Soft Tissue SarcomaSAFETYNCT03944798
Surveillance AFter Extremity Tumor surgerY
A study testing Frequency: Every 3 Months, Frequency: Every 6 Months and Imaging Modality: Chest Radiograph (CXR) in people with Soft Tissue Sarcoma and Lung Metastases, run by McMaster University at 35 sites in 14 countries.
Trial summary
Following treatment for a primary extremity sarcoma, patients remain at risk for the development of local and systemic disease recurrence. Metastasis (distant recurrence) to the lung is the most frequent single location of disease recurrence in sarcoma patients, occurring in almost half of all patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma, Lung Metastases
- What is being tested?
- Frequency: Every 3 Months, Frequency: Every 6 Months and Imaging Modality: Chest Radiograph (CXR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 35 sitesin 14 countries
- Study dates
- 19 Nov 2019to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- The patient is 18 years of age or older;
- The patient has been diagnosed with a primary extremity grade II or III soft-tissue sarcoma (STS);
- The patient has undergone surgical excision of the tumor with curative intent and with no evidence of gross residual disease based on the pathology report;
- The patient has completed all planned neoadjuvant or adjuvant radiation and / or chemotherapy, if applicable;
- The tumor size is greater than or equal to (≥) five centimeters according to the pathology report or based on the pre-treatment MRI if neoadjuvant radiation and / or chemotherapy are given; and
- The patient provides informed consent.
Who cannot join
- The patient has metastases at initial presentation based on the radiology report of the initial thoracic imaging†;
- The patient has recently undergone surgical excision of a local recurrence;
- The patient has been diagnosed with one of the special sub-types, myxoid / round cell liposarcoma or extra-skeletal Ewing's sarcoma*;
- The patient has been previously diagnosed with a genetic syndrome with an elevated risk of malignancy, such as Li-Freumeni Syndrome‡;
- The patient has been previously diagnosed with a co-morbid condition that has a life expectancy of less than (<) one year;
- The site-specific surveillance protocol for the patient's disease is not compatible with the study protocol (i.e., regular planned whole-body imaging with positron emission tomography [PET] scans);
Show all 12Show fewer
- Likely problems, in the judgment of the investigator, with the patient maintaining follow-up (with the specific reasoning requiring approval of the Methods Center);
- The patient is currently enrolled in a study that does not permit co-enrolment; and
- The patient has already been enrolled in the SAFETY trial.
- A second CT scan may be required to confirm that indeterminate nodules are false positives before the patient can be enrolled (provided that the second CT scan shows no evidence of metastatic disease);
- Myxoid liposarcoma and extra-skeletal Ewing's sarcoma have different metastatic patterns, which necessitate different surveillance protocols;
- Individuals with Li-Freumeni Syndrome, or other genetic syndromes with an elevated risk of malignancy, appear to be at an elevated risk for radiation-induced cancers, so the use of CT scans should be limited.
Trial locations and contacts
35 sites in 14 countries.
