Pancreatic Cancer Biomarker Study

Active, not recruiting

• Conditions: Pancreatic Adenocarcinoma

• Registration Number: NCT04143152
• Lead Sponsor: Van Andel Research Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-29
• Study Start: 2021-01-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2024-08-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mercy Health Saint Mary's Hospital; 🇺🇸 Grand Rapids, Michigan, United States