Extensive-stage Small-cell Lung CancerNCT04947774
Prophylactic Cranial Irradiation in Extensive-stage Small Cell Lung Cancer
An observational study of Extensive-stage Small-cell Lung Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The prognosis of extensive-stage small cell lung cancer is still very poor, even for those who received chemotherapy and immunotherapy. This experimental study is a real-world research design to evaluate the effectiveness and safety of prophylactic cranial irradiation in patients with extensive-stage small cell lung… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small-cell Lung Cancer
- What is being tested?
- Prophylactic Cranial Irradiation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to Oct 2022
- 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: It is planned to enroll patients who have completed and response to first-line chemotherapy combined with immunotherapy, Later immunotherapy treatments are open
Who may be able to join
- Sign written informed consent;
- With extensive small cell lung cancer;
- Previously received first-line standard chemotherapy, with treatment response of CR or PR;
- Can tolerate the radiotherapy process;
- Be over 18 years old
- Life expectancy ≥ 12 weeks;
- With the Eastern Cancer Cooperative Group (ECOG) score 0-1
- After the systemic treatment was received, there was no brain metastasis on MR before brain preventive irradiation.
Who cannot join
- Exclude subjects with central nervous system (CNS) metastasis at the first diagnosis;
- Pregnancy or breastfeeding;
- Any other conclusive medical, psychiatric and/or social reasons determined by the researcher;
- Subjects who have previously suffered from other malignant tumors (excluding non-melanoma skin cancer and the following carcinoma in situ: bladder, stomach, colon, endometrial, cervical/dysplasia, melanoma or breast cancer) are not allowed to participate in the study. Unless he/she has been in complete remission at least 2 years before enrolling in the study, and does not need to receive other treatments or does not need to receive other treatments during the study;
- Researchers believe that the treatment methods used in the study can cause harm or cause basic diseases whose toxicity is difficult to judge when judging adverse events.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
wang Luhua, MD
Wang Luhua, MD
About this study
Official title: Real-world Study of Prophylactic Cranial Irradiation After Immunotherapy Combined With Chemotherapy for Extensive-stage Small Cell Lung Cancer
The prognosis of extensive-stage small cell lung cancer is still very poor, even for those who received chemotherapy and immunotherapy. This experimental study is a real-world research design to evaluate the effectiveness and safety of prophylactic cranial irradiation in patients with extensive-stage small cell lung cancer who with first-line chemotherapy combined with immunotherapy.
Read the detailed description
This study is a prospective trial. This study included ES-SCLC patients who response after standard first-line treatment, and aimed to explore the safety and effectiveness of prophylactic cranial irradiation in this treatment modality.
The primary endpoint is progression-free survival in the brain.The secondary endpoints includes OS, PFS. The indicators for evaluating safety are the incidence and severity of adverse events.The exploratory endpoint is the molecular biomarkers for efficacy and toxicity predicting from tumor tissue and peripheral blood TMB.
The trial was designed by the National Cancer Center/Cancer Hospital of the Chinese Academy of Medical Sciences and Peking Union Medical College. The hypothesis is that preventive brain irradiation is safe and effective in the treatment of extensive SCLC combined with chemotherapy and immunotherapy.
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Being tested
- Prophylactic Cranial Irradiation
- Keywords
- Small-cell Lung Cancer, Radiation:prophylactic cranial irradiation
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic Cranial IrradiationRadiation
Also called Immunotherapy
The extensive-stage SCLC patients will receive prophylactic cranial irradiation ±immunotherapy after standard first-line chemotherapy combined with immunotherapy, until disease progression or death
| Study group | Role | What they receive |
|---|---|---|
| prophylactic cranial irradiation group | The extensive-stage SCLC patients will receive prophylactic cranial irradiation after standard first-line chemotherapy combined with immunotherapy, until disease progression or death. Receives: Radiation: Prophylactic Cranial Irradiation | |
| Observation group | Patients with extensive-stage SCLC do not receive preventive craniocerebral irradiation after standard first-line chemotherapy combined with immunotherapy until the disease progresses or death. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival in the brain
The length of time during and after treatment for a disease in which the patient lives with the disease but the intracranial lesions do not worsen
Measured: 1 year
Secondary outcomes (4)
Progression-free survival (PFS)
The length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse
Measured: 1 year
Overall survival (OS)
The time from treatment to death from any cause
Measured: 1 year
Adverse events
The incidence and severity of adverse events related to treatments
Measured: 1 year
The cognitive function of the patient
Use the Montreal Cognitive Screening Scale (MoCA) to score, the total score is 30 points, ≥26 points are normal
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Nov 2020
- Primary completionJan 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Extensive-stage Small-cell Lung 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luhua Wang, Chinese Academy of Medical Sciences
- Investigators
- Bi Nan, MD, Study director, Cancer Hospital, CAMS and PUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947774
- Sponsor's protocol ID
- NCC2622
- Status last verified
- Sep 2021
- First submitted
- 24 Jun 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
PubMed 25651787Chen W, Zheng R, Zhang S, Zeng H, Zuo T, Xia C, Yang Z, He J. Cancer incidence and mortality in China in 2013: an analysis based on urbanization level. Chin J Cancer Res. 2017 Feb;29(1):1-10. doi: 10.21147/j.issn.1000-9604.2017.01.01.