35 sites in 14 countries
United States16 sites
Albany Medical Center
Albany, New York, 12208
UChicago Medicine
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Texas Tech Health Sciences Center
El Paso, Texas, 79905
Parkview Cancer Institute
Fort Wayne, Indiana, 46845
University of Florida Health Shands Hospital
Gainesville, Florida, 32608
Hartford HealthCare
Hartford, Connecticut, 06102
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Allegheny Health Network Research Institute
Monroeville, Pennsylvania, 15212
NYU Langone Orthopaedic Hospital/Perlmutter Cancer Center
New York, New York, 10010
Oregon Health and Science University Hospital
Portland, Oregon, 97239
University of California Davis Medical Center
Sacramento, California, 95817
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Montefiore Medical Center
The Bronx, New York, 10467
Canada7 sites
Nova Scotia Health
Halifax, Nova Scotia, B3H 3A7
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, L8V1C3
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
McGill University Health Centre
Montreal, Quebec, H4A 3J1
The Ottawa Hospital
Ottawa, Ontario
Hôtel Dieu du Quebec
Québec, Quebec, G1R 2J6
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
About this study
Official title: Surveillance AFter Extremity Tumor surgerY (SAFETY) International Randomized Controlled Trial
Following treatment for a primary extremity sarcoma, patients remain at risk for the development of local and systemic disease recurrence. Metastasis (distant recurrence) to the lung is the most frequent single location of disease recurrence in sarcoma patients, occurring in almost half of all patients. Therefore, careful post-operative surveillance is an integral element of patient care. However, the detection of metastases does not necessarily affect long-term survival and may negatively impact quality of life. Surveillance strategies have not been well researched and have been identified as the top research priority in the extremity sarcoma field. Using a 2X2 factorial design to maximize efficiency and reduce overall trial costs, the SAFETY trial randomized 310 extremity soft-tissue sarcoma (STS) patients to determine the effect of surveillance strategy on overall patient survival after surgery for a STS of the extremity by comparing the effectiveness of both surveillance frequency (every 3 vs. every 6 months) and imaging modality (CT scans vs. chest radiographs).
Read the detailed description
Post-treatment STS surveillance is an integral element of patient care. Although earlier detection of metastatic disease may improve long-term survival, no study has yet provided definitive evidence to support this assumption. A thorough systematic review of the literature has identified only a single limited randomized controlled trial (RCT) evaluating this clinical question, and surveys of sarcoma surgeons have determined that surgeons typically follow their patients based on the way in which they were trained. The orthopaedic oncology field has identified sarcoma surveillance strategy as the top research priority in the field. In order to fill the evidence gap in sarcoma surveillance, a large international RCT is required. The investigators, therefore, propose the Surveillance AFter Extremity Tumor surgerY (SAFETY) trial. In preparation for the SAFETY trial, the SAFETY investigators have completed the following preparatory work: A) establishment of a worldwide research collaborative group that spans 6 continents; B) collection of data from international sarcoma patients to determine their perceptions of sarcoma surveillance and their willingness to participate in a study in which randomization will determine their follow-up protocols; and C) the organization of a large Protocol Development Meeting with international and multidisciplinary participation, including sarcoma patient involvement, where critical aspects of the protocol were discussed and finalized.
The international, multi-center SAFETY trial will determine the effect of surveillance strategy on patient-important outcomes after surgery for a STS of the extremity by comparing the effectiveness of both surveillance frequency (every 3 vs. every 6 months) and imaging modality (CT scans vs. chest radiographs). Ultimately, the SAFETY trial will provide the necessary evidence to develop evidence-based surveillance guidelines, and is poised to have a significant impact on the post-operative care and outcomes of extremity STS patients.
