NCT03693378

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,349

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
5 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2016

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2021

Completed
Last Updated

March 31, 2022

Status Verified

August 1, 2020

Enrollment Period

5.8 years

First QC Date

October 1, 2018

Last Update Submit

March 30, 2022

Conditions

Pancreatic Ductal AdenocarcinomaFamilial Pancreatic CancerFAMMM - Familial Atypical Mole Malignant Melanoma Syndrome

Keywords

high-risk familialscreening programpancreatic cancer

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (1)

  • Evaluation of the IMMray™ PanCan-d test performance

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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)
  • 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)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Stanford Gastroenterology and Hepatology

Stanford, California, 94305, United States

Location

Yale University

New Haven, Connecticut, 06520-8327, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

New York University Hospital

New York, New York, 10016, United States

Location

Columbia University

New York, New York, 10027, United States

Location

Mount Sinai Hospital

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

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6061, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

The Research Institute of the McGill University Health Centre

Montreal, Canada

Location

University Hospital Ramon y Cajal

Madrid, Spain

Location

University Hospital Santiago De Compostela

Santiago de Compostela, Spain

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Linköping University Hospital

Linköping, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Umeå University Hospital

Umeå, Sweden

Location

University Collage London Hospital

London, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 30106639BACKGROUND

  • 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.

    PMID: 35166713DERIVED

  • 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.

    PMID: 34643612DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Pancreatic carcinoma, familialDysplastic Nevus SyndromePancreatic Neoplasms

Condition Hierarchy (Ancestors)

NevusNevi and MelanomasNeoplasms by Histologic TypeNeoplasmsNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Rolf Ehrnström

    Immunovia, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 3, 2018

Study Start

January 19, 2016

Primary Completion

November 12, 2021

Study Completion

November 12, 2021

Last Updated

March 31, 2022

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(13)ES(2)SE(4)GB(1)CA(1)