Pancreatic Cancer Early Detection Program (PCEDP)

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ClinicalTrials.gov Identifier: NCT02206360

Recruitment Status : Recruiting

First Posted : August 1, 2014

Last Update Posted : March 12, 2021

See Contacts and Locations

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Joshua Raff, MD, White Plains Hospital

Study Description

Brief 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 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.

Condition or disease	Intervention/treatment
Pancreatic Cancer Pancreas Cancer Pancreatic Adenocarcinoma Familial Pancreatic Cancer BRCA 1/2 HNPCC Lynch Syndrome Hereditary Pancreatitis FAMMM Familial Atypical Multiple Mole Melanoma Peutz Jeghers Syndrome	Procedure: Endoscopic Ultrasound Procedure: Magnetic Resonance Imaging (MRI)

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

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Study Type :	Observational [Patient Registry]
Estimated Enrollment :	100 participants
Observational Model:	Other
Time Perspective:	Prospective
Target Follow-Up Duration:	10 Years
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
Study Start Date :	April 2014
Estimated Primary Completion Date :	March 2024
Estimated Study Completion Date :	March 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Peutz-Jeghers syndrome Hereditary pancreatitis Melanoma

MedlinePlus related topics: Pancreatic Cancer

Genetic and Rare Diseases Information Center resources: Pancreatic Cancer Peutz-Jeghers Syndrome Hereditary Pancreatitis Familial Pancreatic Cancer Chronic Graft Versus Host Disease Neuroendocrine Tumor Neuroepithelioma

U.S. FDA Resources

Groups and Cohorts

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.	Procedure: Endoscopic Ultrasound Procedure: Magnetic Resonance Imaging (MRI)

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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.
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.
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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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.

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206360

Contacts

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Contact: Lisa Schuldt, BSN	914-849-7582	lschuldt@wphospital.org
Contact: Joshua P Raff, MD	914-849-7600	jraff@wphospital.org

Locations

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United States, New York
White Plains Hospital	Recruiting
White Plains, New York, United States, 10601
Contact: Lisa Schuldt, RN 914-849-7582 LSchuldt@wphospital.org
Principal Investigator: Joshua P Raff, MD

Sponsors and Collaborators

White Plains Hospital

More Information

Additional Information:

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Responsible Party:	Joshua Raff, MD, Director, Digestive Cancer Program, Center for Cancer Care, White Plains Hospital
ClinicalTrials.gov Identifier:	NCT02206360
Other Study ID Numbers:	WPH 1401
First Posted:	August 1, 2014 Key Record Dates
Last Update Posted:	March 12, 2021
Last Verified:	March 2021

Keywords provided by Joshua Raff, MD, White Plains Hospital:


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

Additional relevant MeSH terms:

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Melanoma Adenocarcinoma Pancreatic Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Peutz-Jeghers Syndrome Dysplastic Nevus Syndrome Pancreatitis Pancreatitis, Chronic Syndrome Disease Pathologic Processes Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type	Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Carcinoma Neoplasms, Glandular and Epithelial Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Neoplastic Syndromes, Hereditary

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