Molecular and Cellular Characterization of Skull Base Tumors

Skull Base Neoplasm Clinical Trial

Official title:

Molecular and Cellular Characterization of Skull Base Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03759717
• Other study ID #: STUDY19070185
• Status: Recruiting
• Start date: October 3, 2018
• Est. completion date: October 3, 2028

Study information

• Verified date: November 2023
• Source: University of Pittsburgh
• Contact: Benita Valappil, MPH
• Phone: 412-864-1744
• Email: valappilb2[@]upmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: October 3, 2028
• Est. primary completion date: October 3, 2028
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of a skull base tumor

Exclusion Criteria:

• Insufficient tumor sample at time of resection

Related Conditions & MeSH terms

• Cellular Pathology
• Skull Base Neoplasm
• Skull Base Neoplasms

Intervention

Other:
• Observation
Understanding the biology of skull base tumors will teach the investigators about the genesis and/or mechanisms of treatment resistance. The investigators hope to ultimately identify new targets which will add to the armamentarium by which to treat these tumors.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient overall survival will be measured and reported.	There will be one outcome measure: overall survival.	Through study completion, an average of 10 years