- Conditions
- Soft Tissue Sarcoma, Lung Metastases
- Being tested
- Frequency: Every 3 Months, Frequency: Every 6 Months, Imaging Modality: Chest Radiograph (CXR), Imaging Modality: Chest CT
- Keywords
- Soft Tissue Sarcoma, Lung Metastases, Overall Survival, Surveillance, Randomized Controlled Trial, Patient Anxiety, Serious Adverse Events
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequency: Every 3 MonthsOther
every 3 months
Frequency: Every 6 MonthsOther
every 6 months
Imaging Modality: Chest Radiograph (CXR)Other
Chest radiograph (CXR)
Imaging Modality: Chest CTOther
Chest computed tomography (CT)
| Study group | Role | What they receive |
|---|---|---|
| Surveillance Arm I | Active comparator | Clinical assessment and chest radiograph (CXR) every six months for two years Receives: Other: Frequency: Every 6 Months; Other: Imaging Modality: Chest Radiograph (CXR) |
| Surveillance Arm II | Experimental | Clinical assessment and CXR every three months for two years Receives: Other: Frequency: Every 3 Months; Other: Imaging Modality: Chest Radiograph (CXR) |
| Surveillance Arm III | Experimental | Clinical assessment and chest computed tomography (CT) every six months for two years Receives: Other: Frequency: Every 6 Months; Other: Imaging Modality: Chest CT |
| Surveillance Arm IV | Experimental | Clinical assessment and chest CT every three months for two years Receives: Other: Frequency: Every 3 Months; Other: Imaging Modality: Chest CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchal Composite Outcome of Patient-Important Outcomes
The composite outcome consists of overall survival, serious adverse events, and patient-reported cancer-related anxiety
Measured: 3 years post randomization
Secondary outcomes (7)
Patient Anxiety
The PROMIS® Cancer-Anxiety instrument assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). The PROMIS® Cancer-Anxiety instrument is a computer adaptive test. A minimum of 4 questions must be answered. One's responses will guide the system's choice of the next question. The test will continue until either the standard error drops below a specified level or the participant has answered the maximum number of 12 questions (whichever comes first). Each question has 5 response options ranging in value from 1 to 5. To find the raw score, sum the values of the response to each question. The lowest possible raw score is 4 and the highest is 60. The raw score will then be converted into a standardized T-score for each participant using the applicable conversion table. A higher T-score represents a higher degree of anxiety.
Measured: 3 years
Patient Satisfaction
The PROMIS® Satisfaction with Social Roles \& Activities instrument assesses satisfaction with performing one's usual social roles and activities (e.g., 'I am satisfied with my ability to participate in family activities'). This instrument is a computer adaptive test. A minimum of 4 questions must be answered. One's response will guide the system's choice of the next question. The test will continue until either the standard error drops below a specified level or the participant has answered the maximum number of 12 questions (whichever comes first). Each question has 5 response options ranging in value from 1 to 5. To find the raw score, sum the values of the response to each question. The lowest possible raw score is 4 and the highest possible raw score is 60. The raw score will then be converted into a standardized T-score for each participant using the applicable conversion table. A higher T-score represents a higher degree of satisfaction.
Measured: 3 years
Patient Quality-of-Life
The validated EuroQol-5 Dimension 5-level (EQ-5D-5L) questionnaire measures generic health status and consists of 2 sections: the descriptive system and the Visual Analogue Scale (VAS). The descriptive system is comprised of 5 dimensions (mobility, self care, usual activities, pain / discomfort and anxiety / depression). Each question has 5 response options ranging in value from 1 to 5. To find the raw score, sum the values of the response to each question. The lowest possible raw score is 5 and the highest is 25. A lower raw score in the descriptive system represents fewer issues with each of the 5 domains. The VAS records a participant's self-rated health from 0 to 100 on a vertical VAS with endpoints labeled '100 - the best health you can imagine' and '0 - the worst health you can imagine'. The participant is asked to mark an 'X' on the scale and write the corresponding number, which is this section's raw score.
Measured: 3 years
Local Recurrence-Free Survival
As measured by the length of time from the time of randomization that the participant survives with no detection of recurrent disease at the initial tumor site or operative field.
Measured: 3 years
Metastasis-Free Survival
As measured by the length of time from the time of randomization that the participant survives with no detection of systemic disease recurrence at any anatomic location.
Measured: 3 years
Treatment-Related Complications
Will include both chemotherapy-related complications, such as febrile neutropenia, fungal infections or sepsis, and thoracotomy-related complications, such as pneumothorax, or surgical site infections.
Measured: 3 years
Net Healthcare Costs
Will include both the net costs of surveillance and costs incurred from metastasis treatment and metastasis treatment-related complications.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start19 Nov 2019
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue SarcomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 x 2 factorial superiority randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization, Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR), American Academy of Orthopaedic Surgeons, Musculoskeletal Tumor Society
- Responsible party
- Sponsor
- Investigators
- Michelle Ghert, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944798
- Sponsor's protocol ID
- GHRT02
- Acronym
- SAFETY
- Status last verified
- Nov 2024
- First submitted
- 7 May 2019
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
SAFETY Investigators. The Surveillance After Extremity Tumor Surgery (SAFETY) trial: protocol for a pilot study to determine the feasibility of a multi-centre randomised controlled trial. BMJ Open. 2019 Sep 18;9(9):e029054. doi: 10.1136/bmjopen-2019-029054.
