SarcomaNCT03959033
Patient Reported Outcome Measures (PROMs) With Trabectedin
An observational study of Sarcoma and Liposarcoma, run by University of Leeds at 1 site in United Kingdom.
Trial summary
Patient reported outcome measures (PROMs) are central to understanding the impact of cancer treatments on patients. Treatment may control cancer growth, and even sometimes modestly improve the length of life, but at the expense of disruption of lifestyle, and of toxicities. Read more about this study
- Who is it for?
- Ages 16 to 130 years
- Conditions the study is for
- Sarcoma, Liposarcoma, Leiomyosarcoma
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Nov 2016to 28 Aug 2019
- 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 16 to 130 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will identify adult patients treated in Leeds with an indication for Trabectedin as either second or third line therapy for relapsed soft tissue sarcoma. Patients suitable for treatment will be those with the following histologies Synovial Sarcoma Myxoid liposarcomas De-differentiated liposarcoma with some clinical sensitivity demonstrated to earlier lines of chemotherapy Leiomyosarcoma Other soft-tissue sarcomas with some clinical sensitivity demonstrated to earlier lines of chemotherapy
Who may be able to join
- This study will include adult patients treated in Leeds with an indication for Trabectedin as either second or third line therapy for relapsed soft tissue sarcoma.
- Patients will have the ability to provide informed consent and they will have adequate literacy in reading English, or complete the instrument using an NHS interpreter.
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS9 7TF
About this study
Official title: A Pilot Study of Patient Reported Outcomes When Treated With Trabectedin for Unresectable and/or Metastatic Soft Tissue Sarcoma
Patient reported outcome measures (PROMs) are central to understanding the impact of cancer treatments on patients. Treatment may control cancer growth, and even sometimes modestly improve the length of life, but at the expense of disruption of lifestyle, and of toxicities. It is very important to use PROMs to evaluate the balance between these risks and benefits to understand the overall impact of the treatment.
It remains poorly described whether patients report improved outcomes during palliative chemotherapy with trabectedin, using high quality questionnaires, and how this may vary with the clinical effects and duration of the treatment and characteristics of the patient.
Read the detailed description
Trabectedin improves progression-free survival in un-resectable advanced soft tissue sarcoma, in particular lipo- and leiomyo- sarcomas after failure of conventional chemotherapy, with a low level of reported grade 3 symptomatic toxicity for many patients. However objective responses are infrequent, with the largest proportion of patients who benefit using traditional oncological response criteria having a delay in progression with the cancer stable. Trabectedin may improve the duration of cancer control by the modulation of cancer growth as measured by the growth modulation index (GMI).
Patient reported outcome measures (PROMs) are central to understanding the impact of cancer therapies which may shrink cancers or control their growth, and even sometimes modestly improve the length of life, but at the expense of disruption of lifestyle, and of toxicities.
It is very important to use PROMs to evaluate the balance between these risks and benefits to understand the overall impact of the therapy. It remains poorly described whether patients report improved outcomes during palliative chemotherapy with trabectedin, using validated questionnaires, and how this may vary with the clinical efficacy and duration of the treatment and the demographic and clinical characteristics of the patient. Therefore the investigators intend to examine the feasibility of collecting patient reported outcome measures using validated instruments prospectively during English NHS administration of Trabectedin and with this to explore the pattern of patient reported outcomes, such as is the trajectory in PROMs distinct comparing groups by the size or symptoms from tumour masses.
The study will aim deliver Patient Reported Outcomes Measures (PROMs) data in patients with advanced tissue sarcoma. The recruitment target is a total of 30 patients over a 2 year period. Patients' quality of life (QoL) will be captured using a validated QoL questionnaire (EORTC QLQ-C30) during their treatment with Trabectedin. The questionnaire takes approximately 12 minutes and the patient will complete this unaided. Patients will be required to complete the electronic questionnaire using Q-Tool. Q-Tool is a web-based piece of software. Patients will be required to complete this questionnaire alongside receiving standard of care treatment with Trabectedin in the following pattern: On the day of administration of the 1st of treatment with Trabectedin; before the 2nd treatment of Trabectedin; before the 4th treatment of Trabectedin; prior to the 7th treatment of Trabectedin; prior to the 10th treatment of Trabectedin and then will continue in 3 weekly cycles until the end of treatment with Trabectedin. Patients will complete the questionnaire on the computer terminals available in the outpatient clinic before they see the doctor and nurses and prior to treatment on each of these days.
