Pancreas AdenocarcinomaLUMACANCT04435067
Evaluation of Clinical, Radiomics and Molecular Features of Lung Metastasis in PDAC Patients (LUMACA Trial)
An observational study of Pancreas Adenocarcinoma, run by IRCCS San Raffaele at 4 sites in Italy.
Trial summary
The aim of this study is the characterization from epidemiological, radiomics and molecular point of view of lung metastasis of patients at beginning affected by pancreatic adenocarcinoma (PDAC), which after the resection of primitive tumor have met with initial recurrence of the disease exclusively at the lung level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Adenocarcinoma
- What is being tested?
- Analysis of genetic mutations and the gene expression profile of lung metastasis and primary neoplasia and Radiomics analysis on TAC imaging at diagnosis of lung metastasis and, if possible, of the primary tumor
- How many people
- 44 participants
- Where
- 4 sitesItaly
- Study dates
- 27 May 2020to 31 Dec 2021
- 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: All patients with a confirmed diagnosis of lung metastasis from PDAC from 2008 to 2019
Who may be able to join
- Cytological/histological diagnosis of pancreatic adenocarcinoma as a primary tumor and localization of adenocarcinoma compatible with pancreatic primitivity for lung metastasis;
- Previous surgical resection of the primary tumor;
- Exclusive presence of single or multiple lung metastasis at disease recurrence;
- Radical or diagnostic excision of lung metastasis;
- Informed patient consent (for currently living patients).
Who cannot join
- Patients not undergoing lung resection surgery for diagnostic and/or therapeutic purposes for cardiac or respiratory functional contraindication.
- Patients with lung metastases synchronous with primary cancer. Contacts and Locations
Trial locations and contacts
4 sites in 1 country.
Italy4 sites, 4 recruiting
- Recruiting
IRCCS San Raffaele Diagnostic Radiology Unit
Milan, 20132
Francesco De Cobelli, Prof., +390226433434, decobelli.francesco@hsr.it
Diego Palumbo, MD, +390226432388, palumbo.diego@hsr.it
- Recruiting
IRCCS San Raffaele Medical Oncology Unit
Milan, 20132
Giulia Orsi, MD, +39 02 26437602, orsi.giulia@hsr.it
Maria Maddalena Valente, PhD, +39 02 26437623, valente.mariamaddalena@hsr.it
- Recruiting
IRCCS San Raffaele Pathological Anatomy Unit
Milan, 20132
Claudio Doglioni, Prof., +390226432511, doglioni.claudio@hsr.it
- Recruiting
IRCCS San Raffaele Thoracic Surgery Unit
Milan, 20132
Giampiero Negri, Prof., +390226437128, negri.giampiero@hsr.it
Angelo Carretta, MD, +390226437132, carretta.angelo@hsr.it
About this study
Official title: Retrospective Observational Study on Patients With Lung Metastases From Pancreatic Adenocarcinoma: Evaluation of Clinical Features and Correlation With Molecular and Radiomics Features
The aim of this study is the characterization from epidemiological, radiomics and molecular point of view of lung metastasis of patients at beginning affected by pancreatic adenocarcinoma (PDAC), which after the resection of primitive tumor have met with initial recurrence of the disease exclusively at the lung level.
Read the detailed description
Radical surgical treatment of primitive PDAC, associated with adjuvant cancer treatments, is possible only in 15-20% of patients, and, to date, represents the best therapeutic strategy. Nevertheless, remote recurrence is frequent after radical surgical treatment of primitive neoplasia. Among the main locations of metastasis from PDAC, the lung represent the second metastatic location with a better prognosis than other remote metastasis. Surgical treatment of lung metastasis has a consolidated role in the treatment of other neoplasms such as sarcomas, colorectal and renal neoplasms while in the context of PDAC the resection of lung metastases is a rather rare and also debated event.
In absence of consolidated data on the results of surgical treatment and on the clinical outcomes of patients with lung metastasis from PDAC the investigators designed this retrospective observational study in order to analyze the clinical and pathological characteristics of patients suffering from lung metastasis from PDAC treated at San Raffaele Hospital in a period between 2008 and 2019. To this purpose, the investigators will analyze and compare two patient cohorts: 1-patients in whom lung metastasis were resected for therapeutic purposes; 2-patients in whom lung metastasis were removed for diagnostic purposes only.
