Surgery Risk AssessmentNCT06311032
Clinician Decision Making Regarding Surveillance for Low-risk Intraductal Papillary Mucinous Neoplasms of The Pancreas
An observational study of Surgery Risk Assessment, run by NYU Langone Health at 1 site in United States.
Trial summary
The main objective of this study is to determine how physicians make decisions regarding surveillance of Intraductal Papillary Mucinous Neoplasm's (IPMN) of the pancreas. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery Risk Assessment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2023to 28 Jul 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The Pancreatic Cancer Early Detection (PRECEDE) Consortium is an international, multi-institutional collaborative group of experts to increase survival for pancreatic cancer patients by improving early detection, screening, risk modeling and prevention for those with a heritable risk for pancreatic cancer, through a novel model of collaboration and data sharing. The PACYFIC group is comprised of Dutch surgeons, gastroenterologists, oncologists, radiologists, radiotherapists, and pathologists. Their common interest is to improve the prognosis of patients with pancreatic cancer, by initiating and performing research, and organizing ongoing training.
Who may be able to join
- Membership in either the PACYFIC or PRECEDE consortiums
- Physician with expertise in the management of IPMN
- Able and willing to complete survey
Who cannot join
- Not a member of either the PACYFIC or PRECEDE consortiums
- Not a physician with expertise in the management of IPMN
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to determine how physicians make decisions regarding surveillance of Intraductal Papillary Mucinous Neoplasm's (IPMN) of the pancreas.
Read the detailed description
The study will employ a survey design that poses physicians with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case.
This will be a double-blinded randomized survey study, featuring two arms. Providers will be randomized to either be provided with, or not provided with a risk stratification tool (DART-1) when presented with their clinical case vignettes.
- Conditions
- Surgery Risk Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vignettes with Risk Stratification Tool | Physicians will be posed with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case. Participants in this arm will be provided a risk stratification tool (DART-1) when presented with their clinical case vignettes. The DART-1 is a 5-question tool which calculates the probability (%) of IPMNs without worrisome features or high-risk stigmata at diagnosis. | |
| Vignettes without Risk Stratification Tool | Physicians will be posed with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case. Participants in this arm will be not be provided a risk stratification tool when presented with their clinical case vignettes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Decisions to Stop Surveillance Imaging
Measured: Day 1
Number of Decisions to Continue Surveillance Imaging
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start29 Mar 2023
- Primary completion28 Jun 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery Risk AssessmentStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Greg Sacks, MD, MPH, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311032
- Sponsor's protocol ID
- 22-01227
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Greg.Sacks@nyulangone.org. The statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinician Decision Making Regarding Surveillance for Low-risk Intraductal Papillary Mucinous Neoplasms of The Pancreas
- ClinicalTrials.gov ID
- NCT06311032
- Acronym / sponsor ID
- 22-01227
- Conditions
- Surgery Risk Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 15 Mar 2024 (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 main objective of this study is to determine how physicians make decisions regarding surveillance of Intraductal Papillary Mucinous Neoplasm's (IPMN) of the pancreas.
Detailed description
The study will employ a survey design that poses physicians with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case.
This will be a double-blinded randomized survey study, featuring two arms. Providers will be randomized to either be provided with, or not provided with a risk stratification tool (DART-1) when presented with their clinical case vignettes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vignettes with Risk Stratification Tool | – | –Physicians will be posed with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case. Participants in this arm will be provided a risk stratification tool (DART-1) when presented with their clinical case vignettes. The DART-1 is a 5-question tool which calculates the probability (%) of IPMNs without worrisome features or high-risk stigmata at diagnosis. |
| Vignettes without Risk Stratification Tool | – | –Physicians will be posed with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case. Participants in this arm will be not be provided a risk stratification tool when presented with their clinical case vignettes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The Pancreatic Cancer Early Detection (PRECEDE) Consortium is an international, multi-institutional collaborative group of experts to increase survival for pancreatic cancer patients by improving early detection, screening, risk modeling and prevention for those with a heritable risk for pancreatic cancer, through a novel model of collaboration and data sharing. The PACYFIC group is comprised of Dutch surgeons, gastroenterologists, oncologists, radiologists, radiotherapists, and pathologists. Their common interest is to improve the prognosis of patients with pancreatic cancer, by initiating and performing research, and organizing ongoing training.
Key inclusion criteria (3 listed)
- Membership in either the PACYFIC or PRECEDE consortiums
- Physician with expertise in the management of IPMN
- Able and willing to complete survey
Key exclusion criteria (2 listed)
- Not a member of either the PACYFIC or PRECEDE consortiums
- Not a physician with expertise in the management of IPMN
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
Number of Decisions to Stop Surveillance Imaging
Time frame: Day 1
Number of Decisions to Continue Surveillance Imaging
Time frame: Day 1
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 15 Mar 2024.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Greg.Sacks@nyulangone.org. The statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Greg Sacks, MD, MPH, PhD principal investigator
NYU Langone Health
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 Surgery Risk Assessment, run by NYU Langone Health at 1 site 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 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. 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 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?
Number of Decisions to Stop Surveillance Imaging (time frame: Day 1). The study lists 2 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 15 Mar 2024.