Patients at the end of treatment with Trabectedin will complete a short exit questionnaire. This will assess their experiences of completing the QoL questionnaire and ease of using Q-Tool. The exit questionnaire will take approximately 5 minutes to complete. This will be completed in the outpatient area and provided to the patient by the Research Nurse.
- Conditions
- Sarcoma, Liposarcoma, Leiomyosarcoma
- Keywords
- PROMs, EORTC QLQc-30
- Medical subject headings
- Sarcoma, Liposarcoma, Leiomyosarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global quality of life using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire core 30 from baseline (week 1) through to 12 weeks (to day 1 of cycle 4 of trabectedin).
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100.
Measured: Through to study completion, an average of 12 weeks
What is the trajectory in the subscales and symptom scales in the scale, from baseline (day 1 cycle 1) to day 1 cycle 4, day 1 cycle 7 and day 1 cycle 10 etc of Trabectedin?
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100.
Measured: Through to study completion, an average of 12 weeks
What is the association between patient's prior treatment (second line versus third line) and the trajectory of the subscales and symptom scales in the EORTC QLQc30 ?
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100.
Measured: Through to study completion, an average of 12 weeks
What is the association between patient age (in deciles) and the trajectory of the subscales and symptom scales in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 scale?
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100.
Measured: Through to study completion, an average of 12 weeks
What is the relationship between the trajectory of responses in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 scale and the growth modulation index?
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100.
Measured: Through to study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start29 Nov 2016
- Primary completion28 Aug 2019
- Study completion28 Aug 2019
Why it stopped: Insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Stark, University of Leeds
- Investigators
- Daniel Stark, Principal investigator, University of LeedsDaniel Stark, Principal investigator, d.p.stark@leeds.ac.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959033
- Sponsor's protocol ID
- 16/WM/0446
- Status last verified
- Aug 2022
- First submitted
- 12 Jan 2018
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Patient Reported Outcomes When Treated With Trabectedin for Unresectable and/or Metastatic Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT03959033
- Acronym / sponsor ID
- 16/WM/0446
- Conditions
- Sarcoma, Liposarcoma, Leiomyosarcoma
- Keywords
- PROMs, EORTC QLQc-30
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 22 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.
Patient reported outcome measures (PROMs) are central to understanding the impact of cancer treatments on patients. Treatment may control cancer growth, and even sometimes modestly improve the length of life, but at the expense of disruption of lifestyle, and of toxicities. It is very important to use PROMs to evaluate the balance between these risks and benefits to understand the overall impact of the treatment.
It remains poorly described whether patients report improved outcomes during palliative chemotherapy with trabectedin, using high quality questionnaires, and how this may vary with the clinical effects and duration of the treatment and characteristics of the patient.
Detailed description
Trabectedin improves progression-free survival in un-resectable advanced soft tissue sarcoma, in particular lipo- and leiomyo- sarcomas after failure of conventional chemotherapy, with a low level of reported grade 3 symptomatic toxicity for many patients. However objective responses are infrequent, with the largest proportion of patients who benefit using traditional oncological response criteria having a delay in progression with the cancer stable. Trabectedin may improve the duration of cancer control by the modulation of cancer growth as measured by the growth modulation index (GMI).
Patient reported outcome measures (PROMs) are central to understanding the impact of cancer therapies which may shrink cancers or control their growth, and even sometimes modestly improve the length of life, but at the expense of disruption of lifestyle, and of toxicities.