An analysis of genetic mutations and the gene expression profile of lung metastasis and primary neoplasia will also be performed to evaluate any predictive elements of lung metastasis and the prognostic role of these mutations.
In parallel, the investigators will perform radiomics analysis on TAC imaging at diagnosis of lung metastasis and, if possible, of the primary tumor.
All the data necessary for the completion of the study were collected as part of the usual outpatient visits in the appropriate outpatient medical records and include: date of birth, date of diagnosis, gender, performance status, stage of the disease, comorbidity, concomitant chronic therapies, level of tumor markers (CEA and Ca19.9) before treatment and variations during therapy, type of chemotherapy, start and end date of chemotherapy, number of cycles, possible dosage reduction of the drugs used in the various chemotherapy regimes, dates and results of instrumental revaluations according to RECIST 1.1, main chemotherapy toxicities and grade according to CTCAE 5.0, date and type of surgery, mutation analysis results and last follow-up date. In the event of death, the dates of death are communicated by the registry office of the municipality of residence of the patient, according to the official procedure. All data will be collected in an electronic database in coded form (pseudonymization).
Power size calculation:
All patients who meet the inclusion and exclusion criteria and who have been treated at the Medical Oncology and Thoracic Surgery Units of the San Raffaele Hospital between 2008 and 2019 will be taken into consideration, for a total of 44 patients. To identify predictive and/or prognostic clinical and pathological factors that can influence the outcome of these patients, the two cohorts described above will be analyzed and compared through univariate and multivariate analyzes. Overall survival (OS) and progression-free survival (PFS) will also be assessed using the Kaplan Meier method and the long-rank test will be used to compare OS and PFS between the two cohorts under study. All tests will be double-tailed and a p <0.05 will be considered significant. The ninety-five percent confidence intervals (CI) will be calculated to assess the accuracy of the estimates obtained.
- Conditions
- Pancreas Adenocarcinoma
- Being tested
- Analysis of genetic mutations and the gene expression profile of lung metastasis and primary neoplasia, Radiomics analysis on TAC imaging at diagnosis of lung metastasis and, if possible, of the primary tumor
- Keywords
- Pancreas Adenocarcinoma, Lung Metastasis, Gene Expression, Molecular analysis, Radiomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of genetic mutations and the gene expression profile of lung metastasis and primary neoplasiaGenetic
The mutational analysis of the main oncogenes and tumor suppressor genes involved in the genesis and tumor progression will be performed on the genomic DNA extracted from each sample using the Ion Torrent TM Oncomine TM Comprehensive Assay version 3 (OCAv3) kit. This panel includes 161 cancer-related genes and allows the identification of all genomic alterations affecting oncogenes and recurrently altered tumor suppressor genes in solid tumors. The study of gene expression will be carried out using Nanostring Technology using the Pancancer IO 360 TM panel which allows simultaneous analysis for each sample of multiple mRNAs associated with crucial pathways in carcinogenesis and the immunological profile of the tumor, defining its up and down conditions gene regulation.
