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Clinical Trials/NCT03759717
NCT03759717
Recruiting
Not Applicable

Molecular and Cellular Characterization of Skull Base Tumors

University of Pittsburgh1 site in 1 country4,000 target enrollmentStarted: October 3, 2018Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
4,000
Locations
1
Primary Endpoint
Patient overall survival will be measured and reported.

Overview

Brief Summary

The purpose of the study is to analyze biological samples and genetic material for basic science research investigating the molecular and cellular characterization of skull base tumors.

Detailed Description

The overall goal of this proposal is to determine new molecular and cellular features that define tumor subtypes that are clinically actionable, may drive important changes in patient management, and/or elucidate novel chemotherapeutic options. Skull base tumors are currently diagnosed based on histopathologic criteria, on which post-operative management is based. However, the investigators hypothesize that each tumor type (eg. chordoma or chondrosarcoma) will have molecular and/or cellular subcategories that will redefine how to categorize and diagnose patients, predict clinical outcome, and optimally design a patient-specific management strategy. In addition, we aim to catalogue changes that occur after treatment after surgical resection, chemotherapy, and/or radiation by comparing primary and recurrent tumors.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of a skull base tumor

Exclusion Criteria

  • Insufficient tumor sample at time of resection

Outcomes

Primary Outcomes

Patient overall survival will be measured and reported.

Time Frame: Through study completion, an average of 10 years

There will be one outcome measure: overall survival.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Paul Gardner

Associate Professor

University of Pittsburgh

Study Sites (1)

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