Clincosm LogoSign in Get a demo

Pancreatic Cancer Biomarker Study

Sponsor
Van Andel Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04143152
Collaborator
Spectrum Health Hospitals (Other), Mercy Health (Other)
300
Enrollment
1
Location
31
Anticipated Duration (Months)
9.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of a Biomarker Panel for the Diagnosis and Prognosis of Pancreatic Cancer
    Actual Study Start Date :
    Apr 1, 2021
    Anticipated Primary Completion Date :
    Oct 31, 2023
    Anticipated Study Completion Date :
    Oct 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Diagnosis of adenocarcinoma of the pancreas [Up to three years]

      Number of patients clinically diagnosed with pancreatic adenocarcinoma

    2. Investigational biomarker panel for diagnosis [Enrollment]

      sTRA biomarker and CA 19-9 levels at enrollment

    Secondary Outcome Measures

    1. Disease progression [Up to three years]

      Disease progression of pancreatic adenocarcinoma as measured by RESIST v1.1 criteria

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mercy Health Saint Mary's Hospital Grand Rapids Michigan United States 49503

    Sponsors and Collaborators

    • Van Andel Research Institute
    • Spectrum Health Hospitals
    • Mercy Health

    Investigators

    • Principal Investigator: Brian Haab, PhD, Van Andel Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Van Andel Research Institute
    ClinicalTrials.gov Identifier:
    NCT04143152
    Other Study ID Numbers:
    • 19021
    First Posted:
    Oct 29, 2019
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 4, 2022