A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

Pancreatic Neoplasms Clinical Trial

Official title:

A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03250078
• Other study ID #: 16-17
• Status: Recruiting
• Start date: November 2016
• Est. completion date: November 2026

Study information

• Verified date: March 2024
• Source: Nuvance Health
• Contact: Tammy Lo, APRN
• Email: Tammy.Lo[@]nuvancehealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Registration-Inclusion Criteria for FAMILIAL PANCREATIC CANCER (FPC) and those with a BRCA1, BRCA2, LYNCH SYNDROME, ATM, PALB2, CDKN2A, or related gene mutation (one of the following is required for questions 1-3)

1. For FPC: The individual has at least 2 first-degree relatives (FDR) with PC.

2. For FPC: The individual has at least 3 first-, second-, or third-degree relatives with PC with at least 1 PC in a FDR.

3. 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.

4. The individual is at least 50 years old or 10 years younger than the youngest relative with PC.

5. ECOG Performance Status of 0-1.

6. No known contraindications to MRI examination or gadolinium contrast.

7. Willing to undergo MRI and screening for metal implants or metal injury.

8. Estimated GFR >29 mL/min

9. Ability to provide informed consent.

10. Willing to return to study site for all study assessments.

Registration-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.

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Nuvance Health	Norwalk	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Nuvance Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serial Pancreatic MRI Screening	Utility of MRI as a screening tool for Pancreatic Cancer in the study population.	Through study completion, up to 3 years
Secondary	Serum Bio-bank	Banking serum from participants to isolate circulating exosomes and circulating tumor DNA.	Through study completion, up to 3 years

External Links

•   An overview pancreatic cancer research at Nuvance Health