Breast CancerNCT03662204
Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
An observational study of Breast Cancer and Lung Cancer, run by Exact Sciences Corporation at 119 sites in United States.
Trial summary
The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Colorectal Cancer
- What is being tested?
- Blood Sample Collection
- How many people
- 5,133 participants
- Where
- 119 sitesUnited States
- Study dates
- 23 Aug 2018to 31 Mar 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: Approximately 7500 subjects will be enrolled. Subjects will be men and women, 18 years of age and older, who have an untreated breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or esophageal cancer.
Who may be able to join
- Subject is male or female > 18 years of age.
- Subject has an untreated primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or esophageal cancer.
- OR
- Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, or ovarian cancer based on imaging.
- Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Who cannot join
- Prior or concurrent cancer diagnosis defined as:
- Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
- Recurrence of the same primary cancer within any timeframe; OR
- Concurrent diagnosis of multiple primary cancers
- Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
- Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection.
Show all 10Show fewer
- Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
- Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
- IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
119 sites in 1 country.
119 sites in 1 country
United States119 sites
Albany Medical College
Albany, New York, 12208
PMG Research of McFarland Clinic
Ames, Iowa, 50010
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
Piedmont Cancer Institute, PC
Atlanta, Georgia, 30318
RMR VA Medical Center
Aurora, Colorado, 80045
Greater Baltimore Medical Center
Baltimore, Maryland, 68506
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Beverly Hospital, Oncology
Beverly, Massachusetts, 01915
Massachusetts General Hospital
Boston, Massachusetts, 02114
PMG Research of Bristol, LLC
Bristol, Tennessee, 37620
Brooklyn Urology Research Group
Brooklyn, New York, 11201
Roswell Park Cancer Institute
Buffalo, New York, 14263
Seattle Urology Research Center
Burien, Washington, 98166
Hematology & Oncology Associates, Inc.
Canton, Ohio, 44708
Charleston Cancer Center
Charleston, South Carolina, 29406
CAMC Clinical Trials Center
Charleston, West Virginia, 25304
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612
John Muir Clinical Research
Concord, California, 94520
Christus Spohn Cancer Center
Corpus Christi, Texas, 78404
The Urology Center of Colorado
Denver, Colorado, 80211
Des Moines Oncology Research Associate
Des Moines, Iowa, 50309
PMG Research of DuPage Medical Group
Downers Grove, Illinois, 60515
Hematology Oncology Associates of Central New York
East Syracuse, New York, 13057
Oncology Fort Thomas St. Elizabeth's Edgewood Cancer Care Research
Edgewood, Kentucky, 41017
McLeod Center for Cancer Treatment and Research
Florence, South Carolina, 29506
Southeast Florida Hematology-Oncology Group, PA
Fort Lauderdale, Florida, 33308
Mercy Research-Fort Smith
Fort Smith, Arkansas, 72903
Cancer and Hematology Centers of Western Michigan, PC
Grand Rapids, Michigan, 49503
Cancer Research Consortium of West Michigan (CRCWM)
Grand Rapids, Michigan, 49503
HSHS St. Vincent Hospital
Green Bay, Wisconsin, 54301
Marin Cancer Care
Greenbrae, California, 94904
Cone Health Cancer Center
Greensboro, North Carolina, 27403
Saint Francis Cancer Center Research Department
Greenville, South Carolina, 29607
PMG Research of Hickory, LLC
Hickory, North Carolina, 28601
Genesis Cancer Center
Hot Springs, Arkansas, 71913
University of Texas Health Science Center
Houston, Texas, 77030
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, 46260
St. Dominic's Gynecologic Oncology
Jackson, Mississippi, 39216
The Jackson Clinic
Jackson, Tennessee, 38301
CSNF - Central Business Office
Jacksonville, Florida, 32256
Michael Berry Building-Oncology
Janesville, Wisconsin, 53548
Presence Cancer Care / JOHA
Joliet, Illinois, 60435
NEA Fowler Family Center for Cancer Care
Jonesboro, Arkansas, 72401
Mercy Cancer Center
Joplin, Missouri, 64804
Jupiter Medical Center
Jupiter, Florida, 33458
Alliance Research Centers
Laguna Hills, California, 92653
Cancer Centers of Southwest Oklahoma
Lawton, Oklahoma, 73505
Baptist Health-Lexington
Lexington, Kentucky, 40503
Nebraska Hematology-Oncology -- Lincoln
Lincoln, Nebraska, 68506
Somnos Laboratories, Inc.
Lincoln, Nebraska, 68510
CARTI Cancer Center
Little Rock, Arkansas, 72205
Norton Cancer Institute-Pavilion
Louisville, Kentucky, 40202
Baptist Health
Louisville, Kentucky, 40207
Lowell General Hospital
Lowell, Massachusetts, 01854
UW Carbone Cancer Center
Madison, Wisconsin, 53792
Tri-County Hematology & Oncology Associates, Inc.
