CompletedNot Applicable

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

United States1,349 participantsStarted 2016-01-19

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Ability to understand and the willingness to sign a written informed consent document
✓. 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)

What they're measuring

Validation of IMMray™ PanCan-d test

Timeframe: Approximately 18 months upon collection of approximately 2,000 subjects, or disease progression, whichever comes first

Trial details

NCT IDNCT03693378

SponsorImmunovia, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-11-12

View on ClinicalTrials.gov More Pancreatic Ductal Adenocarcinoma trials

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Ability to understand and the willingness to sign a written informed consent document
✓. 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)