A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

NCT03250078 | Recruiting DMC

• 1 other identifier: 16-17
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this study is to screen and detect pancreatic cancer and precursor lesions in individuals with a strong family history or genetic predisposition to pancreatic cancer. Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for Pancreatic Cancer.

Conditions

Pancreatic Neoplasms

Keywords

Pancreas; Cancer; MRI; BRCA; Early Detection; Genetics; ATM; PALB2; Lynch; CDKN2A

Outcome Measures

Primary Outcomes (1)

• Early Stage Pancreatic Cancer or Precursor Lesions

  Incidence of Pancreatic Cancer or precursor lesions within a population of individuals with a strong family history of pancreatic cancer or known genetic mutation compared to the expected incidence in the general population.

  Through study completion, up to 3 years

Secondary Outcomes (2)

• Serial Pancreatic MRI Screening

  Through study completion, up to 3 years

• Serum Bio-bank

  Through study completion, up to 3 years

Study Arms (1)

FAMILIAL PANCREATIC CANCER and/or GENE MUTATION

An inherited genetic syndrome associated with Pancreatic Cancer and/or with a strong family history of Pancreatic Cancer.

Diagnostic Test: MRI/MRCP

Interventions

MRI/MRCP DIAGNOSTIC_TEST

An MRI/MRCP plus IV gadolinium contrast with high resolution imaging of the pancreas will be performed annually

FAMILIAL PANCREATIC CANCER and/or GENE MUTATION

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50-90 years of age. Strong family history of pancreatic cancer/ known genetic mutation

You may qualify if:

• For FPC: The individual has at least 2 first-degree relatives (FDR) with PC.
• For FPC: The individual has at least 3 first-, second-, or third-degree relatives with PC with at least 1 PC in a FDR.
• The individual is a known mutation carrier of BRCA1, BRCA2, MLH1, MSH2, MSH6, or PMS2, ATM, PALB2, CDKN2A, or similar high-risk gene mutation and has at least 1 first- or second-degree relative with PC.
• The individual is at least 50 years old or 10 years younger than the youngest relative with PC.
• ECOG Performance Status of 0-1.
• No known contraindications to MRI examination or gadolinium contrast.
• Willing to undergo MRI and screening for metal implants or metal injury.
• Estimated GFR \>29 mL/min
• Ability to provide informed consent.
• Willing to return to study site for all study assessments.

You may not qualify if:

• Prior history of pancreatic cancer.
• Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years.
• Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the disease free interval is at least 5 years).
• Hereditary pancreatitis.
• eGFR \< 30 mL/min
• Contraindication to MRI examination or gadolinium contrast.
• Pregnant or nursing women.
• Co-morbid illnesses or other concurrent disease which, in the judgment of the clinicians obtaining informed consent, would make the participant inappropriate for entry into this study.

Sponsors & Collaborators

• Nuvance Health: lead

Study Sites (1)

Nuvance Health

Norwalk, Connecticut, 06856, United States

RECRUITING

Related Publications (1)

• Kandiah J, Lo T, Jin D, Melchior L, Krebs TL, Anand N, Ingram S, Krumholtz P, Pandya D, Trinidad A, Dong XE, Seshadri R, Bauman J, Lee R, Frank RC. A Community-Based Pancreatic Cancer Screening Study in High-Risk Individuals: Preliminary Efficacy and Safety Results. Clin Transl Gastroenterol. 2022 Aug 1;13(8):e00516. doi: 10.14309/ctg.0000000000000516. Epub 2022 Jul 20.

  PMID: 35854467 DERIVED

Related Links

• An overview pancreatic cancer research at Nuvance Health

Biospecimen

Retention: SAMPLES WITH DNA

Serum sample

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Richard Frank, MD

  Nuvance Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tammy Lo, APRN

CONTACT

Tammy.Lo@nuvancehealth.org

Pramila Krumholtz, RN

CONTACT

Pramila.Krumholtz@nuvancehealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cancer Research

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: August 15, 2017
• Study Start: November 1, 2016
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed on an individual basis post submission. Requestors may be required to sign a data access agreement.

Locations

US (1)