Pancreatic Cancer Biomarker Study

Pancreatic Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04143152
• Other study ID #: 19021
• Status: Active, not recruiting
• Start date: January 1, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Van Andel Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: October 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Adenocarcinoma

Locations

Country	Name	City	State
United States	Mercy Health Saint Mary's Hospital	Grand Rapids	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Van Andel Research Institute	Mercy Health, Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of adenocarcinoma of the pancreas	Number of patients clinically diagnosed with pancreatic adenocarcinoma	Up to three years
Primary	Investigational biomarker panel for diagnosis	sTRA biomarker and CA 19-9 levels at enrollment	Enrollment
Secondary	Disease progression	Disease progression of pancreatic adenocarcinoma as measured by RESIST v1.1 criteria	Up to three years
Secondary	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