Try the modernized beta website. Learn more about the modernization effort.
Working… Menu
Trial record 1 of 1 for:    PANFAM
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03693378
Recruitment Status : Completed
First Posted : October 3, 2018
Last Update Posted : March 31, 2022
Information provided by (Responsible Party):
Immunovia, Inc.

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.

Condition or disease
Pancreatic Ductal Adenocarcinoma Familial Pancreatic Cancer FAMMM - Familial Atypical Mole Malignant Melanoma Syndrome

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 1349 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 19, 2016
Actual Primary Completion Date : November 12, 2021
Actual Study Completion Date : November 12, 2021

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
High-risk patient population, enrolled in established PDAC screening programs

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03693378

Show Show 21 study locations
Sponsors and Collaborators
Immunovia, Inc.
Layout table for investigator information
Study Director: Rolf Ehrnström Immunovia, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Immunovia, Inc. Identifier: NCT03693378    
Other Study ID Numbers: PanFAM-1
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Immunovia, Inc.:
high-risk familial
screening program
pancreatic cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Dysplastic Nevus Syndrome
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Glandular and Epithelial
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn