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 :
Completed
First Posted : October 3, 2018
Last Update Posted : March 31, 2022
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Condition or disease |
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Pancreatic Ductal Adenocarcinoma Familial Pancreatic Cancer FAMMM - Familial Atypical Mole Malignant Melanoma Syndrome |
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 |

- 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
- 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

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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 |
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 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)
Exclusion Criteria:
None

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

Study Director: | Rolf Ehrnström | Immunovia, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Immunovia, Inc. |
ClinicalTrials.gov Identifier: | NCT03693378 |
Other Study ID Numbers: |
PanFAM-1 |
First Posted: | October 3, 2018 Key Record Dates |
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 |
high-risk familial screening program pancreatic cancer |
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 |