Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
300 participants
OBSERVATIONAL
2021-01-01
2024-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Diagnostic/prognostic cohort
Patients being evaluated for a potential pancreatic abnormality or for potential treatment for pancreatic adenocarcinoma.
No interventions assigned to this group
Surveillance Cohort
Patients who are being monitored for recurrence following surgical or medical treatment for pancreatic adenocarcinoma
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Spectrum Health Hospitals
OTHER
Mercy Health
OTHER
Van Andel Research Institute
OTHER
Responsible Party
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Principal Investigators
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Brian Haab, PhD
Role: PRINCIPAL_INVESTIGATOR
Van Andel Research Institute
Locations
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Mercy Health Saint Mary's Hospital
Grand Rapids, Michigan, United States
Countries
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References
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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.
Other Identifiers
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19021
Identifier Type: -
Identifier Source: org_study_id
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