Clinical trial NCT03250078: A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals
Official title: A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Neoplasms
Keywords: Pancreas
Cancer
MRI
BRCA
Early Detection
Genetics
ATM
PALB2
Lynch
CDKN2A
Lead sponsor: Nuvance Health
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50-90 years of age. Strong family history of pancreatic cancer/ known genetic mutation

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Early Stage Pancreatic Cancer or Precursor Lesions
timeFrame: Through study completion, up to 3 years
Secondary outcomes:
measure: Serial Pancreatic MRI Screening
timeFrame: Through study completion, up to 3 years
measure: Serum Bio-bank
timeFrame: Through study completion, up to 3 years
Other outcomes:
Locations:
city: Norwalk
country: United States
facility: Nuvance Health
state: Connecticut
Study officials:
affiliation: Nuvance Health
name: Richard Frank, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.