Optical and Biochemical Biomarkers in Early Pancreatic Cancer

NCT ID: NCT03404661

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 346 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-11
• Study Completion Date: 2022-03-10

Brief Summary

The purpose of this study is to develop a test for detection of pancreatic cancer by looking at the subject's DNA.

Detailed Description

Pancreatic juice collection is performed by intravenous injection of FDA approved synthetic human secretin (ChiRhoClin Inc., Burtonsville, MD) at a dose of 0.2 µg/kg will be administered while the endoscope is positioned in the second portion of the duodenum. From within the duodenum and without cannulation of the papilla of Vater, a 2.3-mm plastic aspiration catheter (Olympus, Tokyo, Japan) will be passed through the biopsy channel of the endoscope until visible on screen in the endoscopic monitor. Once active visible secretion via the papilla has begun, the first 10 ml of pancreatic juice will be collected via suctioning. This entire process from secretin injection to sample collection takes an average of 5 minutes. The sample is then aliquoted into 2 ml ampules, which are snap-frozen in liquid nitrogen (or portable rapid-freeze freezer) and freezer-stored until the assays are performed. The top 10 candidate markers from discovery and validation on tissue (AUCs >0.95) and from pilot pancreatic-juice testing (AUCs >0.9) will be evaluated in this study. Following extraction from an equivalent of 0.4 ml pancreatic juice, DNA will be bisulfite treated using optimized methods. Then, an assay of aberrant methylation on target genes will be conducted using the QuARTS technique. Results will be normalized to either a human DNA marker (eg, beta-actin) or a methylated DNA marker identified for normal pancreatic epithelium.

Conditions

Pancreatic Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Pancreas Cancer Subjects

Patients with pancreas cancer will receive Synthetic Human Secretin during an endoscopy procedure.

Synthetic Human Secretin

Intervention Type: DRUG

Subjects will receive a dose of 0.2ng/kg while the endoscope is positioned in the second portion of the duodenum.

Control Subjects

Controls will receive Synthetic Human Secretin during an endoscopy procedure. Controls are at an elevated risk of pancreas cancer, including pancreatic cystic neoplasms.

Synthetic Human Secretin

Intervention Type: DRUG

Subjects will receive a dose of 0.2ng/kg while the endoscope is positioned in the second portion of the duodenum.

Familial Pancreatic Cancer Subjects

Subjects who have a family history of pancreas cancer will receive Synthetic Human Secretin during an endoscopy procedure.

Synthetic Human Secretin

Intervention Type: DRUG

Subjects will receive a dose of 0.2ng/kg while the endoscope is positioned in the second portion of the duodenum.

Interventions

Synthetic Human Secretin

Subjects will receive a dose of 0.2ng/kg while the endoscope is positioned in the second portion of the duodenum.

Intervention Type: DRUG

Other Intervention Names

ChiRhoStim

Eligibility Criteria

Inclusion Criteria

• Patients who are referred for the evaluation of pancreas cancer, pancreatic cystic neoplasm, and family history of pancreas cancer.
• International normalized ratio (INR) less than 1.5
• Platelet count >50,000

Exclusion Criteria

• Any medical condition that preclude the patient from having a therapeutic procedure regardless of the Endoscopic ultrasound (EUS) finding
• Pregnant patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Massimo Raimondo, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Massimo Raimondo, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

17-005211

Identifier Type: -

Identifier Source: org_study_id