Massillon, Ohio, 44646
Mount Sinai Medical Center
Miami Beach, Florida, 33140
The Minniti Center for Hematology and Oncology
Mickleton, New Jersey, 08056
Middlesex Hospital
Middletown, Connecticut, 06457
Mon Health Medical Center
Morgantown, West Virginia, 26505
West Virginia University Cancer Institute
Morgantown, West Virginia, 26506
Office of John Homan, MD
Newport Beach, California, 92663
Lowcountry Urology/PMG Research of Charleston, LLC
North Charleston, South Carolina, 29406
Easter Ct Hematology and Oncology
Norwich, Connecticut, 06360
North County Oncology
Oceanside, California, 92056
Community Cancer Trials of Utah
Ogden, Utah, 84405
Genie Jackson Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Mercy Oncology Research
Oklahoma City, Oklahoma, 73120
UCI Department of Urology
Orange, California, 92868
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
Baptist Health- Paducah
Paducah, Kentucky, 42001
Illinois CancerCare, P.C.
Peoria, Illinois, 61615
Mayo Clinic Hospital
Phoenix, Arizona, 85054
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, 12601
Premier Medical Group of the Hudson Valley, PC Research Department - Gastroenterology Division
Poughkeepsie, New York, 12601
Women & Infants Hospital
Providence, Rhode Island, 02905
RH Clinical Research
Rapid City, South Dakota, 57701
Riverview Medical Center
Red Bank, New Jersey, 07701
Cancer Care Specialists
Reno, Nevada, 89519
Virginia Cancer Institute
Richmond, Virginia, 23230
PMG Research of Rocky Mount
Rocky Mount, North Carolina, 27804
Metro-Minnesota Community Oncology Research Consortium (MMCORC)
Saint Louis Park, Minnesota, 55416
Park Nicollet Institute - Oncology Research
Saint Louis Park, Minnesota, 55426
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Sun Research Institute
San Antonio, Texas, 78215
San Antonio Military Medical Center
San Antonio, Texas, 78234
Sharp Memorial Hospital
San Diego, California, 92123
St. Joseph Heritage Healthcare
Santa Rosa, California, 95403
Sarasota Memorial Hospital
Sarasota, Florida, 34203
Candler Hospital
Savannah, Georgia, 31405
Scottsdale Medical Imaging Research
Scottsdale, Arizona, 85258
Holy Cross Hospital Resource Center Department of Cancer Research
Silver Spring, Maryland, 20902
Orchard Healthcare Reasearch Inc
Skokie, Illinois, 60077
Ascension Providence Hospitals
Southfield, Michigan, 48075
Spartanburg Medical Center: Gibbs Cancer Center & Research Institute
Spartanburg, South Carolina, 29303
SIU School of Medicine
Springfield, Illinois, 62702
Mercy Cancer and Hematology Clinic
Springfield, Missouri, 65804
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Mercy Hospital
St Louis, Missouri, 63141
Adventist Health - Saint Helena Hospital
St. Helena, California, 94574
Stamford Hospital
Stamford, Connecticut, 06904
Richmond University Medical Center
Staten Island, New York, 10310
PMG Research of Piedmont
Statesville, North Carolina, 28625
Stony Brook Cancer Center
Stony Brook, New York, 11794
Associated Medical Professionals
Syracuse, New York, 13210
MultiCare Regional Cancer Center
Tacoma, Washington, 98405
Cancer Treatment Center
Texarkana, Texas, 75503
Renovatio Clinical
The Woodlands, Texas, 77380
Lewis Hall Singletary Oncology Center
Thomasville, Georgia, 31792
Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85715
Urological Associates of Southern Arizona, PC
Tucson, Arizona, 85741
North Mississippi Medical Center Hematology and Oncology
Tupelo, Mississippi, 38801
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462
Marion L. Shepard Cancer Center
Washington, North Carolina, 27889
ProHealth Care Research Institute
Waukesha, Wisconsin, 53188
Lexington Medical Center
West Columbia, South Carolina, 29169
Innovative Clinical Research Institute
Whittier, California, 90603
Zimmer Cancer Center
Wilmington, North Carolina, 28402
About this study
The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.
Read the detailed description
Subjects who have been diagnosed, or who have a suspicion of diagnosis based on imaging, with any solid tumor. Subjects will have a blood sample collected at enrollment and provide medical history prior to initiation of treatment. There will be no further follow-up.
