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

Primary Purpose

Pancreatic Cancer, Adenocarcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cytology specimen collection procedure
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Cancer focused on measuring pancreatic cancer, adenocarcinoma, pancreatic resection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (cytopathologic evaluation)

Arm Description

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.

Outcomes

Primary Outcome Measures

Local recurrence at the site of resection
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.

Secondary Outcome Measures

Full Information

First Posted
July 18, 2012
Last Updated
June 8, 2017
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01646697
Brief Title
Slide Interpretation or Standard Surgical Pathology in Assessing Margin Status in Patients With Pancreatic Cancer Undergoing Surgery
Official Title
Cytopathologic Margin Evaluation in Patients Undergoing Pancreatic Cancer Resection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 7, 2011 (Actual)
Primary Completion Date
February 6, 2016 (Actual)
Study Completion Date
February 6, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Adenocarcinoma
Keywords
pancreatic cancer, adenocarcinoma, pancreatic resection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (cytopathologic evaluation)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
cytology specimen collection procedure
Other Intervention Name(s)
cytologic sampling
Intervention Description
Undergo cytopathologic sample collection
Primary Outcome Measure Information:
Title
Local recurrence at the site of resection
Description
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.
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Bloomston, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
Jamesline

Learn more about this trial

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

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