Pancreatic Cancer Biomarker Study

Evaluation of a Biomarker Panel for the Diagnosis and Prognosis of Pancreatic Cancer

This is a non-treatment, blood collection study to evaluate biomarker panels for the diagnosis and prognosis of pancreatic cancer.

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Adenocarcinoma

Detailed Description

This is a non-treatment, blood collection study to evaluate biomarker panels for the diagnosis and prognosis of pancreatic cancer.

Study participants will be recruited by physician referral or from a list of clinical patients being evaluated for a potential pancreatic abnormality or for potential treatment of pancreatic cancer. Additionally, a surveillance cohort will be recruited among individuals who are being monitored for recurrence following surgical or medical treatment for pancreatic cancer.

Peripheral blood specimens will be collected from all participants at time of enrollment. Additional specimens may be collected from surveillance cohort participants no more frequently than once every 3 months as clinically indicated.

The specimens will be sent to a clinical lab for sTRA biomarker and CA19-9 analysis. Participants will be followed for 36 months to track clinical outcomes. The performance of the investigation biomarker for the diagnosis, prognosis, or surveillance of pancreatic cancer will be compared to the performance of CA19-9.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Mercy Health Saint Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants will be recruited from collaborating clinical sites by screening physician schedules and through physician referral.

Description

Inclusion Criteria:

Diagnosis/Prognosis Cohort

• Patients being evaluated for possible pancreatic abnormality, via additional radiological test (endoscopic ultrasound, abdominal CT scan), blood test (CA19-9), or other diagnostic procedure.
• Patients being evaluated for medical or surgical treatment for pancreatic cancer or pancreatitis on the basis of previous clinical and radiological findings.

Surveillance Cohort

• Patients being monitored or who will be monitored for potential recurrence of pancreatic cancer following surgical or medical treatment of pancreatic adenocarcinoma.

Exclusion Criteria:

• The participant is unwilling or unable to provide written informed consent.
• In the investigator's opinion, the participant is unsuitable for the study.
• The participant does not speak English.
• The participant is a prisoner.
• The participant is known to be pregnant.
• The participant is less than 18 years of age.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Diagnostic/prognostic cohort; Patients being evaluated for a potential pancreatic abnormality or for potential treatment for pancreatic adenocarcinoma.
Surveillance Cohort; Patients who are being monitored for recurrence following surgical or medical treatment for pancreatic adenocarcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of adenocarcinoma of the pancreas	Number of patients clinically diagnosed with pancreatic adenocarcinoma	Up to three years
Investigational biomarker panel for diagnosis	sTRA biomarker and CA 19-9 levels at enrollment	Enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease progression	Disease progression of pancreatic adenocarcinoma as measured by RESIST v1.1 criteria	Up to three years
Investigational biomarker panel for disease surveillance	sTRA biomarker and CA 19-9 levels measured at any time point deemed clinically relevant for standard of care.	Up to three years

Collaborators and Investigators

• Sponsor: Van Andel Research Institute
• Collaborators: Spectrum Health Hospitals; Mercy Health
• Investigators: Principal Investigator: Brian Haab, PhD, Van Andel Research Institute

Publications and helpful links

General Publications

• Staal B, Liu Y, Barnett D, Hsueh P, He Z, Gao C, Partyka K, Hurd MW, Singhi AD, Drake RR, Huang Y, Maitra A, Brand RE, Haab BB. The sTRA Plasma Biomarker: Blinded Validation of Improved Accuracy Over CA19-9 in Pancreatic Cancer Diagnosis. Clin Cancer Res. 2019 May 1;25(9):2745-2754. doi: 10.1158/1078-0432.CCR-18-3310. Epub 2019 Jan 7.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 19021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No