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

• ClinicalTrials.gov Identifier: NCT03693378
• Recruitment Status: Completed
• First Posted: October 3, 2018
• Last Update Posted: March 31, 2022
• Sponsor: Immunovia, Inc.
• Information provided by (Responsible Party): Immunovia, Inc.

Study Description

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 Design

• 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

Groups and Cohorts

Outcome Measures

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

Eligibility Criteria

• 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 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

Contacts and Locations

Locations

United States, California

Stanford Gastroenterology and Hepatology

Stanford, California, United States, 94305

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06520-8327

United States, Illinois

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

University of Massachusetts

Worcester, Massachusetts, United States, 01655

United States, New York

New York University Hospital

New York, New York, United States, 10016

Columbia University

New York, New York, United States, 10027

Mount Sinai Hospital

New York, New York, United States, 10029-6574

United States, Ohio

The Ohio State University

Columbus, Ohio, United States, 43210

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104-6061

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213-2582

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84112

Canada

The Research Institute of the McGill University Health Centre

Montréal, Canada

Spain

University Hospital Ramon y Cajal

Madrid, Spain

University Hospital Santiago De Compostela

Santiago De Compostela, Spain

Sweden

Sahlgrenska University Hospital

Gothenburg, Sweden

Linköping University Hospital

Linköping, Sweden

Karolinska University Hospital

Stockholm, Sweden

Umeå University Hospital

Umeå, Sweden

United Kingdom

University Collage London Hospital

London, United Kingdom

Sponsors and Collaborators

Immunovia, Inc.

Investigators

• Study Director: Rolf Ehrnström; Immunovia, Inc.

More Information

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Immunovia, Inc.
• ClinicalTrials.gov Identifier: NCT03693378
• Other Study ID Numbers: PanFAM-1
• First Posted: October 3, 2018
• Last Update Posted: March 31, 2022
• Last Verified: August 2020

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:

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