- Conditions
- Breast Cancer, Lung Cancer, Colorectal Cancer, Prostate Cancer, Bladder Cancer, Uterine Cancer
- Being tested
- Blood Sample Collection
- Keywords
- blood draw, sample collection
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms, Urinary Bladder Neoplasms, Uterine Neoplasms, Kidney Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sample CollectionOther
Subjects participating in the study will have blood drawn at enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Breast | Subjects with clinically confirmed breast cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. Receives: Other: Blood Sample Collection | |
| Lung | Subjects with clinically confirmed lung cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. Receives: Other: Blood Sample Collection | |
| Colorectal | Subjects with clinically confirmed colorectal cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. Receives: Other: Blood Sample Collection | |
| Prostate | Subjects with clinically confirmed prostate cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. Receives: Other: Blood Sample Collection | |
| Bladder | Subjects with clinically confirmed or suspicion of bladder cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. Receives: Other: Blood Sample Collection | |
| Uterine | Subjects with clinically confirmed uterine cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. Receives: Other: Blood Sample Collection | |
| Kidney & Renal Pelvis | Subjects with clinically confirmed or suspicion of kidney or renal pelvis cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. Receives: Other: Blood Sample Collection | |
| Pancreatic | Subjects with clinically confirmed or suspicion of pancreatic cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. Receives: Other: Blood Sample Collection | |
| Liver | Subjects with clinically confirmed liver cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. Receives: Other: Blood Sample Collection | |
| Stomach | Subjects with clinically confirmed stomach cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. Receives: Other: Blood Sample Collection | |
| Ovarian | Subjects with clinically confirmed or suspicion of ovarian cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. Receives: Other: Blood Sample Collection | |
| Esophageal | Subjects with clinically confirmed esophageal cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. Receives: Other: Blood Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker Evaluation
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with solid tumor cancers.
Measured: Point in time (one day) blood collection at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start23 Aug 2018
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Cross-sectional
- Enrolment
- 5,133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662204
- Sponsor's protocol ID
- 2018-01
- Status last verified
- Aug 2022
- First submitted
- 30 Aug 2018
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol and informed consent form (when applicable) will also be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
- ClinicalTrials.gov ID
- NCT03662204
- Acronym / sponsor ID
- 2018-01
- Conditions
- Breast Cancer, Lung Cancer, Colorectal Cancer, Prostate Cancer, Bladder Cancer, Uterine Cancer
- Keywords
- blood draw, sample collection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,133 participants (actual)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 7 Sep 2018 (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 primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.
Detailed description
Subjects who have been diagnosed, or who have a suspicion of diagnosis based on imaging, with any solid tumor. Subjects will have a blood sample collected at enrollment and provide medical history prior to initiation of treatment. There will be no further follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Breast | – | Other: Blood Sample CollectionSubjects with clinically confirmed breast cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. |
| Lung | – | Other: Blood Sample CollectionSubjects with clinically confirmed lung cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. |
| Colorectal | – | Other: Blood Sample CollectionSubjects with clinically confirmed colorectal cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. |
| Prostate | – | Other: Blood Sample CollectionSubjects with clinically confirmed prostate cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. |
| Bladder | – | Other: Blood Sample CollectionSubjects with clinically confirmed or suspicion of bladder cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. |
| Uterine | – | Other: Blood Sample CollectionSubjects with clinically confirmed uterine cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. |
| Kidney & Renal Pelvis | – | Other: Blood Sample CollectionSubjects with clinically confirmed or suspicion of kidney or renal pelvis cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. |
| Pancreatic | – | Other: Blood Sample CollectionSubjects with clinically confirmed or suspicion of pancreatic cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. |
| Liver | – | Other: Blood Sample CollectionSubjects with clinically confirmed liver cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. |
| Stomach | – | Other: Blood Sample CollectionSubjects with clinically confirmed stomach cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. |
| Ovarian | – | Other: Blood Sample CollectionSubjects with clinically confirmed or suspicion of ovarian cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. |
| Esophageal | – | Other: Blood Sample CollectionSubjects with clinically confirmed esophageal cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 7500 subjects will be enrolled. Subjects will be men and women, 18 years of age and older, who have an untreated breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or esophageal cancer.
Key inclusion criteria (5 listed)
- Subject is male or female > 18 years of age.
- Subject has an untreated primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or esophageal cancer.
- OR
- Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, or ovarian cancer based on imaging.
- Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Key exclusion criteria (10 listed)
- Prior or concurrent cancer diagnosis defined as:
- Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
- Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection.
- Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
- Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
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 |
|---|---|---|
| Blood Sample CollectionSubjects participating in the study will have blood drawn at enrollment. | Other | Bladder, Breast, Colorectal, Esophageal, Kidney & Renal Pelvis, Liver, Lung, Ovarian, Pancreatic, Prostate, Stomach, Uterine |
Primary outcome
Biomarker Evaluation
Time frame: Point in time (one day) blood collection at enrollment
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with solid tumor cancers.
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 1 Sep 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol and informed consent form (when applicable) will also be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
119 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Lung Cancer, run by Exact Sciences Corporation at 119 sites in United States.
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 10 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 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 119 sites in United States. 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?
Biomarker Evaluation (time frame: Point in time (one day) blood collection at enrollment). 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 1 Sep 2022.