DNA Microarray Study of Pancreas Cancer

NCT00680420 | Completed DMC

• 1 other identifier: IRB4191
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreas cancer and precancerous cysts can be difficult to diagnose. Sometimes biopsies do not show cancer when cancer is actually present. We hypothesize that genetic differences exist in tissue that is malignant compared to nonmalignant. When patients present with a pancreas mass or cyst, we biopsy it by fine-needle aspiration during upper endoscopy with ultrasound guidance. We would like to use tissue obtained via endoscopic ultrasound guided fine needle aspiration to perform DNA microarray analysis, and compare the differences in gene expression level in the benign tissue compared to cancerous tissue in order to improve our diagnostic capabilities. DNA microarray measures gene expression level rather than germline mutations. The true diagnosis will be based on cytology, surgical pathology, or clinical followup. The performance of the microarray test as a diagnostic test will be compared to the performance of cytology.

Conditions

Pancreas Cancer

Keywords

pancreas cancer; pancreas cyst; DNA microarray

Outcome Measures

Primary Outcomes (1)

• Gene expression profile is 95% accurate in diagnosis of malignancy

  after enrollment of 50 patients

Interventions

fine needle aspiration biopsy PROCEDURE

One extra biopsy will be taken from the pancreas only in patients who are already undergoing biopsy of a mass or cyst.

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 suspected pancreas mass

You may qualify if:

• Adults aged 18 or older who are able to give informed consent who present for an endoscopic ultrasound to evaluate a pancreas mass or cyst or for suspicion of cancer.

You may not qualify if:

• Unable to give informed consent, pregnant or nursing, contraindication to endoscopic ultrasound, no mass or cyst found on ultrasound

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Cyst

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Sarah Rodriguez, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 20, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2011
• Last Updated: March 7, 2013

Record last verified: 2013-03

Locations

US (1)