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Clinical Trial Record

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A Study of IMMray™ PanCan-d Test for Early Detection of Pancreatic Cancer in High-risk Groups

2016-01-19

2021-11-12

2021-11-12

1349

Study Overview

A Study of IMMray™ PanCan-d Test for Early Detection of Pancreatic Cancer in High-risk Groups

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.

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.

  • Pancreatic Ductal Adenocarcinoma
  • Familial Pancreatic Cancer
  • FAMMM - Familial Atypical Mole Malignant Melanoma Syndrome
    • PanFAM-1

    Study Record Dates

    These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

    Study Registration Dates Results Reporting Dates Study Record Updates

    2018-10-01  

    N/A  

    2022-03-30  

    2018-10-01  

    N/A  

    2022-03-31  

    2018-10-03  

    N/A  

    2020-08  

    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    Design Details

    Primary Purpose:
    N/A

    Allocation:
    N/A

    Interventional Model:
    N/A

    Masking:
    N/A

    Arms and Interventions

    Participant Group/ArmIntervention/Treatment
    Primary Outcome MeasuresMeasure DescriptionTime Frame
    Validation of IMMray™ PanCan-d testDemonstrate that the IMMray PanCan-d test is equal or better than the reference standard imaging procedures for early detection of PDAC in asymptomatic high risk individualsApproximately 18 months upon collection of approximately 2,000 subjects, or disease progression, whichever comes first
    Secondary Outcome MeasuresMeasure DescriptionTime Frame
    Evaluation of the IMMray™ PanCan-d test performancePoint Estimates and 95% confidence intervalsApproximately 18 months upon collection of approximately 2,000 subjects, or disease progression, whichever comes first

    Contacts and Locations

    This section provides the contact details for those conducting the study, and information on where this study is being conducted.

    Participation Criteria

    Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

    Ages Eligible for Study:
    ALL

    Sexes Eligible for Study:

    Accepts Healthy Volunteers:
    1

      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

    Collaborators and Investigators

    This is where you will find people and organizations involved with this study.

      • STUDY_DIRECTOR: Rolf Ehrnström, Immunovia, Inc.

      Publications

      The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

      General Publications

      • 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.
      • 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.
      • 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.
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