PubMed 31537562
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance AFter Extremity Tumor surgerY (SAFETY) International Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03944798
- Acronym / sponsor ID
- SAFETY / GHRT02
- Conditions
- Soft Tissue Sarcoma, Lung Metastases
- Keywords
- Soft Tissue Sarcoma, Lung Metastases, Overall Survival, Surveillance, Randomized Controlled Trial, Patient Anxiety, Serious Adverse Events
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 310 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization, Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR), American Academy of Orthopaedic Surgeons, Musculoskeletal Tumor Society
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 May 2019 (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.
Following treatment for a primary extremity sarcoma, patients remain at risk for the development of local and systemic disease recurrence. Metastasis (distant recurrence) to the lung is the most frequent single location of disease recurrence in sarcoma patients, occurring in almost half of all patients. Therefore, careful post-operative surveillance is an integral element of patient care. However, the detection of metastases does not necessarily affect long-term survival and may negatively impact quality of life. Surveillance strategies have not been well researched and have been identified as the top research priority in the extremity sarcoma field. Using a 2X2 factorial design to maximize efficiency and reduce overall trial costs, the SAFETY trial randomized 310 extremity soft-tissue sarcoma (STS) patients to determine the effect of surveillance strategy on overall patient survival after surgery for a STS of the extremity by comparing the effectiveness of both surveillance frequency (every 3 vs. every 6 months) and imaging modality (CT scans vs. chest radiographs).
Detailed description
Post-treatment STS surveillance is an integral element of patient care. Although earlier detection of metastatic disease may improve long-term survival, no study has yet provided definitive evidence to support this assumption. A thorough systematic review of the literature has identified only a single limited randomized controlled trial (RCT) evaluating this clinical question, and surveys of sarcoma surgeons have determined that surgeons typically follow their patients based on the way in which they were trained. The orthopaedic oncology field has identified sarcoma surveillance strategy as the top research priority in the field. In order to fill the evidence gap in sarcoma surveillance, a large international RCT is required. The investigators, therefore, propose the Surveillance AFter Extremity Tumor surgerY (SAFETY) trial. In preparation for the SAFETY trial, the SAFETY investigators have completed the following preparatory work: A) establishment of a worldwide research collaborative group that spans 6 continents; B) collection of data from international sarcoma patients to determine their perceptions of sarcoma surveillance and their willingness to participate in a study in which randomization will determine their follow-up protocols; and C) the organization of a large Protocol Development Meeting with international and multidisciplinary participation, including sarcoma patient involvement, where critical aspects of the protocol were discussed and finalized.
