Molecular and Cellular Characterization of Skull Base Tumors

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03759717
• Collaborator: (none)
• Enrollment: 4,000
• Location: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 33.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Skull Base Neoplasm; Cellular Pathology	Other: Observation

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
• Anticipated Enrollment: 4000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Molecular and Cellular Characterization of Skull Base Tumors
• Actual Study Start Date: Oct 3, 2018
• Anticipated Primary Completion Date: Oct 3, 2028
• Anticipated Study Completion Date: Oct 3, 2028

Outcome Measures

Primary Outcome Measures

1. Patient overall survival will be measured and reported. [Through study completion, an average of 10 years]

   There will be one outcome measure: overall survival.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Diagnosis of a skull base tumor

Exclusion Criteria:

• Insufficient tumor sample at time of resection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh

Investigators

• Principal Investigator: Paul Gardner, MD, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paul Gardner, Associate Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03759717
• Other Study ID Numbers: 18070686
• First Posted: Nov 30, 2018
• Last Update Posted: Dec 3, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Skull Base Neoplasms

Study Results

No Results Posted as of Dec 3, 2021