Pancreatic Cancer Early Detection Program

Active, not recruiting

• Conditions: Pancreas Cancer; Peutz Jeghers Syndrome; FAMMM; Familial Pancreatic Cancer; HNPCC; Familial Atypical Multiple Mole Melanoma; Pancreatic Cancer; Pancreatic Adenocarcinoma; Hereditary Pancreatitis; BRCA 1/2
• Interventions: Procedure: Endoscopic Ultrasound; Procedure: Magnetic Resonance Imaging (MRI)

• Registration Number: NCT02206360
• Lead Sponsor: White Plains Hospital

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-08-01
• Primary Completion: 2024-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-24
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Any of the following:

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals at elevated risk for pancreatic cancer	Endoscopic Ultrasound	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.
Individuals at elevated risk for pancreatic cancer	Magnetic Resonance Imaging (MRI)	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.

Primary Outcome Measures

Name	Time	Method
Premalignant or malignant pancreatic conditions found with alternating EUS and MRI testing.	5 years	Number of Participants with Premalignant or Malignant Pancreatic Conditions, as a Measure of Safety and Efficacy

Secondary Outcome Measures

Name	Time	Method
Non-Pancreatic cancers diagnosed while on this protocol	5 years	Prospective collection and reporting of non-pancreatic cancers detected during this Protocol, including pancreatic cysts.
Clinical outcomes which occur as a result of this Protocol	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	5 years	Prospective collection and reporting of any complications that may be associated with early detection testing, including hospitalization, disability, and death.

Trial Locations

Locations (1)

White Plains Hospital; 🇺🇸 White Plains, New York, United States