Radiomics analysis on TAC imaging at diagnosis of lung metastasis and, if possible, of the primary tumorOther
This study will be performed using the SPAARC IBSI (International Biomarker Standardization Initiative) compliant software implemented in the MatLab environment (MathWorks, Boston, USA) through several steps: (a) CT imaging retrieval, (b) image segmentation and rendering, (c) feature extraction and (d) qualification/quantification. Approximately 200 radiomics characteristics will be extracted, such as: Morphology, Statistical, Intensity Histogram, Gray Level Co-occurrence Matrix 3D_average, Gray Level Co-occurrence Matrix 3D_combined, Gray Level Run Length 3D_average, Gray Level Run Length 3D_combined, Gray Level Size Zone Matrix 3D, Neighbor Gray Tone Difference Matrix 3D, Gray Level Distance Zone Matrix 3D.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | patients in whom lung metastasis were resected for therapeutic purposes Receives: Genetic: Analysis of genetic mutations and the gene expression profile of lung metastasis and primary neoplasia; Other: Radiomics analysis on TAC imaging at diagnosis of lung metastasis and, if possible, of the primary tumor | |
| Cohort B | patients in whom lung metastasis were removed for diagnostic purposes only Receives: Genetic: Analysis of genetic mutations and the gene expression profile of lung metastasis and primary neoplasia; Other: Radiomics analysis on TAC imaging at diagnosis of lung metastasis and, if possible, of the primary tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and pathological features of lung metastasis
Analyze the clinical and pathological characteristics of the two cohorts of patients affected by lung metastasis from PDAC
Measured: 6 months
Secondary outcomes (2)
Molecular and radiomics features of lung metastasis
Correlate the pathological characteristics of the two cohorts of patients affected by lung metastasis from PDAC with radiomics and molecular features, in order to identify prognostic and/or predictive factors related to lung metastasis in the PDAC
Measured: 18 months
Differences between the two cohorts
Highlight any differences between the two cohorts of patients examined
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start27 May 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pancreas AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Retrospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Reni, IRCCS San Raffaele
- Investigators
- Michele Reni, MD, Principal investigator, IRCCSS Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435067
- Sponsor's protocol ID
- PACT32
- Acronym
- LUMACA
- Status last verified
- Jul 2020
- First submitted
- 14 Jun 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arnaoutakis GJ, Rangachari D, Laheru DA, Iacobuzio-Donahue CA, Hruban RH, Herman JM, Edil BH, Pawlik TM, Schulick RD, Cameron JL, Meneshian A, Yang SC, Wolfgang CL. Pulmonary resection for isolated pancreatic adenocarcinoma metastasis: an analysis of outcomes and survival. J Gastrointest Surg. 2011 Sep;15(9):1611-7. doi: 10.1007/s11605-011-1605-8. Epub 2011 Jul 2.
PubMed 21725701Ceppa DP. Results of Pulmonary Resection: Sarcoma and Germ Cell Tumors. Thorac Surg Clin. 2016 Feb;26(1):49-54. doi: 10.1016/j.thorsurg.2015.09.007.
PubMed 26611510Okui M, Yamamichi T, Asakawa A, Harada M, Horio H. Resection for Pancreatic Cancer Lung Metastases. Korean J Thorac Cardiovasc Surg. 2017 Oct;50(5):326-328. doi: 10.5090/kjtcs.2017.50.5.326. Epub 2017 Oct 5.
PubMed 29124023Rama N, Monteiro A, Bernardo JE, Eugenio L, Antunes MJ. Lung metastases from colorectal cancer: surgical resection and prognostic factors. Eur J Cardiothorac Surg. 2009 Mar;35(3):444-9. doi: 10.1016/j.ejcts.2008.10.047. Epub 2009 Jan 10.
PubMed 19136273Yamashita K, Miyamoto A, Hama N, Asaoka T, Maeda S, Omiya H, Takami K, Doki Y, Mori M, Nakamori S. Survival Impact of Pulmonary Metastasis as Recurrence of Pancreatic Ductal Adenocarcinoma. Dig Surg. 2015;32(6):464-71. doi: 10.1159/000439545. Epub 2015 Oct 31.
PubMed 26517228
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study on Patients With Lung Metastases From Pancreatic Adenocarcinoma: Evaluation of Clinical Features and Correlation With Molecular and Radiomics Features
- ClinicalTrials.gov ID
- NCT04435067
- Acronym / sponsor ID
- LUMACA / PACT32
- Conditions
- Pancreas Adenocarcinoma
- Keywords
- Pancreas Adenocarcinoma, Lung Metastasis, Gene Expression, Molecular analysis, Radiomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Jun 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.
The aim of this study is the characterization from epidemiological, radiomics and molecular point of view of lung metastasis of patients at beginning affected by pancreatic adenocarcinoma (PDAC), which after the resection of primitive tumor have met with initial recurrence of the disease exclusively at the lung level.
Detailed description
Radical surgical treatment of primitive PDAC, associated with adjuvant cancer treatments, is possible only in 15-20% of patients, and, to date, represents the best therapeutic strategy. Nevertheless, remote recurrence is frequent after radical surgical treatment of primitive neoplasia. Among the main locations of metastasis from PDAC, the lung represent the second metastatic location with a better prognosis than other remote metastasis. Surgical treatment of lung metastasis has a consolidated role in the treatment of other neoplasms such as sarcomas, colorectal and renal neoplasms while in the context of PDAC the resection of lung metastases is a rather rare and also debated event.
