Optical and Biochemical Biomarkers in Early Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Optical and Biochemical Biomarkers in Early Pancreatic Cancer Significance: A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404661
• Other study ID #: 17-005211
• Status: Completed
• Start date: January 11, 2018
• Est. completion date: March 10, 2022

Study information

• Verified date: June 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: March 10, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Synthetic Human Secretin
Subjects will receive a dose of 0.2ng/kg while the endoscope is positioned in the second portion of the duodenum.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Methylated DNA markers as measured by mean percentage of total human DNA per pancreatic juice volume	After pancreatic juice is collected, top 10 markers for pancreas cancer detection will be done from discovery and validation on tissue (AUC>.95) and from pilot pancreatic-juice testing (AUCs >0.9).	one year

External Links

•   Mayo Clinic Clinical Trials