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2021-01-01
2024-08-31
2024-10-31
300
NCT04143152
Van Andel Research Institute
Van Andel Research Institute
OBSERVATIONAL
Pancreatic Cancer Biomarker Study
This is a non-treatment, blood collection study to evaluate biomarker panels for the diagnosis and prognosis of pancreatic cancer.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-10-16 | N/A | 2024-04-22 |
2019-10-28 | N/A | 2024-04-23 |
2019-10-29 | N/A | 2024-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/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 |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Disease progression | Disease progression of pancreatic adenocarcinoma as measured by RESIST v1.1 criteria | Up to three years |
| 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
