Pancreatic Cancer Biomarker Study

Van Andel Research Institute

Status: Active, not recruiting

Conditions: Pancreatic Adenocarcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT04143152

19021

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

Diagnostic/prognostic cohort

Description:

Patients being evaluated for a potential pancreatic abnormality or for potential treatment for pancreatic adenocarcinoma.

Surveillance Cohort

Description:

Patients who are being monitored for recurrence following surgical or medical treatment for pancreatic adenocarcinoma