Pancreatic CancerPRO-TECTNCT04883450
PRedictiOn Algorithms for the DeTECTion of Early Stage Pancreatic Cancer
An observational study of Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma (PDAC), run by Kaiser Permanente at 1 site in United States.
Trial summary
Conduct a prospective study to assess the accuracy of a pancreatic cancer risk prediction model. Read more about this study
- Who is it for?
- Ages 50 to 84 years
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- Magnetic resonance imaging (MRI)
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 30 Jun 2025
- 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 50 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kaiser Permanente Southern California with at least 12 months prior to recruitment
Who may be able to join
- Patient must have 6 months of membership
- Patient has a measure for weight, Hemoglobin A1C, and Alanine transaminase (ALT) within the past 6 months
- Patient must have an increased predicted 18-month risk of pancreatic cancer based on the PRO-TECT model
- Speaks English or Spanish
Who cannot join
- Previous or current history of pancreatic cancer
- Metastatic cancer
- Current active cancer or undergoing chemotherapy for cancer
- Currently pregnant or breastfeeding
- Class IV heart failure
- Cirrhosis with ascites and/or varices
Show all 10Show fewer
- Currently in a skilled nursing facility or under hospice care
- Has metal parts or implanted devices in the body, such as a pacemaker, defibrillator, or shrapnel
- End stage renal disease
- Cognitive impairment such that the person is unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Southern California
Pasadena, California, 91101
About this study
Conduct a prospective study to assess the accuracy of a pancreatic cancer risk prediction model.
Read the detailed description
The goal of this study is to establish a platform for development and implementation of a data-driven risk model for detection of early stage pancreatic cancer within an integrated health care setting. Patients at increased risk for pancreatic cancer as identified by the risk model will be invited to participate in a prospective study to assess the accuracy of this approach for detection of early stage pancreatic cancer.
- Being tested
- Magnetic resonance imaging (MRI)
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)Diagnostic test
All enrolled participants will undergo magnetic resonance imaging (MRI) at their Baseline and 18-Month follow-up visit
| Study group | Role | What they receive |
|---|---|---|
| Risk of pancreatic cancer | Subjects with an increased predicted 18-month risk of pancreatic cancer Receives: Diagnostic Test: Magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pancreatic ductal adenocarcinoma (PDAC) in the high predicted risk group
Enrolled subjects will be followed for 18 months to determine the incidence rate of PDAC
Measured: 18-Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Feb 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bechien U Wu, MD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883450
- Sponsor's protocol ID
- 12135
- Other IDs
- R01CA230442
- Acronym
- PRO-TECT
- Status last verified
- Jan 2024
- First submitted
- 7 May 2021
- Last updated
- 16 Jan 2024
- 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 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRedictiOn Algorithms for the DeTECTion of Early Stage Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04883450
- Acronym / sponsor ID
- PRO-TECT / 12135
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 12 May 2021 (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.
Conduct a prospective study to assess the accuracy of a pancreatic cancer risk prediction model.
Detailed description
The goal of this study is to establish a platform for development and implementation of a data-driven risk model for detection of early stage pancreatic cancer within an integrated health care setting. Patients at increased risk for pancreatic cancer as identified by the risk model will be invited to participate in a prospective study to assess the accuracy of this approach for detection of early stage pancreatic cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risk of pancreatic cancer | – | Diagnostic Test: Magnetic resonance imaging (MRI)Subjects with an increased predicted 18-month risk of pancreatic cancer |
Who may qualify
- Ages
- 50 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kaiser Permanente Southern California with at least 12 months prior to recruitment
Key inclusion criteria (4 listed)
- Patient must have 6 months of membership
- Patient has a measure for weight, Hemoglobin A1C, and Alanine transaminase (ALT) within the past 6 months
- Patient must have an increased predicted 18-month risk of pancreatic cancer based on the PRO-TECT model
- Speaks English or Spanish
Key exclusion criteria (10 listed)
- Previous or current history of pancreatic cancer
- Metastatic cancer
- Current active cancer or undergoing chemotherapy for cancer
- Currently pregnant or breastfeeding
- Class IV heart failure
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 |
|---|---|---|
| Magnetic resonance imaging (MRI)All enrolled participants will undergo magnetic resonance imaging (MRI) at their Baseline and 18-Month follow-up visit | Diagnostic test | Risk of pancreatic cancer |
Primary outcome
Incidence of pancreatic ductal adenocarcinoma (PDAC) in the high predicted risk group
Time frame: 18-Month
Enrolled subjects will be followed for 18 months to determine the incidence rate of PDAC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- 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.
Bechien U Wu, MD, MPH principal investigator
Kaiser Permanente
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 Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma (PDAC), run by Kaiser Permanente 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 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 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?
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?
Incidence of pancreatic ductal adenocarcinoma (PDAC) in the high predicted risk group (time frame: 18-Month). 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 Jan 2024.