Pancreatic Cancer Biomarker Study

NCT04143152 | Active Not Recruiting

• 1 other identifier: 19021
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Disease progression

  Up to three years

• Investigational biomarker panel for disease surveillance

  Up to three years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Van Andel Research Institute: lead
• Corewell Health West: collaborator
• Mercy Health: collaborator

Study Sites (1)

Mercy Health Saint Mary's Hospital

Grand Rapids, Michigan, 49503, United States

Location

Related 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.

  PMID: 30617132 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood specimens

Study Officials

• Brian Haab, PhD

  Van Andel Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 29, 2019
• Study Start: January 1, 2021
• Primary Completion: August 31, 2024
• Study Completion: October 31, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)