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

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ClinicalTrials.gov Identifier: NCT03693378
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : January 21, 2019
Sponsor:
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.

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multi-center Investigational Study of IMMray™ PanCan-d Diagnostic Platform for Early Detection of Pancreatic Ductal Adenocarcinoma in High-risk Populations
Actual Study Start Date : January 19, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020





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
Serum


Information from the National Library of Medicine

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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
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 2 PDAC-affected individuals are first degree related (FDR) to each other + at least 1 PDAC-affected individual is a FDR of the Participant (≥50 years old OR 10 years before onset)
    2. Two affected FDR with PDAC (≥50 years old OR 10 years before onset)
    3. Any of BRCA1, BRCA2, PALB2, ATM mutations confirmed pathogenic or likely pathogenic + 1 FDR or secondary degree related (SDR) with PDAC (≥50 years old OR 10 years before onset)
    4. Familial atypical multiple mole-melanoma (FAMMM) with confirmed pathogenic or likely pathogenic mutation variants in: p16, CDKN2A (≥50 years old OR 10 years before onset)
    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 + 1 FDR or SDR with PDAC (≥50 years old OR 10 years before onset)
    7. Hereditary pancreatitis with confirmed PRSS1 pathogenic or likely pathogenic history of pancreatitis (≥40 years old OR 10 years before onset)

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 ClinicalTrials.gov identifier (NCT number): NCT03693378


Contacts
Contact: Cindy Callahan, RN cindy.callahan@immunovia.com
Contact: Susanne Glantz susanne.glantz@immunovia.com

Locations
United States, Connecticut
Yale University Not yet recruiting
New Haven, Connecticut, United States, 06520-8327
Contact: James Farrell       james.j.farrell@yale.edu   
Principal Investigator: James Farrell         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Daniel Chung       Chung.Daniel@mgh.harvard.edu   
Principal Investigator: Daniel Chung         
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Giles Whalen       Giles.Whalen@umassmemorial.org   
Principal Investigator: Giles Whalen         
United States, New York
New York University Hospital Not yet recruiting
New York, New York, United States, 10016
Contact: Diane Simeone       Diane.Simeone@nyulangone.org   
Principal Investigator: Diane Simeone         
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029-6574
Contact       aimee.lucas@mssm.edu   
Principal Investigator: Aimee Lucas         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Brett Sheppard       sheppard@ohsu.edu   
Principal Investigator: Brett Sheppard         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-6061
Contact: Bryson Katona       Bryson.Katona@uphs.upenn.edu   
Principal Investigator: Bryson Katona         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213-2582
Contact: Randall Brand       brandre@upmc.edu   
Principal Investigator: Randall Brand         
Canada
The Research Institute of the McGill University Health Centre Recruiting
Montréal, Canada
Contact: George Zogopoulos       George.zogopoulos@mcgill.ca   
Principal Investigator: George Zogopoulos         
Spain
University Hospital Ramon y Cajal Recruiting
Madrid, Spain
Contact: Alfredo Carrato       acarrato@telefonica.net   
Principal Investigator: Alfredo Carrato         
University Clinic Navarra Not yet recruiting
Pamplona, Spain
Contact: Teresa Herraiz       mherraizb@unav.es   
Principal Investigator: Teresa Herraiz         
University Hospital Santiago De Compostela Not yet recruiting
Santiago De Compostela, Spain
Contact: Juan Enrique Dominguez-Munoz       edominguezmunoz@gmail.com   
Principal Investigator: Juan Enrique Dominguez-Munoz         
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Jan Persson       Jan.Persson@vgregion.se   
Principal Investigator: Jan Persson         
Linköping University Hospital Recruiting
Linköping, Sweden
Contact: Thomas Gasslander       thomas.gasslander@liu.se   
Principal Investigator: Thomas Gasslander         
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Urban Arnelo       Urban.arnelo@ki.se   
Principal Investigator: Urban Arnelo         
Umeå University Hospital Recruiting
Umeå, Sweden
Contact: Malin Sund, Prof       malin.sund@umu.se   
Principal Investigator: Malin Sund, Prof         
Sponsors and Collaborators
Immunovia, Inc.
Investigators
Study Director: Rolf Ehrnström Immunovia, Inc.

Publications:
Responsible Party: Immunovia, Inc.
ClinicalTrials.gov Identifier: NCT03693378     History of Changes
Other Study ID Numbers: PanFAM-1
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Adenocarcinoma
Pancreatic Neoplasms
Melanoma
Carcinoma
Dysplastic Nevus Syndrome
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nevus
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn