Oesophageal CancerSOURCENCT04232735
Evidence Based Information Provision to Improve Decision Making After Oesophagogastric Cancer Diagnosis (SOURCE)
A study testing Tool and training in people with Oesophageal Cancer and Gastric Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 12 sites in Netherlands.
Trial summary
The overarching aim of the programme 'Stimulating evidence based, personalized and tailored information provision to improve decision making after oesophagogastric cancer diagnosis' (SOURCE) is to provide oesophagogastric cancer patients at all disease stages with evidence based and personalized information about… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophageal Cancer, Gastric Cancer
- What is being tested?
- Tool and training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 12 sitesNetherlands
- Study dates
- 13 Oct 2020to 30 Sep 2023
- Phase
- Interventional
- 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
Who may be able to join
- Health care providers:
- Specialist, physician assistant or nurse practitioner in the field of oncology, oncological radiotherapy or oncological surgery who are used to discussing treatment and treatment outcome with patients
- Informed consent for data collection
- Three audiorecorded treatment information consultations with oesophageal or gastric cancer patients before the scheduled transition period (control measurements)
- Three audiorecorded treatment information consultations with oesophageal or gastric cancer patients after the scheduled transition period (intervention measurements) and before the scheduled end date of the study
- Patients:
Show all 9Show fewer
- Age ≥ 18 years
- Histological or cytological proof of oesophageal or gastric cancer
- Informed consent for trial data collection A treatment information consultation with a participating doctor to discuss either curative treatment, first line palliative treatment, and/or best supportive care.
Who cannot join
- Health care providers:
- Less than two control and/or intervention measurements
- Patients:
- Cognitive impairment or insufficient understanding of the Dutch language
- GIST and smallcell carcinomas.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Netherlands12 sites, 12 recruiting
- Recruiting
Flevoziekenhuis
Almere Stad
Loïs F van de Water, MSc.
- Recruiting
Academic Medical Center
Amsterdam, North Holland, 1105AZ
Loïs F van de Water, MSc., +31205665955, l.f.vandewater@amsterdamumc.nl
Hanneke WM van Laarhoven, MD, PhD
- Recruiting
VUmc
Amsterdam
Loïs F van de Water, MSc.
- Not yet recruiting
Radiotherapiegroep
Arnhem
Loïs F van de Water, MSc.
- Not yet recruiting
Rijnstate
Arnhem
Loïs F van de Water, MSc.
- Not yet recruiting
Catherina Ziekenhuis
Eindhoven
Loïs F van de Water, MSc.
- Not yet recruiting
LUMC
Leiden
Loïs F. van de Water, MSc.
- Not yet recruiting
Maastro
Maastricht
Loïs F van de Water, MSc.
- Not yet recruiting
Radboud UMC
Nijmegen
Loïs F van de Water, MSc.
- Not yet recruiting
BVI
Tilburg
Loïs F van de Water, MSc.
- Not yet recruiting
ETZ
Tilburg
Loïs F van de Water, MSc.
- Not yet recruiting
UMC Utrecht
Utrecht
Loïs F. van de Water, MSc.
About this study
Official title: Stimulating Evidence Based, Personalized and Tailored Information Provision to Improve Decision Making After Oesophagogastric CancEr Diagnosis - a Pragmatic Stepped Wedge Trial-
The overarching aim of the programme 'Stimulating evidence based, personalized and tailored information provision to improve decision making after oesophagogastric cancer diagnosis' (SOURCE) is to provide oesophagogastric cancer patients at all disease stages with evidence based and personalized information about survival, treatment-related side-effects and/or complications and health related quality of life, tailored to patients' specific information needs, to facilitate informed decision making about treatment and thereby optimize personal care and outcomes.
For this purpose the Source tool and training were designed. The Source tool is a prediction model based website to be used by care givers for informing patients about the outcomes of treatment. The Source training for care givers is designed to learn care givers how to inform patients effectively, especially about the outcomes of treatment.
Read the detailed description
The overarching aim of the programme 'Stimulating evidence based, personalized and tailored information provision to improve decision making after oesophagogastric cancer diagnosis' (SOURCE) is to provide oesophagogastric cancer patients at all disease stages with evidence based and personalized information about survival, treatment-related side-effects and/or complications and health related quality of life, tailored to patients' specific information needs, to facilitate informed decision making about treatment and thereby optimize personal care and outcomes.
For this purpose the Source tool and training were designed. The Source tool is a prediction model based website to be used by care givers for informing patients about the outcomes of treatment. The Source training for care givers is designed to learn care givers how to inform patients effectively, especially about the outcomes of treatment.
The primary aim of the SOURCE trial is to investigate the effect of the tool and training on the (numerical) precision of information about outcomes of treatment in the treatment information consultation. Secondary outcomes include: patients' satisfaction, evaluation and knowledge of the information provided by the health care provider, evaluation of the decision made and health related quality of life.
A pragmatic stepped wedge design will be used to test the effect of intervention. 21 health care providers will include 3 patients as control measurements (before intervention) and 3 patients as intervention measurements (after intervention). Participating centers will be divided into geographical subgroups, in which the transition period (in which the intervention will take place) will be spread across time.
All oesophageal and gastric cancer patients scheduled for a treatment information consultation with a participating health care provider are suitable for inclusion and will be approached for participation in the SOURCE study. Measurements include audio recordings of the treatment information consultation and questionnaires filled in by patients and health care providers at different moments in time. Audio recordings will be scored and analyzed based on a study specific coding scheme.
The investigators estimate the physical burden/risk of this study to be negligible.
- Conditions
- Oesophageal Cancer, Gastric Cancer
- Being tested
- Tool and training
- Keywords
- Prediction models, Tailored information, Stepped Wedge Trial, Oesophageal cancer, Gastric cancer, Webtool, Health care provider training
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tool and trainingOther
The Source tool aims to assist health care providers with giving evidence based information about treatment outcomes by providing visualizations of personalized predictions of treatment outcomes for different treatments of oesophageal and gastric cancer. These predictions result from recently designed and updated prediction models on the survival, toxicity, complications and health related quality of life of oesophageal and gastric cancer patients.
The training aims to teach participants to inform patients about outcomes of treatment. The training is placed in the context of shared decision making (SDM), following the 4-step model by Stiggelbout et al., 2015.8 The training is provided in small groups (3-6 participants) by an experienced trainer and supported by professional actors. The training aims to address knowledge, attitude and skills.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The Source tool is used by care givers for informing patients about the outcomes of treatment. Prediction models are developed and built in the website in order to generate a personalized prediction of the outcomes: survival, toxicity and/or complications and HRQL. These predictions are visualized in clear and comprehensible graphs with a broad variation of options available for tailoring of the visualizations.
In order for care givers to be able to use this tool effectively, we designed the Source training. This communication skills training is comprised of an e-learning, two face-to-face group sessions and an individual booster session. Aside from an instruction video on the navigation within the Source tool, the e-learning consists of theory and tips and tricks on how to inform patients and communicate risks. The face-to-face components of the training are focused on getting the skilled use of the source tool into practice, by receiving personal feedback on the performance. Receives: Other: Tool and training |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOURCE observational scale
The SOURCE observational scale is developed to primary answer the following question: Does the combination of the tool and the training improve observed (numerical) precision of information about treatment outcomes in clinical consultations? Min. value: 1 Max. value:4 Higher scores mean higher (numerical) precision
Measured: through study completion, an average of 1 year
Secondary outcomes (18)
Continuing professional development (CPD) reaction Questionnaire
Health care providers' intention to inform patients about treatment outcomes using numbers (effect training only)
Measured: through study completion, an average of 1 year
Patient Satisfaction Questionnaire (PSQ-5 patient and doctor version)
Patient and physician satisfaction with communication and decision making
Measured: 2 weeks
Shared Decision Making Questionnaire (SDMQ-9)
Patient-reported shared decision making
Measured: 2 weeks
Decisional Conflict Scale (DCS)
Patients' evaluation of the decision made
Measured: 2 weeks
EORTC QLQ - INFO25 + tailor made items on treatment outcome information
Patients' evaluation and knowledge of the information provided by the health care provider
Measured: 2 weeks
EORTC QLQ-C30
Patients' health related quality of life, cancer specific
Measured: 3 months vs. baseline
EORTC QLQ-OG25
Patients' health related quality of life, gastro-intestinal cancer specific
Measured: 3 months vs. baseline
Trust in the Oncologist Scale (TiOS-sf)
Patients' trust in the health care provider
Measured: 2 weeks
State-Trait Anxiety Inventory (STAI)
Patients' anxiety
Measured: 2 weeks vs. baseline
((Mini-)Mental Adjustment to Cancer scale ((Mini-)MAC)
Patients' helplessness/hopelessness + fighting spirit
Measured: 2 weeks vs. baseline
Duration of consultation in minutes (min.)