The international, multi-center SAFETY trial will determine the effect of surveillance strategy on patient-important outcomes after surgery for a STS of the extremity by comparing the effectiveness of both surveillance frequency (every 3 vs. every 6 months) and imaging modality (CT scans vs. chest radiographs). Ultimately, the SAFETY trial will provide the necessary evidence to develop evidence-based surveillance guidelines, and is poised to have a significant impact on the post-operative care and outcomes of extremity STS patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 2 x 2 factorial superiority randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Surveillance Arm I | Active comparator | Other: Frequency: Every 6 Months, Other: Imaging Modality: Chest Radiograph (CXR)Clinical assessment and chest radiograph (CXR) every six months for two years |
| Surveillance Arm II | Experimental | Other: Frequency: Every 3 Months, Other: Imaging Modality: Chest Radiograph (CXR)Clinical assessment and CXR every three months for two years |
| Surveillance Arm III | Experimental | Other: Frequency: Every 6 Months, Other: Imaging Modality: Chest CTClinical assessment and chest computed tomography (CT) every six months for two years |
| Surveillance Arm IV | Experimental | Other: Frequency: Every 3 Months, Other: Imaging Modality: Chest CTClinical assessment and chest CT every three months for two years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient is 18 years of age or older;
- The patient has been diagnosed with a primary extremity grade II or III soft-tissue sarcoma (STS);
- The patient has undergone surgical excision of the tumor with curative intent and with no evidence of gross residual disease based on the pathology report;
- The patient has completed all planned neoadjuvant or adjuvant radiation and / or chemotherapy, if applicable;
- The tumor size is greater than or equal to (≥) five centimeters according to the pathology report or based on the pre-treatment MRI if neoadjuvant radiation and / or chemotherapy are given; and
Key exclusion criteria (12 listed)
- The patient has metastases at initial presentation based on the radiology report of the initial thoracic imaging†;
- The patient has recently undergone surgical excision of a local recurrence;
- The patient has been diagnosed with one of the special sub-types, myxoid / round cell liposarcoma or extra-skeletal Ewing's sarcoma*;
- The patient has been previously diagnosed with a genetic syndrome with an elevated risk of malignancy, such as Li-Freumeni Syndrome‡;
- The patient has been previously diagnosed with a co-morbid condition that has a life expectancy of less than (<) one year;
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 |
|---|---|---|
| Frequency: Every 3 Monthsevery 3 months | Other | Surveillance Arm II, Surveillance Arm IV |
| Frequency: Every 6 Monthsevery 6 months | Other | Surveillance Arm I, Surveillance Arm III |
| Imaging Modality: Chest Radiograph (CXR)Chest radiograph (CXR) | Other | Surveillance Arm I, Surveillance Arm II |
| Imaging Modality: Chest CTChest computed tomography (CT) | Other | Surveillance Arm III, Surveillance Arm IV |
Primary outcome
Hierarchal Composite Outcome of Patient-Important Outcomes
Time frame: 3 years post randomization
The composite outcome consists of overall survival, serious adverse events, and patient-reported cancer-related anxiety
7 secondary outcomes
Patient Anxiety
Time frame: 3 years
Patient Satisfaction
Time frame: 3 years
Patient Quality-of-Life
Time frame: 3 years
Local Recurrence-Free Survival
Time frame: 3 years
Metastasis-Free Survival
Time frame: 3 years
Treatment-Related Complications
Time frame: 3 years
Net Healthcare Costs
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Derived from this study: PubMed 31537562SAFETY Investigators. The Surveillance After Extremity Tumor Surgery (SAFETY) trial: protocol for a pilot study to determine the feasibility of a multi-centre randomised controlled trial. BMJ Open. 2019 Sep 18;9(9):e029054. doi: 10.1136/bmjopen-2019-029054.
- Optimal surveillance strategies following curative surgery for extremity sarcoma: A systematic review of Randomized Control Trials \[published in pre-print\].Link provided by the sponsor.
- Surveillance AFter Extremity Tumor surgerY (SAFETY): A Protocol for an International Randomized Controlled Trial \[published in pre-print\].Link provided by the sponsor.
- The Surveillance After Extremity Tumor Surgery (SAFETY) Pilot International Multi-Center Randomized Controlled TrialLink provided by the sponsor.
- 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.
Michelle Ghert, MD principal investigator
McMaster University
35 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frequency: Every 3 Months, Frequency: Every 6 Months and Imaging Modality: Chest Radiograph (CXR) in people with Soft Tissue Sarcoma and Lung Metastases, run by McMaster University at 35 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Canada, Argentina, Australia, Austria and 9 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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?
Hierarchal Composite Outcome of Patient-Important Outcomes (time frame: 3 years post randomization). 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 NCT03944798, which also lists 1 linked publication.
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 Nov 2024.