Molecular and Cellular Characterization of Skull Base Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Skull Base Neoplasm; Cellular Pathology
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Benita Valappil, MPH; Phone Number: 412-864-1744; Email: valappilb2@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center
      • Contact: Benita Valappil, MPH; Phone Number: 412-864-1744; Email: valappilb2@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with a skull base tumor

Description

Inclusion Criteria:

• Diagnosis of a skull base tumor

Exclusion Criteria:

• Insufficient tumor sample at time of resection

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient overall survival will be measured and reported.	There will be one outcome measure: overall survival.	Through study completion, an average of 10 years

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Paul Gardner, MD, Associate professor

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2018
• Primary Completion (Estimated): October 3, 2028
• Study Completion (Estimated): October 3, 2028

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): November 30, 2018

Study Record Updates

• Last Update Posted (Estimated): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Neoplasms by Site; Neoplasms; Bone Neoplasms; Skull Neoplasms; Skull Base Neoplasms; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: STUDY19070185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: If data is to be shared it will be de-identified with proper data use agreements in place.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No