Consultation time
Measured: through study completion, an average of 1 year
Health care providers' personalization of treatment outcome information measured with SOURCE observational scale
Frequency of explicitly personalizing treatment outcome information, based on audio tapes Min. value: 0 Max. value: endless Higher values mean more utterances of personalization
Measured: through study completion, an average of 1 year
Health care providers' tailoring of treatment outcome information measured with SOURCE observational scale
Frequency of explicitly tailoring treatment outcome information, based on audio tapes Min. value: 0 Max. value: endless Higher values mean more utterances of tailoring
Measured: through study completion, an average of 1 year
Health care providers' use of visualizations of treatment outcome information measured with SOURCE observational scale
Frequency of explicitly showing visualizations treatment outcome information, based on audio tapes Min. value: 0 Max. value: endless Higher values mean more utterances of showing visualizations
Measured: through study completion, an average of 1 year
Health care providers' use of time frames when giving treatment outcome information measured with SOURCE observational scale
Presence of time frame when giving treatment outcome information, in utterances coded for the primary outcome Min. value: 0 Max. value: 1 Value 1 means time frame present, value 0 means time frame absent
Measured: through study completion, an average of 1 year
Treatment outcome category of health care providers' treatment outcome information measured with SOURCE observational scale
Treatment outcome category of health care providers' treatment outcome information, in utterances coded for the primary outcome Values: Survival, Health-related Quality of Life, Side effects and complications, Progression of tumor Non-ordinal variable
Measured: through study completion, an average of 1 year
Person initializing treatment outcome information measured with SOURCE observational scale
Person taking the initaitive for the health care provider's treatment outcome information, in utterances coded for the primary outcome Values: Health care provider, Patient Non-ordinal variable
Measured: through study completion, an average of 1 year
Health care providers' (numerical) precision of treatment outcome information measured with SOURCE observational scale simulated patient consultations (effect intervention)
Health care providers' (numerical) precision of treatment outcome information measured in simulated patient consultations (effect intervention) Min. value: 1 Max. value:4 Higher scores mean higher (numerical) precision
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start13 Oct 2020
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pragmatic Stepped Wedge Design
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Principal investigator, H.W.M. van Laarhoven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- H WM van Laarhoven, Prof. Dr., Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232735
- Sponsor's protocol ID
- W19_094#19.124
- Acronym
- SOURCE
- Status last verified
- Dec 2022
- First submitted
- 20 Dec 2019
- Last updated
- 16 Dec 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 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulating Evidence Based, Personalized and Tailored Information Provision to Improve Decision Making After Oesophagogastric CancEr Diagnosis - a Pragmatic Stepped Wedge Trial-
- ClinicalTrials.gov ID
- NCT04232735
- Acronym / sponsor ID
- SOURCE / W19_094#19.124
- Conditions
- Oesophageal Cancer, Gastric Cancer
- Keywords
- Prediction models, Tailored information, Stepped Wedge Trial, Oesophageal cancer, Gastric cancer, Webtool, Health care provider training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 18 Jan 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 overarching aim of the programme 'Stimulating evidence based, personalized and tailored information provision to improve decision making after oesophagogastric cancer diagnosis' (SOURCE) is to provide oesophagogastric cancer patients at all disease stages with evidence based and personalized information about survival, treatment-related side-effects and/or complications and health related quality of life, tailored to patients' specific information needs, to facilitate informed decision making about treatment and thereby optimize personal care and outcomes.
For this purpose the Source tool and training were designed. The Source tool is a prediction model based website to be used by care givers for informing patients about the outcomes of treatment. The Source training for care givers is designed to learn care givers how to inform patients effectively, especially about the outcomes of treatment.
Detailed description
The overarching aim of the programme 'Stimulating evidence based, personalized and tailored information provision to improve decision making after oesophagogastric cancer diagnosis' (SOURCE) is to provide oesophagogastric cancer patients at all disease stages with evidence based and personalized information about survival, treatment-related side-effects and/or complications and health related quality of life, tailored to patients' specific information needs, to facilitate informed decision making about treatment and thereby optimize personal care and outcomes.
For this purpose the Source tool and training were designed. The Source tool is a prediction model based website to be used by care givers for informing patients about the outcomes of treatment. The Source training for care givers is designed to learn care givers how to inform patients effectively, especially about the outcomes of treatment.
The primary aim of the SOURCE trial is to investigate the effect of the tool and training on the (numerical) precision of information about outcomes of treatment in the treatment information consultation. Secondary outcomes include: patients' satisfaction, evaluation and knowledge of the information provided by the health care provider, evaluation of the decision made and health related quality of life.
A pragmatic stepped wedge design will be used to test the effect of intervention. 21 health care providers will include 3 patients as control measurements (before intervention) and 3 patients as intervention measurements (after intervention). Participating centers will be divided into geographical subgroups, in which the transition period (in which the intervention will take place) will be spread across time.
All oesophageal and gastric cancer patients scheduled for a treatment information consultation with a participating health care provider are suitable for inclusion and will be approached for participation in the SOURCE study. Measurements include audio recordings of the treatment information consultation and questionnaires filled in by patients and health care providers at different moments in time. Audio recordings will be scored and analyzed based on a study specific coding scheme.
