Trial record 1 of 1 for:
PANFAM
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 |
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Recruitment Status :
Recruiting
First Posted : October 3, 2018
Last Update Posted : January 21, 2019
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Sponsor:
Immunovia, Inc.
Information provided by (Responsible Party):
Immunovia, Inc.
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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 |
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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Melanoma
MedlinePlus related topics:
Pancreatic Cancer
Primary Outcome Measures :
- 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 :
- 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:
- Ability to understand and the willingness to sign a written informed consent document
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Individuals with the following family phenotype and age:
- 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)
- Two affected FDR with PDAC (≥50 years old OR 10 years before onset)
- 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)
- 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)
- 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 + 1 FDR or SDR with PDAC (≥50 years old OR 10 years before onset)
- 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.:
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high-risk familial screening program pancreatic cancer |
Additional relevant MeSH terms:
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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 |