Pancreatic CancerPCEDPNCT02206360
Pancreatic Cancer Early Detection Program
An observational study of Pancreatic Cancer and Pancreas Cancer, run by White Plains Hospital at 1 site in United States.
Trial summary
Early detection testing is recommended for individuals at elevated risk for the development of Pancreatic Cancer. This Protocol will define sufficiently elevated risk as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreas Cancer, Pancreatic Adenocarcinoma
- What is being tested?
- Endoscopic Ultrasound and Magnetic Resonance Imaging (MRI)
- Type of treatment
- Surgery or procedure
- How many people
- 181 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Aug 2024
- How long will I take part?
- 10 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Individuals aged 18 and older, who carry sufficiently elevated risk for the development of pancreatic cancer, numerically defined as over (or near) 5 times the general population risk, as determined by their personal, familial, or genetic history.
Who may be able to join
- Known carrier of either the BRCA2 or CDKN2A mutation;
- Known carrier of any of the following mutations (BRCA1, MLH1, MSH2, PMS2, MSH6, EPCAM , P53, PALB2, APC, or ATM) PLUS first or second degree relative affected with pancreatic cancer;
- Individual with Peutz-Jeghers Syndrome;
- Familial Pancreatic Cancer, defined as at least two affected relatives with Pancreatic Cancer, who are first degree relatives with each other, and at least one of those affected must be first degree relative to the study subject;
- Both parents affected, any age:
- Any first degree relative diagnosed with pancreatic cancer under age 50;
- Chronic Pancreatitis Syndrome, defined by either PRSS1 or SPINK1 mutations AND appropriate clinical and family history
Who cannot join
- Any medical condition that contraindicates endoscopy or biopsy
- Any medical condition that contraindicates MRI
- Status post partial or complete resection of the pancreas
- History of pancreatic cancer, either endocrine or exocrine
- Clinical suspicion of pancreatic cancer, or any previous radiographic or histologic diagnosis of a pre-malignant finding, including IPMN (Intraductal papillary mucinous neoplasm) and PanIN (Pancreatic intraepithelial Neoplasm).
- diagnosis of dementia
- Uncontrolled, current illness
- Renal insufficiency with serum creatinine greater than 2.0 mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study to Analyze the Outcomes of Subjects Who - Based Upon Their Sufficiently Elevated Risk for the Development of Pancreatic Adenocarcinoma- Elect to Undergo Early Detection Testing
Early detection testing is recommended for individuals at elevated risk for the development of Pancreatic Cancer. This Protocol will define sufficiently elevated risk as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk. Our inclusion criteria has a strong focus on the risk for pancreatic cancer imparted by the presence of hereditary cancer genes, as well as by family history. Enrolled subjects will undergo Endoscopic Ultrasound (EUS) alternating with Magnetic Resonance Imaging (MRI), every six to 12 months, for up to 5 years.
Read the detailed description
Interested individuals can be referred by physicians, or by family or friends.
Individuals are informed that the purpose of this study is to collect outcome data following early detection testing based upon our criteria for elevated risk.
Consent is obtained by any of the co-investigators. Consent is obtained for the primary PCEDP, and also obtained to allow for data to be used by our Cancer Program.
We have a weekly review of all calls made and of all enrollments.
We have a monthly meeting to review all proceeding regarding the study.
Our IRB routinely reviews the proceedings of the study
Our institution has a monthly Clinical research Committee meeting.
- Conditions
- Pancreatic Cancer, Pancreas Cancer, Pancreatic Adenocarcinoma, Familial Pancreatic Cancer, BRCA 1/2, HNPCC
- Being tested
- Endoscopic Ultrasound, Magnetic Resonance Imaging (MRI)
- Keywords
- Pancreatic Cancer, Pancreatic Cancer Screening, Pancreas Cancer, Pancreatic Adenocarcinoma, Pancreatic Adenocarcinoma screening, Familial Pancreatic Cancer, BRCA 1/2, HNPCC, Lynch Syndrome, Hereditary Pancreatitis, FAMMM, Familial atypical multiple mole melanoma, Peutz Jeghers Syndrome, MRI, Magnetic Resonance Imaging, EUS, Endoscopic Ultrasound, Early detection, Screening
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic carcinoma, familial, Colorectal Neoplasms, Hereditary Nonpolyposis, Hereditary pancreatitis, Dysplastic Nevus Syndrome, Peutz-Jeghers Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic UltrasoundProcedure or surgery
Magnetic Resonance Imaging (MRI)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Individuals at elevated risk for pancreatic cancer | Individuals with an elevated risk of developing pancreatic cancer as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk. Receives: Procedure: Endoscopic Ultrasound; Procedure: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premalignant or malignant pancreatic conditions found with alternating EUS and MRI testing.
Number of Participants with Premalignant or Malignant Pancreatic Conditions, as a Measure of Safety and Efficacy
Measured: 5 years
Secondary outcomes (3)
Clinical outcomes which occur as a result of this Protocol
Prospective collection and reporting of any malignant conditions which occur as a result of this Protocol, including from surgery, or other testing.
Measured: 5 years
Complications of any interventions as a result of this Protocol
Prospective collection and reporting of any complications that may be associated with early detection testing, including hospitalization, disability, and death.
