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Completed

NCT Number: NCT02206360

Pancreatic Cancer Early Detection Program

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.

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Key information

Conditions

Pancreatic Cancer BRCA 1/2 Colonic Diseases Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Digestive System Diseases Digestive System Neoplasms Dysplastic Nevus Syndrome Endocrine Gland Neoplasms Endocrine System Diseases FAMMM Familial Atypical Multiple Mole Melanoma Familial Pancreatic Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn HNPCC Hereditary Pancreatitis Hyperpigmentation Intestinal Diseases Intestinal Neoplasms Intestinal Polyposis Lentigo Lynch Syndrome Melanosis Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplastic Syndromes, Hereditary Nevi and Melanomas Nevus Nutritional and Metabolic Diseases Pancreas Cancer Pancreatic Adenocarcinoma Pancreatic Diseases Pancreatic Neoplasms Pancreatic carcinoma, familial Peutz Jeghers Syndrome Peutz-Jeghers Syndrome Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

White Plains Hospital

White Plains, New York, 10601, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Ultrasound

Procedure

Magnetic Resonance Imaging (MRI)

Procedure

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

White Plains Hospital

Other

Registry information

Official study 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

Acronym: PCEDP

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2014
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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