Slide Interpretation or Standard Surgical Pathology in Assessing Margin Status in Patients With Pancreatic Cancer Undergoing Surgery
This study is currently recruiting participants.
Verified April 2013 by Ohio State University Comprehensive Cancer Center
Sponsor:
Ohio State University Comprehensive Cancer Center
Information provided by (Responsible Party):
Mark Bloomston, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01646697
First received: July 18, 2012
Last updated: April 2, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2013 (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
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: | April 2, 2013 |
| 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 Adenocarcinoma, Mucinous Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Cystic, Mucinous, and Serous Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013