In absence of consolidated data on the results of surgical treatment and on the clinical outcomes of patients with lung metastasis from PDAC the investigators designed this retrospective observational study in order to analyze the clinical and pathological characteristics of patients suffering from lung metastasis from PDAC treated at San Raffaele Hospital in a period between 2008 and 2019. To this purpose, the investigators will analyze and compare two patient cohorts: 1-patients in whom lung metastasis were resected for therapeutic purposes; 2-patients in whom lung metastasis were removed for diagnostic purposes only.
An analysis of genetic mutations and the gene expression profile of lung metastasis and primary neoplasia will also be performed to evaluate any predictive elements of lung metastasis and the prognostic role of these mutations.
In parallel, the investigators will perform radiomics analysis on TAC imaging at diagnosis of lung metastasis and, if possible, of the primary tumor.
All the data necessary for the completion of the study were collected as part of the usual outpatient visits in the appropriate outpatient medical records and include: date of birth, date of diagnosis, gender, performance status, stage of the disease, comorbidity, concomitant chronic therapies, level of tumor markers (CEA and Ca19.9) before treatment and variations during therapy, type of chemotherapy, start and end date of chemotherapy, number of cycles, possible dosage reduction of the drugs used in the various chemotherapy regimes, dates and results of instrumental revaluations according to RECIST 1.1, main chemotherapy toxicities and grade according to CTCAE 5.0, date and type of surgery, mutation analysis results and last follow-up date. In the event of death, the dates of death are communicated by the registry office of the municipality of residence of the patient, according to the official procedure. All data will be collected in an electronic database in coded form (pseudonymization).
Power size calculation:
All patients who meet the inclusion and exclusion criteria and who have been treated at the Medical Oncology and Thoracic Surgery Units of the San Raffaele Hospital between 2008 and 2019 will be taken into consideration, for a total of 44 patients. To identify predictive and/or prognostic clinical and pathological factors that can influence the outcome of these patients, the two cohorts described above will be analyzed and compared through univariate and multivariate analyzes. Overall survival (OS) and progression-free survival (PFS) will also be assessed using the Kaplan Meier method and the long-rank test will be used to compare OS and PFS between the two cohorts under study. All tests will be double-tailed and a p <0.05 will be considered significant. The ninety-five percent confidence intervals (CI) will be calculated to assess the accuracy of the estimates obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Genetic: Analysis of genetic mutations and the gene expression profile of lung metastasis and primary neoplasia, Other: Radiomics analysis on TAC imaging at diagnosis of lung metastasis and, if possible, of the primary tumorpatients in whom lung metastasis were resected for therapeutic purposes |
| Cohort B | – | Genetic: Analysis of genetic mutations and the gene expression profile of lung metastasis and primary neoplasia, Other: Radiomics analysis on TAC imaging at diagnosis of lung metastasis and, if possible, of the primary tumorpatients in whom lung metastasis were removed for diagnostic purposes only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a confirmed diagnosis of lung metastasis from PDAC from 2008 to 2019
Key inclusion criteria (5 listed)
- Cytological/histological diagnosis of pancreatic adenocarcinoma as a primary tumor and localization of adenocarcinoma compatible with pancreatic primitivity for lung metastasis;
- Previous surgical resection of the primary tumor;
- Exclusive presence of single or multiple lung metastasis at disease recurrence;
- Radical or diagnostic excision of lung metastasis;
- Informed patient consent (for currently living patients).
Key exclusion criteria (2 listed)
- Patients not undergoing lung resection surgery for diagnostic and/or therapeutic purposes for cardiac or respiratory functional contraindication.
