Clinical trial · Observational
A Study of IMMray™ PanCan-d Test for Early Detection of Pancreatic Cancer in High-risk Groups
A Prospective, Multi-center Investigational Study of IMMray™ PanCan-d Diagnostic Assay for Early Detection of Pancreatic Ductal Adenocarcinoma in High-risk Populations
NCT03693378CI-TRIAL-00057425completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Familial Pancreatic Cancer | — | UNRESOLVED | — |
| FAMMM - Familial Atypical Mole Malignant Melanoma Syndrome | — | UNRESOLVED | — |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Validation of IMMray™ PanCan-d test
- timeFrame
- Approximately 18 months upon collection of approximately 2,000 subjects, or disease progression, whichever comes first
- description
- 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 outcomes (1)
- measure
- Evaluation of the IMMray™ PanCan-d test performance
- timeFrame
- Approximately 18 months upon collection of approximately 2,000 subjects, or disease progression, whichever comes first
- description
- Point Estimates and 95% confidence intervals
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDMellby 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 30106639
- DERIVEDBrand 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 35166713
- DERIVEDAbstracts 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 34643612