A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

Recruiting

• Conditions: Pancreatic Neoplasms
• Interventions: Diagnostic Test: MRI/MRCP

• Registration Number: NCT03250078
• Lead Sponsor: Nuvance Health

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.

Detailed Description

Individuals 50 years of age and older who have a family history of pancreatic cancer will be recruited through the offices of primary care physicians and endocrinologists. Those meeting initial criteria will meet with a research APRN and will undergo a secondary screen to determine eligibility. Individuals enrolled in the study will undergo a five-minute psychological survey and donation of a blood sample for bio-bank analysis every 6 months for 3 years. MRI will be performed annually for 3 years (4 in total). Any abnormalities on MRI will be reviewed by a multi-disciplinary tumor board and discussed with the participant. The costs of MRI will be covered by the study.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-29
• Last Update Posted: 2024-04-01
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

1. Prior history of pancreatic cancer.
2. Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years.
3. Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the disease free interval is at least 5 years).
4. Hereditary pancreatitis.
5. eGFR < 30 mL/min
6. Contraindication to MRI examination or gadolinium contrast.
7. Pregnant or nursing women.
8. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FAMILIAL PANCREATIC CANCER and/or GENE MUTATION	MRI/MRCP	An inherited genetic syndrome associated with Pancreatic Cancer and/or with a strong family history of Pancreatic Cancer.

Primary Outcome Measures

Name	Time	Method
Early Stage Pancreatic Cancer or Precursor Lesions	Through study completion, up to 3 years	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.

Secondary Outcome Measures

Name	Time	Method
Serial Pancreatic MRI Screening	Through study completion, up to 3 years	Utility of MRI as a screening tool for Pancreatic Cancer in the study population.
Serum Bio-bank	Through study completion, up to 3 years	Banking serum from participants to isolate circulating exosomes and circulating tumor DNA.

Trial Locations

Locations (1)

Nuvance Health; 🇺🇸 Norwalk, Connecticut, United States