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

Not Recruiting

Trial ID: NCT03693378

Purpose

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.

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

Eligibility


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

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kellie Baumann
650) 725-3370

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