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

Trial ID or NCT#

NCT03693378

Status

not recruiting iconNOT RECRUITING

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 Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. 1. Ability to understand and the willingness to sign a written informed consent document2. Individuals with the following family phenotype and age:
  2. 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:
  1. None
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Investigator(s)

Walter Park
Walter Park
Gastroenterologist, Pancreas specialist, Gastrointestinal specialist, Pancreatologist
Associate Professor of Medicine (Gastroenterology and Hepatology)

Contact us to find out if this trial is right for you.

Contact

Kellie Baumann
650) 725-3370

View on ClinicalTrials.gov