Pancreatic Cancer Early Detection Program

NCT02206360 | Active Not Recruiting DMC

• 1 other identifier: WPH 1401
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• 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

  5 years

Secondary Outcomes (3)

• Clinical outcomes which occur as a result of this Protocol

  5 years

• Complications of any interventions as a result of this Protocol

  5 years

• Non-Pancreatic cancers diagnosed while on this protocol

  5 years

Study Arms (1)

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)

Interventions

Endoscopic Ultrasound PROCEDURE

Individuals at elevated risk for pancreatic cancer

Magnetic Resonance Imaging (MRI) PROCEDURE

Individuals at elevated risk for pancreatic cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• White Plains Hospital: lead

Study Sites (1)

White Plains Hospital

White Plains, New York, 10601, United States

Location

Related Publications (1)

• 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.

  PMID: 37099777 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic carcinoma, familial; Colorectal Neoplasms, Hereditary Nonpolyposis; Hereditary pancreatitis; Dysplastic Nevus Syndrome; Peutz-Jeghers Syndrome

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Neoplastic Syndromes, Hereditary; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Nevus; Nevi and Melanomas; Neoplasms by Histologic Type; Intestinal Polyposis; Lentigo; Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Digestive Cancer Program, Center for Cancer Care

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: August 1, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

US (1)