Pituitary TumorNCT04087902
Long-Term Longitudinal QoL in Patients Undergoing EEA
An observational study of Pituitary Tumor and Meningioma, run by Ohio State University at 1 site in United States.
Trial summary
This is a prospective longitudinal study to access postoperative 2-year quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Tumor, Meningioma, Rathke Cleft Cysts
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2019to 31 Dec 2027
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who are 18 years of age or older and undergoing surgery via Endoscopic Endonasal Approach.
Who may be able to join
- Patient is scheduled to undergo endoscopic endonasal surgery. Multiple, staged surgeries are not exclusionary
- 18 years of age or older
- The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent
Who cannot join
- Patient is a prisoner
- Patient is not English speaking
- Patient is not expected to survive until the 2-year follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Longitudinal Quality of Life Study in Patients Undergoing Endoscopic Endonasal Skull Base Surgery
This is a prospective longitudinal study to access postoperative 2-year quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base.
Read the detailed description
This is a prospective single-institution longitudinal study to access quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base. Patients will be followed before surgery and up to twenty-four months post-surgery. The primary goal of the study is to assess the alterations to patient quality of life following endoscopic endonasal surgery using modern sinonasal reconstruction techniques. Secondary goals are to better understand the time course of normal healing and patient/procedural risk factors associated with poorer quality of life outcomes.
- Conditions
- Pituitary Tumor, Meningioma, Rathke Cleft Cysts, Chordoma, Chondrosarcoma, Craniopharyngioma
- Keywords
- Endoscopic Endonasal Approach Surgery
- Medical subject headings
- Pituitary Neoplasms, Meningioma, Central Nervous System Cysts, Chordoma, Chondrosarcoma, Craniopharyngioma, Encephalocele, Esthesioneuroblastoma, Olfactory
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS-29 quality of life outcome measures for patients undergoing endoscopic endonasal surgeries.
This study aims to better understand the long-term overall quality of life of patients undergoing endoscopic endonasal surgery using modern sinonasal reconstruction techniques. The PROMIS-29 metric, an overall quality of life metric, will be used to better understand quality of life for patients undergoing this procedure.
Measured: 24-months post-operatively
Secondary outcomes (3)
ASK Nasal-12 questionnaire used to measure normal time of healing for patients undergoing endoscopic endonasal surgery
This study aims to better understand the overall nose function in patients undergoing endoscopic endonasal surgery using modern sinonasal techniques. The ASK Nasal-12 metric is designed to evaluate nose overall nose function such as post-nasal drip, ability to smell, and pain.
Measured: 24 months post-operatively
Number of patients with long-term quality of life risk factors using PROMIS-29
This study aims to better understand the number of long-term risk factors for patients undergoing endoscopic endonasal surgeries using modern sinonasal reconstruction techniques. This will be done using the PROMIS-29 metric along with patient data.
Measured: 24 months post-operatively
Number of patients with long-term procedural comorbidities using ASK-Nasal 12.
This study aims to better understand the number of long-term comorbidities for patients undergoing endonasal endoscopic surgeries using modern sinonasal reconstruction techniques. This will be done using the ASK-Nasal 12 metric along with patient data.
Measured: 24 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start16 Jul 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary TumorStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Wu, Ohio State University
- Investigators
- Kyle Wu, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087902
- Sponsor's protocol ID
- 2019H0225
- Status last verified
- May 2026
- First submitted
- 20 Aug 2019
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no sharing of individual participant data with other researchers. Data will be de-identified once analysis is complete and destroyed once manuscripts are written.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Longitudinal Quality of Life Study in Patients Undergoing Endoscopic Endonasal Skull Base Surgery
- ClinicalTrials.gov ID
- NCT04087902
- Acronym / sponsor ID
- 2019H0225
- Conditions
- Pituitary Tumor, Meningioma, Rathke Cleft Cysts, Chordoma, Chondrosarcoma, Craniopharyngioma
- Keywords
- Endoscopic Endonasal Approach Surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Sep 2019 (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.
This is a prospective longitudinal study to access postoperative 2-year quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base.
Detailed description
This is a prospective single-institution longitudinal study to access quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base. Patients will be followed before surgery and up to twenty-four months post-surgery. The primary goal of the study is to assess the alterations to patient quality of life following endoscopic endonasal surgery using modern sinonasal reconstruction techniques. Secondary goals are to better understand the time course of normal healing and patient/procedural risk factors associated with poorer quality of life outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who are 18 years of age or older and undergoing surgery via Endoscopic Endonasal Approach.
Key inclusion criteria (3 listed)
- Patient is scheduled to undergo endoscopic endonasal surgery. Multiple, staged surgeries are not exclusionary
- 18 years of age or older
- The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent
Key exclusion criteria (3 listed)
- Patient is a prisoner
- Patient is not English speaking
- Patient is not expected to survive until the 2-year follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PROMIS-29 quality of life outcome measures for patients undergoing endoscopic endonasal surgeries.
Time frame: 24-months post-operatively
This study aims to better understand the long-term overall quality of life of patients undergoing endoscopic endonasal surgery using modern sinonasal reconstruction techniques. The PROMIS-29 metric, an overall quality of life metric, will be used to better understand quality of life for patients undergoing this procedure.
3 secondary outcomes
ASK Nasal-12 questionnaire used to measure normal time of healing for patients undergoing endoscopic endonasal surgery
Time frame: 24 months post-operatively
Number of patients with long-term quality of life risk factors using PROMIS-29
Time frame: 24 months post-operatively
Number of patients with long-term procedural comorbidities using ASK-Nasal 12.
Time frame: 24 months post-operatively
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 20 May 2026.
- Individual participant dataSharing planned: No. There will be no sharing of individual participant data with other researchers. Data will be de-identified once analysis is complete and destroyed once manuscripts are written.
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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. This study is not recruiting at the moment.
Kyle Wu, MD principal investigator
Ohio State University
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 Pituitary Tumor and Meningioma, run by Ohio State University 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 20 May 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS-29 quality of life outcome measures for patients undergoing endoscopic endonasal surgeries. (time frame: 24-months post-operatively). 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 20 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.