- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02206360
Pancreatic Cancer Early Detection Program (PCEDP)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Joshua P Raff, MD
- Phone Number: 914-849-7600
- Email: jraff@wphospital.org
Study Contact Backup
- Name: Jessica Maldonado, NP
- Phone Number: 914-849-2530
- Email: JMaldonado1@wphospital.org
Study Locations
-
-
New York
-
White Plains, New York, United States, 10601
- Recruiting
- White Plains Hospital
-
Principal Investigator:
- Joshua P Raff, MD
-
Contact:
- Jessica Maldonado, NP
- Phone Number: 914-849-2530
- Email: JMaldonado1@wphospital.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: Any of the following:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical outcomes which occur as a result of this Protocol
Time Frame: 5 years
|
Prospective collection and reporting of any malignant conditions which occur as a result of this Protocol, including from surgery, or other testing.
|
5 years
|
Complications of any interventions as a result of this Protocol
Time Frame: 5 years
|
Prospective collection and reporting of any complications that may be associated with early detection testing, including hospitalization, disability, and death.
|
5 years
|
Non-Pancreatic cancers diagnosed while on this protocol
Time Frame: 5 years
|
Prospective collection and reporting of non-pancreatic cancers detected during this Protocol, including pancreatic cysts.
|
5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- MRI
- Screening
- Pancreatic Cancer
- Magnetic Resonance Imaging
- HNPCC
- EUS
- Endoscopic Ultrasound
- Pancreas Cancer
- Early detection
- Pancreatic Adenocarcinoma
- BRCA 1/2
- Lynch Syndrome
- Hereditary Pancreatitis
- Familial Pancreatic Cancer
- Pancreatic Cancer Screening
- Pancreatic Adenocarcinoma screening
- FAMMM
- Familial atypical multiple mole melanoma
- Peutz Jeghers Syndrome
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Metabolic Diseases
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Disease Attributes
- Disease
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Endocrine Gland Neoplasms
- Genetic Diseases, Inborn
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Neoplastic Syndromes, Hereditary
- DNA Repair-Deficiency Disorders
- Pancreatic Diseases
- Neuroendocrine Tumors
- Nevi and Melanomas
- Intestinal Polyposis
- Hyperpigmentation
- Pigmentation Disorders
- Melanosis
- Lentigo
- Chronic Disease
- Nevus
- Syndrome
- Adenocarcinoma
- Colorectal Neoplasms, Hereditary Nonpolyposis
- Pancreatic Neoplasms
- Melanoma
- Pancreatitis
- Pancreatitis, Chronic
- Peutz-Jeghers Syndrome
- Dysplastic Nevus Syndrome
Other Study ID Numbers
- WPH 1401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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