PubMed 28373748Takada M, Fukuoka M, Kawahara M, Sugiura T, Yokoyama A, Yokota S, Nishiwaki Y, Watanabe K, Noda K, Tamura T, Fukuda H, Saijo N. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with cisplatin and etoposide for limited-stage small-cell lung cancer: results of the Japan Clinical Oncology Group Study 9104. J Clin Oncol. 2002 Jul 15;20(14):3054-60. doi: 10.1200/JCO.2002.12.071.
PubMed 12118018Halthore A, Goenka A, Sharma R, Knisely JPS. Prophylactic Cranial Irradiation for Resectable Small-Cell Lung Cancer. Clin Lung Cancer. 2018 Mar;19(2):115-119. doi: 10.1016/j.cllc.2017.08.004. Epub 2017 Aug 26.
PubMed 28958889Edelman MJ. Prophylactic Cranial Irradiation for Small-Cell Lung Cancer: Time for a Reassessment. Am Soc Clin Oncol Educ Book. 2020 May;40:24-28. doi: 10.1200/EDBK_281041.
PubMed 32421453Janne PA, Freidlin B, Saxman S, Johnson DH, Livingston RB, Shepherd FA, Johnson BE. Twenty-five years of clinical research for patients with limited-stage small cell lung carcinoma in North America. Cancer. 2002 Oct 1;95(7):1528-38. doi: 10.1002/cncr.10841.
PubMed 12237922Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirillo J. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol. 2006 Oct 1;24(28):4539-44. doi: 10.1200/JCO.2005.04.4859.
PubMed 17008692Socinski MA, Smit EF, Lorigan P, Konduri K, Reck M, Szczesna A, Blakely J, Serwatowski P, Karaseva NA, Ciuleanu T, Jassem J, Dediu M, Hong S, Visseren-Grul C, Hanauske AR, Obasaju CK, Guba SC, Thatcher N. Phase III study of pemetrexed plus carboplatin compared with etoposide plus carboplatin in chemotherapy-naive patients with extensive-stage small-cell lung cancer. J Clin Oncol. 2009 Oct 1;27(28):4787-92. doi: 10.1200/JCO.2009.23.1548. Epub 2009 Aug 31.
PubMed 19720897Lara PN Jr, Natale R, Crowley J, Lenz HJ, Redman MW, Carleton JE, Jett J, Langer CJ, Kuebler JP, Dakhil SR, Chansky K, Gandara DR. Phase III trial of irinotecan/cisplatin compared with etoposide/cisplatin in extensive-stage small-cell lung cancer: clinical and pharmacogenomic results from SWOG S0124. J Clin Oncol. 2009 May 20;27(15):2530-5. doi: 10.1200/JCO.2008.20.1061. Epub 2009 Apr 6.
PubMed 19349543Rimner A, Wu AJ, Grills IS. What Is the Impact of Hippocampus Avoidance-Prophylactic Cranial Irradiation on Neurocognitive Preservation? J Thorac Oncol. 2021 May;16(5):722-724. doi: 10.1016/j.jtho.2021.02.026. No abstract available.
PubMed 33896571Wen P, Wang TF, Li M, Yu Y, Zhou YL, Wu CL. Meta-analysis of prophylactic cranial irradiation or not in treatment of extensive-stage small-cell lung cancer: The dilemma remains. Cancer Radiother. 2020 Feb;24(1):44-52. doi: 10.1016/j.canrad.2019.10.001. Epub 2020 Feb 7.
PubMed 32044160Spigel DR, Hainsworth JD, Shipley DL, Mekhail TM, Zubkus JD, Waterhouse DM, Daniel DB, Burris HA 3rd, Greco FA. Amrubicin and carboplatin with pegfilgrastim in patients with extensive stage small cell lung cancer: A phase II trial of the Sarah Cannon Oncology Research Consortium. Lung Cancer. 2018 Mar;117:38-43. doi: 10.1016/j.lungcan.2018.01.007. Epub 2018 Jan 12.
PubMed 29496254Pezzi TA, Fang P, Gjyshi O, Feng L, Liu S, Komaki R, Lin SH. Rates of Overall Survival and Intracranial Control in the Magnetic Resonance Imaging Era for Patients With Limited-Stage Small Cell Lung Cancer With and Without Prophylactic Cranial Irradiation. JAMA Netw Open. 2020 Apr 1;3(4):e201929. doi: 10.1001/jamanetworkopen.2020.1929.
