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

March 30, 2022 updated by: Immunovia, Inc.

A Prospective, Multi-center Investigational Study of IMMray™ PanCan-d Diagnostic Assay for Early Detection of Pancreatic Ductal Adenocarcinoma in High-risk Populations

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1349

Contacts and Locations

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

Study Locations

  • Canada
      • Montréal, Canada
        • The Research Institute of the McGill University Health Centre
  • Spain
      • Madrid, Spain
        • University Hospital Ramón y Cajal
      • Santiago De Compostela, Spain
        • University Hospital Santiago de Compostela
  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital
      • Linköping, Sweden
        • Linkoping University Hospital
      • Stockholm, Sweden
        • Karolinska University Hospital
      • Umeå, Sweden
        • Umea University Hospital
  • United Kingdom
      • London, United Kingdom
        • University Collage London Hospital
  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford Gastroenterology and Hepatology
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8327
        • Yale University
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts
    • New York
      • New York, New York, United States, 10016
        • New York University Hospital
      • New York, New York, United States, 10027
        • Columbia University
      • New York, New York, United States, 10029-6574
        • Mount Sinai Hospital
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-6061
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-2582
        • University of Pittsburgh Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

High-risk patient population, enrolled in established PDAC screening programs

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of IMMray™ PanCan-d test
Time Frame: Approximately 18 months upon collection of approximately 2,000 subjects, or disease progression, whichever comes first
Demonstrate 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 individuals
Approximately 18 months upon collection of approximately 2,000 subjects, or disease progression, whichever comes first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the IMMray™ PanCan-d test performance
Time Frame: Approximately 18 months upon collection of approximately 2,000 subjects, or disease progression, whichever comes first
Point Estimates and 95% confidence intervals
Approximately 18 months upon collection of approximately 2,000 subjects, or disease progression, whichever comes first

Collaborators and Investigators

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

Sponsor

Immunovia, Inc.

Investigators

  • Study Director: Rolf Ehrnström, Immunovia, Inc.

Publications and helpful links

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

General Publications

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 Major Dates

Study Start (Actual)

January 19, 2016

Primary Completion (Actual)

November 12, 2021

Study Completion (Actual)

November 12, 2021

Study Registration Dates

First Submitted

October 1, 2018

First Submitted That Met QC Criteria

October 1, 2018

First Posted (Actual)

October 3, 2018

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PanFAM-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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