It is very important to use PROMs to evaluate the balance between these risks and benefits to understand the overall impact of the therapy. It remains poorly described whether patients report improved outcomes during palliative chemotherapy with trabectedin, using validated questionnaires, and how this may vary with the clinical efficacy and duration of the treatment and the demographic and clinical characteristics of the patient. Therefore the investigators intend to examine the feasibility of collecting patient reported outcome measures using validated instruments prospectively during English NHS administration of Trabectedin and with this to explore the pattern of patient reported outcomes, such as is the trajectory in PROMs distinct comparing groups by the size or symptoms from tumour masses.
The study will aim deliver Patient Reported Outcomes Measures (PROMs) data in patients with advanced tissue sarcoma. The recruitment target is a total of 30 patients over a 2 year period. Patients' quality of life (QoL) will be captured using a validated QoL questionnaire (EORTC QLQ-C30) during their treatment with Trabectedin. The questionnaire takes approximately 12 minutes and the patient will complete this unaided. Patients will be required to complete the electronic questionnaire using Q-Tool. Q-Tool is a web-based piece of software. Patients will be required to complete this questionnaire alongside receiving standard of care treatment with Trabectedin in the following pattern: On the day of administration of the 1st of treatment with Trabectedin; before the 2nd treatment of Trabectedin; before the 4th treatment of Trabectedin; prior to the 7th treatment of Trabectedin; prior to the 10th treatment of Trabectedin and then will continue in 3 weekly cycles until the end of treatment with Trabectedin. Patients will complete the questionnaire on the computer terminals available in the outpatient clinic before they see the doctor and nurses and prior to treatment on each of these days.
Patients at the end of treatment with Trabectedin will complete a short exit questionnaire. This will assess their experiences of completing the QoL questionnaire and ease of using Q-Tool. The exit questionnaire will take approximately 5 minutes to complete. This will be completed in the outpatient area and provided to the patient by the Research Nurse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will identify adult patients treated in Leeds with an indication for Trabectedin as either second or third line therapy for relapsed soft tissue sarcoma. Patients suitable for treatment will be those with the following histologies Synovial Sarcoma Myxoid liposarcomas De-differentiated liposarcoma with some clinical sensitivity demonstrated to earlier lines of chemotherapy Leiomyosarcoma Other soft-tissue sarcomas with some clinical sensitivity demonstrated to earlier lines of chemotherapy
Key inclusion criteria (2 listed)
- This study will include adult patients treated in Leeds with an indication for Trabectedin as either second or third line therapy for relapsed soft tissue sarcoma.
- Patients will have the ability to provide informed consent and they will have adequate literacy in reading English, or complete the instrument using an NHS interpreter.
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Global quality of life using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire core 30 from baseline (week 1) through to 12 weeks (to day 1 of cycle 4 of trabectedin).
Time frame: Through to study completion, an average of 12 weeks
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100.
What is the trajectory in the subscales and symptom scales in the scale, from baseline (day 1 cycle 1) to day 1 cycle 4, day 1 cycle 7 and day 1 cycle 10 etc of Trabectedin?
Time frame: Through to study completion, an average of 12 weeks
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100.
What is the association between patient's prior treatment (second line versus third line) and the trajectory of the subscales and symptom scales in the EORTC QLQc30 ?
Time frame: Through to study completion, an average of 12 weeks
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100.
What is the association between patient age (in deciles) and the trajectory of the subscales and symptom scales in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 scale?
Time frame: Through to study completion, an average of 12 weeks
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100.
What is the relationship between the trajectory of responses in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 scale and the growth modulation index?
Time frame: Through to study completion, an average of 12 weeks
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100.
Results and safety
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- 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.
Daniel Stark principal investigator
University of Leeds
Daniel Stark principal investigator
d.p.stark@leeds.ac.uk
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 Sarcoma and Liposarcoma, run by University of Leeds at 1 site in United Kingdom.
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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 31 Aug 2022. 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 United Kingdom. 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 was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
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?
Change in Global quality of life using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire core 30 from baseline (week 1) through to 12 weeks (to day 1 of cycle 4 of trabectedin). (time frame: Through to study completion, an average of 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.