Pancreatic Cancer Early Detection Program

NCT ID: NCT02206360

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2024-06-30

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.

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; Lynch Syndrome; Hereditary Pancreatitis; FAMMM; Familial Atypical Multiple Mole Melanoma; Peutz Jeghers Syndrome

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Endoscopic Ultrasound

Intervention Type: PROCEDURE

Magnetic Resonance Imaging (MRI)

Intervention Type: PROCEDURE

Interventions

Endoscopic Ultrasound

Intervention Type: PROCEDURE

Magnetic Resonance Imaging (MRI)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Known carrier of either the BRCA2 or CDKN2A mutation;

2. 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;

3. Individual with Peutz-Jeghers Syndrome;

4. 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;

5. Both parents affected, any age:

6. Any first degree relative diagnosed with pancreatic cancer under age 50;

7. Chronic Pancreatitis Syndrome, defined by either PRSS1 or SPINK1 mutations AND appropriate clinical and family history

Exclusion Criteria

1. Any medical condition that contraindicates endoscopy or biopsy

2. Any medical condition that contraindicates MRI

3. Status post partial or complete resection of the pancreas

4. History of pancreatic cancer, either endocrine or exocrine

5. 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).

6. diagnosis of dementia

7. Uncontrolled, current illness

8. Renal insufficiency with serum creatinine greater than 2.0 mg/dl

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

White Plains Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joshua Raff, MD

Director, Digestive Cancer Program, Center for Cancer Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

White Plains Hospital

White Plains, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37099777 (View on PubMed)

Other Identifiers

WPH 1401

Identifier Type: -

Identifier Source: org_study_id