A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

Recruiting at 15 trial locations

Overseen By David Kelson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Active malignancy, Cancer gene carrier, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

700 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to develop a minimally invasive test to diagnose pancreatic cancer at early stages of disease and monitor response to treatment.

Eligibility Criteria

Inclusion Criteria

Cohort 1: Advanced Pancreatic Cancer Cohort Inclusion Criteria

Histological or cytological confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma by the enrolling institution

Patient planning to receive systemic treatment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Blood specimens are drawn at study baseline for all cohorts

1 day

1 visit (in-person)

Treatment Monitoring

For patients with locally advanced or metastatic PDAC, blood is collected pre-treatment, after first chemotherapy cycle, every 8-12 weeks during treatment, and at disease progression

Ongoing during treatment

Multiple visits (in-person)

Follow-up

For patients with acute or chronic pancreatic conditions, blood specimens are drawn every 6-12 months

6-12 months

Periodic visits (in-person)

Treatment Details

Interventions

• Blood Draw
• Cyst Fluid
• Tumor Tissue Collection

Participant Groups

Group I: Locally Advanced or Metastatic Pancreatic Cancer Cohort Experimental Treatment 2 Interventions

For patients with locally advanced or metastatic PDAC, blood will be collected pre-treatment initiation (baseline), after first chemotherapy cycle, every 8-12 weeks while under treatment to coincide with restaging CT scan and at time of disease progression.

Group II: Healthy Control Experimental Treatment 1 Intervention

For normal controls, blood specimens will be drawn once at study baseline.

Group III: Chronic Benign Pancreatic Path,IPMC & Pancreatic Cyst Ctrl Experimental Treatment 3 Interventions

For patients with chronic pancreatitis, IPMN, or cysts, blood specimens will be drawn every 6-12 months.

Group IV: Acute Benign Pancreatic Pathology Control Cohort Experimental Treatment 2 Interventions

For patients with acute pancreatitis, blood specimens will be drawn at the time of acute pancreatitis and every 6-12 months thereafter

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Weizmann Institute of Science

Collaborator

Trials

60

Recruited

39,700+

Sheba Medical Center

Collaborator

Trials

741

Recruited

2,841,000+