Measured: 5 years
Non-Pancreatic cancers diagnosed while on this protocol
Prospective collection and reporting of non-pancreatic cancers detected during this Protocol, including pancreatic cysts.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2024
- Study completionAug 2024
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 Pancreatic CancerStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 181 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- White Plains Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Raff, MD, White Plains Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206360
- Sponsor's protocol ID
- WPH 1401
- Acronym
- PCEDP
- Status last verified
- May 2024
- First submitted
- 29 Jul 2014
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Raff JP, Cook B, Jafri FN, Boxer N, Maldonado J, Hopkins U, Roayaie S, Noyer C. Successful Pancreatic Cancer Screening Among Individuals at Elevated Risk Using Endoscopic Ultrasound and Magnetic Resonance Imaging: A Community Hospital Experience. Pancreas. 2022 Nov-Dec 01;51(10):1345-1351. doi: 10.1097/MPA.0000000000002182.
PubMed 37099777
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Analyze the Outcomes of Subjects Who - Based Upon Their Sufficiently Elevated Risk for the Development of Pancreatic Adenocarcinoma- Elect to Undergo Early Detection Testing
- ClinicalTrials.gov ID
- NCT02206360
- Acronym / sponsor ID
- PCEDP / WPH 1401
- Conditions
- Pancreatic Cancer, Pancreas Cancer, Pancreatic Adenocarcinoma, Familial Pancreatic Cancer, BRCA 1/2, HNPCC
- Keywords
- Pancreatic Cancer, Pancreatic Cancer Screening, Pancreas Cancer, Pancreatic Adenocarcinoma, Pancreatic Adenocarcinoma screening, Familial Pancreatic Cancer, BRCA 1/2, HNPCC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- White Plains HospitalUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Mar 2024 (actual)
- Study completion
- Aug 2024 (actual)
- First posted
- 1 Aug 2014 (estimated)
- 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.
Early detection testing is recommended for individuals at elevated risk for the development of Pancreatic Cancer. This Protocol will define sufficiently elevated risk as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk. Our inclusion criteria has a strong focus on the risk for pancreatic cancer imparted by the presence of hereditary cancer genes, as well as by family history. Enrolled subjects will undergo Endoscopic Ultrasound (EUS) alternating with Magnetic Resonance Imaging (MRI), every six to 12 months, for up to 5 years.
Detailed description
Interested individuals can be referred by physicians, or by family or friends.
Individuals are informed that the purpose of this study is to collect outcome data following early detection testing based upon our criteria for elevated risk.
Consent is obtained by any of the co-investigators. Consent is obtained for the primary PCEDP, and also obtained to allow for data to be used by our Cancer Program.
We have a weekly review of all calls made and of all enrollments.
We have a monthly meeting to review all proceeding regarding the study.
Our IRB routinely reviews the proceedings of the study
Our institution has a monthly Clinical research Committee meeting.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals at elevated risk for pancreatic cancer | – | Procedure: Endoscopic Ultrasound, Procedure: Magnetic Resonance Imaging (MRI)Individuals with an elevated risk of developing pancreatic cancer as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals aged 18 and older, who carry sufficiently elevated risk for the development of pancreatic cancer, numerically defined as over (or near) 5 times the general population risk, as determined by their personal, familial, or genetic history.
Key inclusion criteria (7 listed)
- Known carrier of either the BRCA2 or CDKN2A mutation;
- Known carrier of any of the following mutations (BRCA1, MLH1, MSH2, PMS2, MSH6, EPCAM , P53, PALB2, APC, or ATM) PLUS first or second degree relative affected with pancreatic cancer;
- Individual with Peutz-Jeghers Syndrome;
- Familial Pancreatic Cancer, defined as at least two affected relatives with Pancreatic Cancer, who are first degree relatives with each other, and at least one of those affected must be first degree relative to the study subject;
- Both parents affected, any age:
Key exclusion criteria (8 listed)
- Any medical condition that contraindicates endoscopy or biopsy
- Any medical condition that contraindicates MRI
- Status post partial or complete resection of the pancreas
- History of pancreatic cancer, either endocrine or exocrine
- Clinical suspicion of pancreatic cancer, or any previous radiographic or histologic diagnosis of a pre-malignant finding, including IPMN (Intraductal papillary mucinous neoplasm) and PanIN (Pancreatic intraepithelial Neoplasm).
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 |
|---|---|---|
| Endoscopic Ultrasound | Procedure or surgery | Individuals at elevated risk for pancreatic cancer |
| Magnetic Resonance Imaging (MRI) | Procedure or surgery | Individuals at elevated risk for pancreatic cancer |
Primary outcome
Premalignant or malignant pancreatic conditions found with alternating EUS and MRI testing.
Time frame: 5 years
Number of Participants with Premalignant or Malignant Pancreatic Conditions, as a Measure of Safety and Efficacy
3 secondary outcomes
Clinical outcomes which occur as a result of this Protocol
Time frame: 5 years
Complications of any interventions as a result of this Protocol
Time frame: 5 years
Non-Pancreatic cancers diagnosed while on this protocol
Time frame: 5 years
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 25 Aug 2026.
- Derived from this study: PubMed 37099777Raff JP, Cook B, Jafri FN, Boxer N, Maldonado J, Hopkins U, Roayaie S, Noyer C. Successful Pancreatic Cancer Screening Among Individuals at Elevated Risk Using Endoscopic Ultrasound and Magnetic Resonance Imaging: A Community Hospital Experience. Pancreas. 2022 Nov-Dec 01;51(10):1345-1351. doi: 10.1097/MPA.0000000000002182.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pancreas Cancer, run by White Plains Hospital 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 7 inclusion and 8 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 25 Aug 2026. 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?
Premalignant or malignant pancreatic conditions found with alternating EUS and MRI testing. (time frame: 5 years). 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 NCT02206360, 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 25 Aug 2026.