The investigators estimate the physical burden/risk of this study to be negligible.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pragmatic Stepped Wedge Design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Tool and trainingThe Source tool is used by care givers for informing patients about the outcomes of treatment. Prediction models are developed and built in the website in order to generate a personalized prediction of the outcomes: survival, toxicity and/or complications and HRQL. These predictions are visualized in clear and comprehensible graphs with a broad variation of options available for tailoring of the visualizations. In order for care givers to be able to use this tool effectively, we designed the Source training. This communication skills training is comprised of an e-learning, two face-to-face group sessions and an individual booster session. Aside from an instruction video on the navigation within the Source tool, the e-learning consists of theory and tips and tricks on how to inform patients and communicate risks. The face-to-face components of the training are focused on getting the skilled use of the source tool into practice, by receiving personal feedback on the performance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Specialist, physician assistant or nurse practitioner in the field of oncology, oncological radiotherapy or oncological surgery who are used to discussing treatment and treatment outcome with patients
- Informed consent for data collection
- Three audiorecorded treatment information consultations with oesophageal or gastric cancer patients before the scheduled transition period (control measurements)
- Three audiorecorded treatment information consultations with oesophageal or gastric cancer patients after the scheduled transition period (intervention measurements) and before the scheduled end date of the study
- Age ≥ 18 years
Key exclusion criteria (5 listed)
- Less than two control and/or intervention measurements
- Cognitive impairment or insufficient understanding of the Dutch language
- GIST and smallcell carcinomas.
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 |
|---|---|---|
| Tool and trainingThe Source tool aims to assist health care providers with giving evidence based information about treatment outcomes by providing visualizations of personalized predictions of treatment outcomes for different treatments of oesophageal and gastric cancer. These predictions result from recently designed and updated prediction models on the survival, toxicity, complications and health related quality of life of oesophageal and gastric cancer patients. The training aims to teach participants to inform patients about outcomes of treatment. The training is placed in the context of shared decision making (SDM), following the 4-step model by Stiggelbout et al., 2015.8 The training is provided in small groups (3-6 participants) by an experienced trainer and supported by professional actors. The training aims to address knowledge, attitude and skills. | Other | Intervention |
Primary outcome
SOURCE observational scale
Time frame: through study completion, an average of 1 year
The SOURCE observational scale is developed to primary answer the following question: Does the combination of the tool and the training improve observed (numerical) precision of information about treatment outcomes in clinical consultations? Min. value: 1 Max. value:4 Higher scores mean higher (numerical) precision
18 secondary outcomes
Continuing professional development (CPD) reaction Questionnaire
Time frame: through study completion, an average of 1 year
Patient Satisfaction Questionnaire (PSQ-5 patient and doctor version)
Time frame: 2 weeks
Shared Decision Making Questionnaire (SDMQ-9)
Time frame: 2 weeks
Decisional Conflict Scale (DCS)
Time frame: 2 weeks
EORTC QLQ - INFO25 + tailor made items on treatment outcome information
Time frame: 2 weeks
EORTC QLQ-C30
Time frame: 3 months vs. baseline
EORTC QLQ-OG25
Time frame: 3 months vs. baseline
Trust in the Oncologist Scale (TiOS-sf)
Time frame: 2 weeks
State-Trait Anxiety Inventory (STAI)
Time frame: 2 weeks vs. baseline
((Mini-)Mental Adjustment to Cancer scale ((Mini-)MAC)
Time frame: 2 weeks vs. baseline
Duration of consultation in minutes (min.)
Time frame: through study completion, an average of 1 year
Health care providers' personalization of treatment outcome information measured with SOURCE observational scale
Time frame: through study completion, an average of 1 year
Health care providers' tailoring of treatment outcome information measured with SOURCE observational scale
Time frame: through study completion, an average of 1 year
Health care providers' use of visualizations of treatment outcome information measured with SOURCE observational scale
Time frame: through study completion, an average of 1 year
Health care providers' use of time frames when giving treatment outcome information measured with SOURCE observational scale
Time frame: through study completion, an average of 1 year
Treatment outcome category of health care providers' treatment outcome information measured with SOURCE observational scale
Time frame: through study completion, an average of 1 year
Person initializing treatment outcome information measured with SOURCE observational scale
Time frame: through study completion, an average of 1 year
Health care providers' (numerical) precision of treatment outcome information measured with SOURCE observational scale simulated patient consultations (effect intervention)
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Oesophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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.
H WM van Laarhoven, Prof. Dr. principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tool and training in people with Oesophageal Cancer and Gastric Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 12 sites in Netherlands.
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 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Netherlands. 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 Loïs F. van de Water, MSc. (020-5665955, l.f.vandewater@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOURCE observational scale (time frame: through study completion, an average of 1 year). 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 16 Dec 2022.