Clinical trial NCT03693378: A Study of IMMray™ PanCan-d Test for Early Detection of Pancreatic Cancer in High-risk Groups
Official title: A Prospective, Multi-center Investigational Study of IMMray™ PanCan-d Diagnostic Assay for Early Detection of Pancreatic Ductal Adenocarcinoma in High-risk Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Ductal Adenocarcinoma
Familial Pancreatic Cancer
FAMMM - Familial Atypical Mole Malignant Melanoma Syndrome
Keywords: high-risk familial
screening program
pancreatic cancer
Lead sponsor: Immunovia, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-03
Enrollment: 1349
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: High-risk patient population, enrolled in established PDAC screening programs

Brief summary: PanFAM-1 is a clinical study for early detection of pancreatic cancer in high-risk groups. The goals of the study are to assess the performance and diagnostic accuracy of the IMMray™ PanCan-d test compared to standard-of-care imaging.

Detailed description: PanFAM-1 is a prospective, multi-center, investigational study, designed to assess the performance of the IMMray™ PanCan-d test in early detection of pancreatic ductal adenocarcinoma (PDAC) in high-risk populations. Specifically, the IMMray PanCan-d test uses state of the art machine learning algorithms to condense the multiple fluorescence data points generated by the test to a simple yes/no result. Thus, a highly complex statistical model uses the multi-dimensional nature of the test to generate a score, which is called a decision value. The score is compared to the established cut-off value for the test to inform the operator whether the patient sample is positive or negative for PDAC. This study will validate and evaluate the performance of the IMMray PanCan-d test in comparison to standard of care imaging approaches that are currently used in PDAC disease surveillance. Subjects in this study will be recruited from several European and North American research sites that have a PDAC surveillance program or established protocol for monitoring individuals considered to be at a high-risk for developing pancreatic cancer. Any subject that shows disease progression while on-study will be removed from the study to receive standard of care per institutional guidelines. Overall, this study poses minimal risk to subjects. The PanFAM-1 study is an adaptive study design over two approximately 18 month intervals, which are separated by an interim analysis to evaluate diagnostic accuracy of the IMMray PanCan-d test. This study is an observational period in which blood collections from eligible subjects will be evaluated using the IMMray PanCan-d test. Subjects will undergo scheduled imaging assessment and clinical evaluation consistent with the resarch sites' PDAC surveillance program. Subject data derived from the IMMray PanCan-d test during this portion of the study will be delayed from time of initial blood collection until the samples are analyzed. The analysis will compare IMMray PanCan-d test results for each subject to corresponding imaging assessments performed as part of standard of care PDAC surveillance. The study will only proceed to the interventional period if the interim analysis indicates that the diagnostic accuracy of the IMMray PanCan-d test is capable of detecting PDAC in high-risk subjects with the same or better ability as standard of care imaging. If at any time imaging assessments are considered positive for clinical disease then, regardless of IMMray PanCan-d test results, subjects will be managed according to institutional guidelines. All scheduled blood collections for purposes of this study will be halted and subjects will be removed from the study upon confirmation of PDAC.

Eligibility criteria: Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent document
2. Individuals with the following family phenotype and age:

   1. Two or more relatives with pancreatic adenocarcinomas (PDAC) on the same side of the family, where two PDAC-affected individuals are first degree related (FDR) + at least one PDAC-affected individual is a FDR of the Participant (≥50 years old OR 10 years before onset in family)
   2. Two affected FDR with PDAC (≥50 years old OR 10 years before onset of an FDR)
   3. Any of BRCA1, BRCA2, PALB2, ATM mutations confirmed pathogenic or likely pathogenic + one FDR or secondary degree related (SDR) with PDAC (≥50 years old OR 10 years before onset of an FDR and SDR)
   4. Familial atypical multiple mole-melanoma (FAMMM) with confirmed pathogenic or likely pathogenic mutation variants in: p16, CDKN2A (≥50 years old)
   5. Known mutation carrier for STK11 (Peutz Jeghers Syndrome) (≥35 years old)
   6. Lynch syndrome (HNPCC) with confirmed pathogenic or likely pathogenic variants in: MLH1, MSH2, MSH6, PMS2, or EPCAM + one FDR or SDR with PDAC (≥50 years old OR 10 years before onset of an FDR or SDR)
   7. Hereditary pancreatitis with confirmed PRSS1 pathogenic or likely pathogenic history of pancreatitis (≥40 years old)

Exclusion Criteria:

None

Primary outcomes:
measure: Validation of IMMray™ PanCan-d test
timeFrame: Approximately 18 months upon collection of approximately 2,000 subjects, or disease progression, whichever comes first
Secondary outcomes:
measure: Evaluation of the IMMray™ PanCan-d test performance
timeFrame: Approximately 18 months upon collection of approximately 2,000 subjects, or disease progression, whichever comes first
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Gastroenterology and Hepatology
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: New York
country: United States
facility: New York University Hospital
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Montréal
country: Canada
facility: The Research Institute of the McGill University Health Centre
city: Madrid
country: Spain
facility: University Hospital Ramon y Cajal
city: Santiago De Compostela
country: Spain
facility: University Hospital Santiago De Compostela
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Umeå
country: Sweden
facility: Umeå University Hospital
city: London
country: United Kingdom
facility: University Collage London Hospital
Study officials:
affiliation: Immunovia, Inc.
name: Rolf Ehrnström
role: STUDY_DIRECTOR
References:
citation: Mellby LD, Nyberg AP, Johansen JS, Wingren C, Nordestgaard BG, Bojesen SE, Mitchell BL, Sheppard BC, Sears RC, Borrebaeck CAK. Serum Biomarker Signature-Based Liquid Biopsy for Diagnosis of Early-Stage Pancreatic Cancer. J Clin Oncol. 2018 Oct 1;36(28):2887-2894. doi: 10.1200/JCO.2017.77.6658. Epub 2018 Aug 14.
citation: Brand RE, Persson J, Bratlie SO, Chung DC, Katona BW, Carrato A, Castillo M, Earl J, Kokkola A, Lucas AL, Moser AJ, DeCicco C, Mellby LD, King TC. Detection of Early-Stage Pancreatic Ductal Adenocarcinoma From Blood Samples: Results of a Multiplex Biomarker Signature Validation Study. Clin Transl Gastroenterol. 2022 Feb 14;13(3):e00468. doi: 10.14309/ctg.0000000000000468.
citation: Abstracts of Papers Submitted to the 52nd Meeting of the American Pancreatic Association, November 3-6, 2021, Miami Beach, Florida. Pancreas. 2021 Aug 1;50(7):1044-1115. doi: 10.1097/MPA.0000000000001904. No abstract available.