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Pancreatic Ductal AdenocarcinomaNCT03693378

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

An observational study of Pancreatic Ductal Adenocarcinoma and Familial Pancreatic Cancer, run by Immunovia, Inc. at 21 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
How many people
1,349 participants
Where
21 sitesin 5 countries
Study dates
19 Jan 2016to 12 Nov 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

  • Ability to understand and the willingness to sign a written informed consent document
  • Individuals with the following family phenotype and age:
  • 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)
  • Two affected FDR with PDAC (≥50 years old OR 10 years before onset of an FDR)
  • 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)
  • Familial atypical multiple mole-melanoma (FAMMM) with confirmed pathogenic or likely pathogenic mutation variants in: p16, CDKN2A (≥50 years old)
Show all 9Show fewer
  • Known mutation carrier for STK11 (Peutz Jeghers Syndrome) (≥35 years old)
  • 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)
  • Hereditary pancreatitis with confirmed PRSS1 pathogenic or likely pathogenic history of pancreatitis (≥40 years old)

Who cannot join

  • None

Trial locations and contacts

21 sites in 5 countries.

21 sites in 5 countries

United States13 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • The Ohio State University

    Columbus, Ohio, 43210

  • Yale University

    New Haven, Connecticut, 06520-8327

  • New York University Hospital

    New York, New York, 10016

  • Columbia University

    New York, New York, 10027

  • Mount Sinai Hospital

    New York, New York, 10029-6574

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-6061

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213-2582

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University of Utah

    Salt Lake City, Utah, 84112

  • Stanford Gastroenterology and Hepatology

    Stanford, California, 94305

  • University of Massachusetts

    Worcester, Massachusetts, 01655

Other trials in United States

Sweden4 sites

  • Sahlgrenska University Hospital

    Gothenburg

  • Linköping University Hospital

    Linköping

  • Karolinska University Hospital

    Stockholm

  • Umeå University Hospital

    Umeå

Other trials in Sweden

Spain2 sites

  • University Hospital Ramon y Cajal

    Madrid

  • University Hospital Santiago De Compostela

    Santiago de Compostela

Other trials in Spain

Canada1 site

  • The Research Institute of the McGill University Health Centre

    Montreal

Other trials in Canada

United Kingdom1 site

  • University Collage London Hospital

    London

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Keywords
high-risk familial, screening program, pancreatic cancer
Medical subject headings
Pancreatic carcinoma, familial, Dysplastic Nevus Syndrome, Pancreatic Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validation of IMMray™ PanCan-d test

    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

    Measured: Approximately 18 months upon collection of approximately 2,000 subjects, or disease progression, whichever comes first

Secondary outcomes (1)

  1. Evaluation of the IMMray™ PanCan-d test performance

    Point Estimates and 95% confidence intervals

    Measured: Approximately 18 months upon collection of approximately 2,000 subjects, or disease progression, whichever comes first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2018
  2. Study start19 Jan 2016
  3. Primary completion12 Nov 2021
  4. Study completion12 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03693378
Sponsor's protocol ID
PanFAM-1
Status last verified
Aug 2020
First submitted
1 Oct 2018
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 30106639

  • 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.

    PubMed 35166713

  • 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.

    PubMed 34643612

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Ductal Adenocarcinoma and Familial Pancreatic Cancer, run by Immunovia, Inc. at 21 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Sweden, Spain, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validation of IMMray™ PanCan-d test (time frame: Approximately 18 months upon collection of approximately 2,000 subjects, or disease progression, whichever comes first). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03693378, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.

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