PubMed 32236532Nosaki K, Seto T, Shimokawa M, Takahashi T, Yamamoto N. Is prophylactic cranial irradiation (PCI) needed in patients with extensive-stage small cell lung cancer showing complete response to first-line chemotherapy? Radiother Oncol. 2018 Jun;127(3):344-348. doi: 10.1016/j.radonc.2018.04.010. Epub 2018 May 7.
PubMed 29747871Yu J, Ouyang W, Yang Y, Zhang X, Zhou Y, Zhang J, Xie C. Prophylactic cranial irradiation for extensive-stage small cell lung cancer: Analysis based on active brain MRI surveillance. Clin Transl Radiat Oncol. 2020 Sep 15;25:16-21. doi: 10.1016/j.ctro.2020.09.005. eCollection 2020 Nov.
PubMed 32995574
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study of Prophylactic Cranial Irradiation After Immunotherapy Combined With Chemotherapy for Extensive-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04947774
- Acronym / sponsor ID
- NCC2622
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Keywords
- Small-cell Lung Cancer, Radiation:prophylactic cranial irradiation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 1 Jul 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.
The prognosis of extensive-stage small cell lung cancer is still very poor, even for those who received chemotherapy and immunotherapy. This experimental study is a real-world research design to evaluate the effectiveness and safety of prophylactic cranial irradiation in patients with extensive-stage small cell lung cancer who with first-line chemotherapy combined with immunotherapy.
Detailed description
This study is a prospective trial. This study included ES-SCLC patients who response after standard first-line treatment, and aimed to explore the safety and effectiveness of prophylactic cranial irradiation in this treatment modality.
The primary endpoint is progression-free survival in the brain.The secondary endpoints includes OS, PFS. The indicators for evaluating safety are the incidence and severity of adverse events.The exploratory endpoint is the molecular biomarkers for efficacy and toxicity predicting from tumor tissue and peripheral blood TMB.
The trial was designed by the National Cancer Center/Cancer Hospital of the Chinese Academy of Medical Sciences and Peking Union Medical College. The hypothesis is that preventive brain irradiation is safe and effective in the treatment of extensive SCLC combined with chemotherapy and immunotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prophylactic cranial irradiation group | – | Radiation: Prophylactic Cranial IrradiationThe extensive-stage SCLC patients will receive prophylactic cranial irradiation after standard first-line chemotherapy combined with immunotherapy, until disease progression or death. |
| Observation group | – | –Patients with extensive-stage SCLC do not receive preventive craniocerebral irradiation after standard first-line chemotherapy combined with immunotherapy until the disease progresses or death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is planned to enroll patients who have completed and response to first-line chemotherapy combined with immunotherapy, Later immunotherapy treatments are open
Key inclusion criteria (8 listed)
- Sign written informed consent;
- With extensive small cell lung cancer;
- Previously received first-line standard chemotherapy, with treatment response of CR or PR;
- Can tolerate the radiotherapy process;
- Be over 18 years old
Key exclusion criteria (5 listed)
- Exclude subjects with central nervous system (CNS) metastasis at the first diagnosis;
- Pregnancy or breastfeeding;
- Any other conclusive medical, psychiatric and/or social reasons determined by the researcher;
- Subjects who have previously suffered from other malignant tumors (excluding non-melanoma skin cancer and the following carcinoma in situ: bladder, stomach, colon, endometrial, cervical/dysplasia, melanoma or breast cancer) are not allowed to participate in the study. Unless he/she has been in complete remission at least 2 years before enrolling in the study, and does not need to receive other treatments or does not need to receive other treatments during the study;
- Researchers believe that the treatment methods used in the study can cause harm or cause basic diseases whose toxicity is difficult to judge when judging adverse events.
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 |
|---|---|---|
| Prophylactic Cranial IrradiationAlso: ImmunotherapyThe extensive-stage SCLC patients will receive prophylactic cranial irradiation ±immunotherapy after standard first-line chemotherapy combined with immunotherapy, until disease progression or death | Radiation | prophylactic cranial irradiation group |
Primary outcome
Progression-free survival in the brain
Time frame: 1 year
The length of time during and after treatment for a disease in which the patient lives with the disease but the intracranial lesions do not worsen
4 secondary outcomes
Progression-free survival (PFS)
Time frame: 1 year
Overall survival (OS)
Time frame: 1 year
Adverse events
Time frame: 1 year
The cognitive function of the patient
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Background: PubMed 25651787Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
- Background: PubMed 28373748Chen W, Zheng R, Zhang S, Zeng H, Zuo T, Xia C, Yang Z, He J. Cancer incidence and mortality in China in 2013: an analysis based on urbanization level. Chin J Cancer Res. 2017 Feb;29(1):1-10. doi: 10.21147/j.issn.1000-9604.2017.01.01.
- Background: PubMed 12118018Takada M, Fukuoka M, Kawahara M, Sugiura T, Yokoyama A, Yokota S, Nishiwaki Y, Watanabe K, Noda K, Tamura T, Fukuda H, Saijo N. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with cisplatin and etoposide for limited-stage small-cell lung cancer: results of the Japan Clinical Oncology Group Study 9104. J Clin Oncol. 2002 Jul 15;20(14):3054-60. doi: 10.1200/JCO.2002.12.071.
- Background: PubMed 28958889Halthore A, Goenka A, Sharma R, Knisely JPS. Prophylactic Cranial Irradiation for Resectable Small-Cell Lung Cancer. Clin Lung Cancer. 2018 Mar;19(2):115-119. doi: 10.1016/j.cllc.2017.08.004. Epub 2017 Aug 26.
- Background: PubMed 32421453Edelman MJ. Prophylactic Cranial Irradiation for Small-Cell Lung Cancer: Time for a Reassessment. Am Soc Clin Oncol Educ Book. 2020 May;40:24-28. doi: 10.1200/EDBK_281041.
- Background: PubMed 12237922Janne PA, Freidlin B, Saxman S, Johnson DH, Livingston RB, Shepherd FA, Johnson BE. Twenty-five years of clinical research for patients with limited-stage small cell lung carcinoma in North America. Cancer. 2002 Oct 1;95(7):1528-38. doi: 10.1002/cncr.10841.
- Background: PubMed 17008692Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirillo J. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol. 2006 Oct 1;24(28):4539-44. doi: 10.1200/JCO.2005.04.4859.
- Background: PubMed 19720897Socinski MA, Smit EF, Lorigan P, Konduri K, Reck M, Szczesna A, Blakely J, Serwatowski P, Karaseva NA, Ciuleanu T, Jassem J, Dediu M, Hong S, Visseren-Grul C, Hanauske AR, Obasaju CK, Guba SC, Thatcher N. Phase III study of pemetrexed plus carboplatin compared with etoposide plus carboplatin in chemotherapy-naive patients with extensive-stage small-cell lung cancer. J Clin Oncol. 2009 Oct 1;27(28):4787-92. doi: 10.1200/JCO.2009.23.1548. Epub 2009 Aug 31.
- Background: PubMed 19349543Lara PN Jr, Natale R, Crowley J, Lenz HJ, Redman MW, Carleton JE, Jett J, Langer CJ, Kuebler JP, Dakhil SR, Chansky K, Gandara DR. Phase III trial of irinotecan/cisplatin compared with etoposide/cisplatin in extensive-stage small-cell lung cancer: clinical and pharmacogenomic results from SWOG S0124. J Clin Oncol. 2009 May 20;27(15):2530-5. doi: 10.1200/JCO.2008.20.1061. Epub 2009 Apr 6.
- Background: PubMed 33896571Rimner A, Wu AJ, Grills IS. What Is the Impact of Hippocampus Avoidance-Prophylactic Cranial Irradiation on Neurocognitive Preservation? J Thorac Oncol. 2021 May;16(5):722-724. doi: 10.1016/j.jtho.2021.02.026. No abstract available.
- Background: PubMed 32044160Wen P, Wang TF, Li M, Yu Y, Zhou YL, Wu CL. Meta-analysis of prophylactic cranial irradiation or not in treatment of extensive-stage small-cell lung cancer: The dilemma remains. Cancer Radiother. 2020 Feb;24(1):44-52. doi: 10.1016/j.canrad.2019.10.001. Epub 2020 Feb 7.
- Background: PubMed 29496254Spigel DR, Hainsworth JD, Shipley DL, Mekhail TM, Zubkus JD, Waterhouse DM, Daniel DB, Burris HA 3rd, Greco FA. Amrubicin and carboplatin with pegfilgrastim in patients with extensive stage small cell lung cancer: A phase II trial of the Sarah Cannon Oncology Research Consortium. Lung Cancer. 2018 Mar;117:38-43. doi: 10.1016/j.lungcan.2018.01.007. Epub 2018 Jan 12.
- 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.
Bi Nan, MD study director
Cancer Hospital, CAMS and PUMC
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 Extensive-stage Small-cell Lung Cancer, run by Chinese Academy of Medical Sciences 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 8 inclusion and 5 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 22 Sep 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 Liu Wen-Yang, MD (8613810753633, liuwenyang26@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival in the brain (time frame: 1 year). 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 NCT04947774, which also lists 16 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 22 Sep 2021.