NCT03759717

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
30mo left

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Oct 2018Oct 2028

Study Start

First participant enrolled

October 3, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 31, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2028

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

10 years

First QC Date

October 31, 2018

Last Update Submit

September 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient overall survival will be measured and reported.

    There will be one outcome measure: overall survival.

    Through study completion, an average of 10 years

Interventions

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.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a skull base tumor

You may qualify if:

  • Diagnosis of a skull base tumor

You may not qualify if:

  • Insufficient tumor sample at time of resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Tissue

MeSH Terms

Conditions

Skull Base Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Skull NeoplasmsBone NeoplasmsNeoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Paul Gardner, MD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benita Valappil, MPH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 30, 2018

Study Start

October 3, 2018

Primary Completion (Estimated)

October 3, 2028

Study Completion (Estimated)

October 3, 2028

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

If data is to be shared it will be de-identified with proper data use agreements in place.

Locations