Optical and Biochemical Biomarkers in Early Pancreatic Cancer

NCT03404661 | Completed FDA Drug

• 1 other identifier: 17-005211
• Study Type: observational
• Target: 346
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Pancreas Cancer Subjects

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

Drug: Synthetic Human Secretin

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.

Drug: Synthetic Human Secretin

Familial Pancreatic Cancer Subjects

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

Drug: Synthetic Human Secretin

Interventions

Synthetic Human Secretin DRUG

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

Also known as: ChiRhoStim

Control Subjects; Familial Pancreatic Cancer Subjects; Pancreas Cancer Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pancreas cancer, controls at an elevated risk of pancreas cancer, including pancreatic cystic neoplasms, and subjects with a familial history of pancreas cancer.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

20cc of venous blood In case of pancreatic cyst, excess fluid above 2cc Excess tumor tissue including portions of cancer and normal tissue

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Secretin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Massimo Raimondo, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 19, 2018
• Study Start: January 11, 2018
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: June 6, 2023

Record last verified: 2023-06

Locations

US (1)