- Patients with lung metastases synchronous with primary cancer. Contacts and Locations
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 |
|---|---|---|
| Analysis of genetic mutations and the gene expression profile of lung metastasis and primary neoplasiaThe mutational analysis of the main oncogenes and tumor suppressor genes involved in the genesis and tumor progression will be performed on the genomic DNA extracted from each sample using the Ion Torrent TM Oncomine TM Comprehensive Assay version 3 (OCAv3) kit. This panel includes 161 cancer-related genes and allows the identification of all genomic alterations affecting oncogenes and recurrently altered tumor suppressor genes in solid tumors. The study of gene expression will be carried out using Nanostring Technology using the Pancancer IO 360 TM panel which allows simultaneous analysis for each sample of multiple mRNAs associated with crucial pathways in carcinogenesis and the immunological profile of the tumor, defining its up and down conditions gene regulation. | Genetic | Cohort A, Cohort B |
| Radiomics analysis on TAC imaging at diagnosis of lung metastasis and, if possible, of the primary tumorThis study will be performed using the SPAARC IBSI (International Biomarker Standardization Initiative) compliant software implemented in the MatLab environment (MathWorks, Boston, USA) through several steps: (a) CT imaging retrieval, (b) image segmentation and rendering, (c) feature extraction and (d) qualification/quantification. Approximately 200 radiomics characteristics will be extracted, such as: Morphology, Statistical, Intensity Histogram, Gray Level Co-occurrence Matrix 3D_average, Gray Level Co-occurrence Matrix 3D_combined, Gray Level Run Length 3D_average, Gray Level Run Length 3D_combined, Gray Level Size Zone Matrix 3D, Neighbor Gray Tone Difference Matrix 3D, Gray Level Distance Zone Matrix 3D. | Other | Cohort A, Cohort B |
Primary outcome
Clinical and pathological features of lung metastasis
Time frame: 6 months
Analyze the clinical and pathological characteristics of the two cohorts of patients affected by lung metastasis from PDAC
2 secondary outcomes
Molecular and radiomics features of lung metastasis
Time frame: 18 months
Differences between the two cohorts
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Background: PubMed 21725701Arnaoutakis GJ, Rangachari D, Laheru DA, Iacobuzio-Donahue CA, Hruban RH, Herman JM, Edil BH, Pawlik TM, Schulick RD, Cameron JL, Meneshian A, Yang SC, Wolfgang CL. Pulmonary resection for isolated pancreatic adenocarcinoma metastasis: an analysis of outcomes and survival. J Gastrointest Surg. 2011 Sep;15(9):1611-7. doi: 10.1007/s11605-011-1605-8. Epub 2011 Jul 2.
- Background: PubMed 26611510Ceppa DP. Results of Pulmonary Resection: Sarcoma and Germ Cell Tumors. Thorac Surg Clin. 2016 Feb;26(1):49-54. doi: 10.1016/j.thorsurg.2015.09.007.
- Background: PubMed 29124023Okui M, Yamamichi T, Asakawa A, Harada M, Horio H. Resection for Pancreatic Cancer Lung Metastases. Korean J Thorac Cardiovasc Surg. 2017 Oct;50(5):326-328. doi: 10.5090/kjtcs.2017.50.5.326. Epub 2017 Oct 5.
- Background: PubMed 19136273Rama N, Monteiro A, Bernardo JE, Eugenio L, Antunes MJ. Lung metastases from colorectal cancer: surgical resection and prognostic factors. Eur J Cardiothorac Surg. 2009 Mar;35(3):444-9. doi: 10.1016/j.ejcts.2008.10.047. Epub 2009 Jan 10.
- Background: PubMed 26517228Yamashita K, Miyamoto A, Hama N, Asaoka T, Maeda S, Omiya H, Takami K, Doki Y, Mori M, Nakamori S. Survival Impact of Pulmonary Metastasis as Recurrence of Pancreatic Ductal Adenocarcinoma. Dig Surg. 2015;32(6):464-71. doi: 10.1159/000439545. Epub 2015 Oct 31.
- Individual participant dataSharing planned: No
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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.
Michele Reni, MD principal investigator
IRCCSS Raffaele
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Adenocarcinoma, run by IRCCS San Raffaele at 4 sites in Italy.
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 2 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 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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 Giulia Orsi, MD (+390226437602, orsi.giulia@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and pathological features of lung metastasis (time frame: 6 months). 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 NCT04435067, which also lists 5 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 16 Jul 2020.