DNA Microarray Study of Pancreas Cancer

NCT ID: NCT00680420

Last Updated: 2013-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreas Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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fine needle aspiration biopsy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Unable to give informed consent, pregnant or nursing, contraindication to endoscopic ultrasound, no mass or cyst found on ultrasound
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Sarah Rodriguez

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health and Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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IRB4191

Identifier Type: -

Identifier Source: org_study_id

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