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Slide Interpretation or Standard Surgical Pathology in Assessing Margin Status in Patients With Pancreatic Cancer Undergoing Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Mark Bloomston, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01646697
First received: July 18, 2012
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

This study is being done to investigate another way of evaluating margin status after pancreatectomy by using cytopathology (slide interpretation) as compared to the traditional method of surgical pathology


Condition Intervention
Pancreatic Cancer
Adenocarcinoma
Other: cytology specimen collection procedure

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Cytopathologic Margin Evaluation in Patients Undergoing Pancreatic Cancer Resection

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Local recurrence at the site of resection [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Will be evaluated in a Cox proportion hazards regression model. The prognostic ability of the histological reporting of the specimen margin as well as the cytopathological reporting of the specimen and in situ margins will be evaluated.


Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (cytopathologic evaluation)
Patients undergo cytopathologic sample collection during pancreatic resection during which slides are gently pressed against the cut edge of the pancreas, the surgical bed, and along the superior mesenteric artery, and finally against the tumor itself.
Other: cytology specimen collection procedure
Undergo cytopathologic sample collection
Other Name: cytologic sampling

Detailed Description:

PRIMARY OBJECTIVES:

I. To compare margin status on final pathology with margin status from cytopathologic evaluation.

OUTLINE:

Patients undergo cytopathologic sample collection during pancreatic resection during which slides are gently pressed against the cut edge of the pancreas, the surgical bed, and along the superior mesenteric artery, and finally against the tumor itself.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing pancreatic resection for a presumed, although not necessarily biopsy-proven pancreatic malignancy,
  • ages 18 years to 80 years old

Exclusion Criteria:

  • Pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646697

Contacts
Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Mark Bloomston, MD 614-293-8843 Mark.bloomston@osumc.edu

Locations
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Mark Bloomston, MD    614-293-8843    Mark.Bloomston@osumc.edu   
Principal Investigator: Mark Bloomston         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Mark Bloomston Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: Mark Bloomston, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01646697     History of Changes
Other Study ID Numbers: OSU-10110, NCI-2012-00926
Study First Received: July 18, 2012
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
pancreatic cancer
adenocarcinoma
pancreatic resection

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 27, 2014