Clinical trial NCT04143152: Pancreatic Cancer Biomarker Study
Official title: Evaluation of a Biomarker Panel for the Diagnosis and Prognosis of Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreatic Adenocarcinoma
Lead sponsor: Van Andel Research Institute
Sponsor class: OTHER
Collaborators: name: Spectrum Health Hospitals
name: Mercy Health
First posted: 2019-10-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from collaborating clinical sites by screening physician schedules and through physician referral.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnosis of adenocarcinoma of the pancreas
timeFrame: Up to three years
measure: Investigational biomarker panel for diagnosis
timeFrame: Enrollment
Secondary outcomes:
measure: Disease progression
timeFrame: Up to three years
measure: Investigational biomarker panel for disease surveillance
timeFrame: Up to three years
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Mercy Health Saint Mary's Hospital
state: Michigan
Study officials:
affiliation: Van Andel Research Institute
name: Brian Haab, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.