Skull Base NeoplasmNCT03759717
Molecular and Cellular Characterization of Skull Base Tumors
An observational study of Skull Base Neoplasm and Cellular Pathology, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skull Base Neoplasm, Cellular Pathology
- What is being tested?
- Observation
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2018to 3 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with a skull base tumor
Who may be able to join
- Diagnosis of a skull base tumor
Who cannot join
- Insufficient tumor sample at time of resection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Benita Valappil, MPH, 412-864-1744, valappilb2@upmc.edu
About this study
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.
Read the 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.
- Conditions
- Skull Base Neoplasm, Cellular Pathology
- Being tested
- Observation
- Medical subject headings
- Skull Base Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient overall survival will be measured and reported.
There will be one outcome measure: overall survival.
Measured: Through study completion, an average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start3 Oct 2018
- Primary completion3 Oct 2028 (estimated)
- Study completion3 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skull Base NeoplasmStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Zenonos, University of Pittsburgh
- Investigators
- Paul Gardner, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759717
- Sponsor's protocol ID
- STUDY19070185
- Status last verified
- Sep 2026
- First submitted
- 31 Oct 2018
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If data is to be shared it will be de-identified with proper data use agreements in place.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Cellular Characterization of Skull Base Tumors
- ClinicalTrials.gov ID
- NCT03759717
- Acronym / sponsor ID
- STUDY19070185
- Conditions
- Skull Base Neoplasm, Cellular Pathology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 3 Oct 2028 (estimated)
- Study completion
- 3 Oct 2028 (estimated)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a skull base tumor
Key inclusion criteria (1 listed)
- Diagnosis of a skull base tumor
Key exclusion criteria (1 listed)
- Insufficient tumor sample at time of resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationUnderstanding 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. | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. If data is to be shared it will be de-identified with proper data use agreements in place.
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Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Gardner, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skull Base Neoplasm and Cellular Pathology, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benita Valappil, MPH (412-864-1744, valappilb2@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient overall survival will be measured and reported. (time frame: Through study completion, an average of 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.