etc. will be paid more attention.
Detailed description
Prospective dual-arm, multicenter observational study to explore the predictive factors of checkpoint inhibitor pneumonitis (CIP) and to establish predictive models by combining imaging information.Patients will receive work-up, treatment and follow-up exclusively as routinely done except monitoring and evaluation of CIP. Necessary tests will be required, such as lung function tests, lymphocyte subsets, and thin-section CT of the chest during evaluation of the disease.This study mainly included patients with malignant tumor who received immune checkpoint inhibitors for the first time.Fasting venous blood was taken before treatment and before cycle 3,5...2n+1 of treatment. Then the blood samples were centrifuged and frozen in a refrigerator at -80℃ for later mass spectrometry analysis. IrAEs of patients was strictly recorded according to CommonTerminology Criteria Adverse Events V4.0 (CTCAE V4.0). The main objective was to explore the relationship between various indicators and the occurrence of CIP, including pulmonary ventilation and diffusion function at baseline, C-reative protein(CRP), cytokines, interleukin-6(IL-6), CD4+ T lymphocyte count and percentage, CD8+ T lymphocyte count and percentage, NK cell count and percentage, total T lymphocyte count and percentage, neutrophil counts and percentages, eosinophilic cell count and percentage, white blood cell count, blood platelet count, serum albumin(ALB), alanine aminotransferase(ALT), aspartate aminotransferase (AST), γ-glutamyl transpeptadase（γ-GGT), body mass index (BMI), serum procalcitonin(PCT), smoking index and various inflammatory cytokines.
Primary study endpoints: The predictive factors and the predictive models of CIP.
Secondary study endpoints: The incidence and clinical characteristics of CIP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational group | – | Other: Immune checkpoint inhibitors(ICIs) therapyPatients receiving ICIs for the first time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with malignant tumor receiving immune checkpoint inhibitors for the first time.
Key inclusion criteria (9 listed)
- age ≥ 18 years;
- Obtain written informed consent and any locally required authorization from the patient or his/her legal representative prior to the commencement of any study protocol related procedures, including screening assessments;
- Patients with malignant tumors confirmed by histology or cytology can be treated with ICIs after evaluation by a professional oncologist, with no restriction on cancer type or stage;
- Life expectancy on day 1 ≥12 weeks;
- When selected, the Eastern Cooperative Oncology Group (ECOG) physical status score was 0-2;
Key exclusion criteria (11 listed)
- The target lesion had received immune-related treatment or immune-mediated treatment before;
- Patients with clinically confirmed moderate to severe pulmonary interstitial fibrosis before taking ICIs;
- Major surgical procedures were performed within 28 days of the first medication;
- History of allograft transplantation;
- Active or previously documented autoimmune or inflammatory diseases or other contraindications for immunotherapy;
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 |
|---|---|---|
| Immune checkpoint inhibitors(ICIs) therapyPatients with malignant tumors who first received ICIs | Other | observational group |
Primary outcome
The change of C reactive protein(CRP); mg/L
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
CRP level in the serum.
Interleukin-6(IL-6); Pg/ml
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
IL-6 level in the serum.
CD4+ T lymphocyte; /uL
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
The absolute and relative counts of CD4+ T lymphocyte in whole blood.
CD4+ T lymphocyte; percent
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Percentage of CD4+ T lymphocyte in whole blood.
CD8+ T lymphocyte; /uL
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
The absolute and relative counts of CD8+ T lymphocyte in whole blood.
CD8+ T lymphocyte; percent
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Percentage of CD8+ T lymphocyte in whole blood.
NK cell; /uL
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
The absolute and relative counts of NK cell in whole blood.
NK cell; percent
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Percentage of NK cell in whole blood.
White blood cell count; 10^9/L
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
The white blood cell count in whole blood.
Lymphocyte count; 10^9/L
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
The absolute and relative counts of total lymphocyte count in whole blood.
Lymphocyte count; percent
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Percentage of total lymphocyte count in whole blood.
Eosinophils count; 10^9/L
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
The absolute and relative counts of eosinophils count in whole blood.
Eosinophils count; percent
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Percentage of eosinophils count in whole blood.
Blood platelet count; 10^9/L
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
The blood platelet count in whole blood.
Alanine aminotransferase(ALT); U/L
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
The ALT level in the serum.
Aspartate aminotransferase (AST); U/L
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
The AST level in the serum.
Serum albumin; g/L
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
The albumin level in the serum.
γ-glutamyl transpeptadase（γ-GGT); U/L
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
The γ-GGT level in the serum.
Smoking index
Time frame: At baseline
The average root number per day multiplied by smoking years of smoking, that is, smoking index.
Body mass index (BMI); kg/m^2
Time frame: At baseline
The body's weight(Kg) divided by the square of your height(m), that is, body mass index.
Serum procalcitonin(PCT); ng/ml
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
The PCT level in the serum.
Forced vital capacity(FVC); L
Time frame: Before Cycle 1.
The maximum amount of air that can be exhaled as soon as possible after the maximum inhalation. FVC was used to evaluate pulmonary ventilation function.
Forced the first second of expiratory volume (FEV1); L
Time frame: Before Cycle 1.
the first second of exhalation during the maximum exhalation after the maximum deep inhalation. FEV1 was used to evaluate pulmonary ventilation function.
FEV1/FVC; percent
Time frame: Before Cycle 1.
FEV1 accounts for the percentage of FVC. FEV1/FVC was used to evaluate pulmonary ventilation function.
Maximal mid-expiratory flow(MMEF); L/s
Time frame: Before Cycle 1.
The average flow rate with forced exhalation of 25% to 75% of lung capacity. FEV1/FVC was used to evaluate pulmonary ventilation function.
Fractional exhaled nitric oxide (FeNO) measurement；ppb
Time frame: Before Cycle 1.
FeNO measurement quantified the amount of nitric oxide (NO) in one's exhaled breath, which was used to evaluate pulmonary diffusion function.
1 secondary outcome
The incidence of IRP; percent
Time frame: Up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- 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.
Hui Guo, PH.D principal investigator
First Affiliated Hospital Xi'an Jiaotong University
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Interstitial, run by First Affiliated Hospital Xi'an Jiaotong 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 9 inclusion and 11 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 23 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Guo, PH.D (0086-13572824106, guohuihappy97@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of C reactive protein(CRP); mg/L (time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.). The study lists 26 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 23 Aug 2021.