Pituitary Neuroendocrine TumorsNCT07835412
A Comparative Study of Patients Undergoing Surgery for Pituitary Neuroendocrine Tumors Detected by Different Ways
An observational study of Pituitary Neuroendocrine Tumors, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This multicenter cohort study is based on the National Brain Tumor Registry of China (NBTRC). It will compare patients who underwent surgery for Pituitary Neuroendocrine Tumors (PitNETs) detected through health screening versus those diagnosed via outpatient consultations. Read more about this study
- Who is it for?
- Ages 1 year to 85 years
- Conditions the study is for
- Pituitary Neuroendocrine Tumors
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2026to 30 Sep 2026
- 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 1 year to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with PitNETs who underwent surgical resection at Beijing Tiantan Hospital from September 1, 2011, to November 30, 2019, together with those recorded in the NBTRC who underwent surgery from December 1, 2019, to December 31, 2021.
Who may be able to join
- Patients with PitNETs who underwent surgical resection at Beijing Tiantan Hospital from September 1, 2011, to November 30, 2019, together with those recorded in the NBTRC who underwent surgery from December 1, 2019, to December 31, 2021.
Who cannot join
- The department (health screening or outpatient clinics) where the definitive diagnosis confirmed was missing or unclear
- PitNETs was recurrent or synchronous brain tumors of any histology existed
- Admission was via the emergency department
- Maximum tumor diameter on preoperative MRI were unavailable
- Patients who explicitly declined to participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Deling Li contact
China1 site, 1 recruiting
- Recruiting
the National Brain Tumor Registry of China (NBTRC)
Beijing, Beijing Municipality, 100070
Luwen Zhang, +86 13051518751, zhangluwen47@163.com
Deling Li, lideling@bjtth.org
About this study
Official title: Role of Health Screening in Patients Undergoing Surgery for Pituitary Neuroendocrine Tumors: A Multicenter Cohort Study From the National Brain Tumor Registry of China (NBTRC)
This multicenter cohort study is based on the National Brain Tumor Registry of China (NBTRC). It will compare patients who underwent surgery for Pituitary Neuroendocrine Tumors (PitNETs) detected through health screening versus those diagnosed via outpatient consultations. The study will evaluate differences between the two groups in surgical metrics, patient-centered outcomes, and healthcare utilization.
Read the detailed description
This multicenter cohort study is based on the National Brain Tumor Registry of China (NBTRC), a nationwide brain tumor registry established by the China National Clinical Research Center for Neurological Diseases.
Patients will be categorized according to their initial consultation department. The screening group will include patients whose tumors were incidentally detected during health screening. The clinical group will include patients diagnosed through outpatient consultations, which will be further subdivided into neurosurgery, ear-nose-throat/ophthalmology, other surgical specialties, and internal medicine. Group assignment will be determined by reviewing each patient's chief complaint, present illness, and past medical history.
The primary outcomes include surgery-related measures (preoperative maximum tumor diameter and extent of resection, defined as gross total resection) and patient-centered outcomes (preoperative symptom phenotype, time from symptom onset to surgery, and postoperative hormonal remission status before discharge). Secondary outcomes reflect socioeconomic burden, including operation duration, length of stay, and total hospitalization costs.
Subgroup analyses will be performed according to functional hormone subtypes. In addition to the two-group comparison between screening and clinical groups, multi-group comparisons will be conducted across different initial consultation departments, with the screening group serving as the reference. Multivariable regression models will be used to adjust for potential confounders, including age, sex, hormone type, insurance status, and hospital-level clustering.
- Conditions
- Pituitary Neuroendocrine Tumors
- Keywords
- Pituitary Neuroendocrine Tumors, Health Screening, Patient-Centered, Hormone Remission, Extent of Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clinical group | Tumors were diagnosed at outpatient clinics. For patients in the clinical group, the Initial Consultation Departments will included Neurosurgery, Ear, nose and throat/Ophthalmology, Other surgical specialties, and Internal Medicine. | |
| Screening group | Tumors were detected by health screening. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative maximum tumor diameter
Maximum tumor diameter in millimeters, measured on preoperative Magnetic Resonance Imaging (MRI), defined as the largest dimension of the tumor.
Measured: Within 3 months before surgery
Extent of resection
Gross total resection (GTR) versus non-GTR, assessed by intraoperative findings combined with MRI performed within 72 hours after surgery.
Measured: Within 72 hours after surgery
Preoperative symptom phenotype
Presence or absence of preoperative symptoms (including visual decline, headache, hyperpituitarism, hypopituitarism, diplopia, cerebrospinal fluid leak, nonspecific symptoms, and other symptoms) reported by the patient at hospital admission, reflecting symptoms experienced during the preoperative period.
Measured: At hospital admission
Time interval from symptom onset to surgery
Time in months from the date of symptom onset to the date of surgery, calculated from patient-reported history documented in medical records.
Measured: At hospital admission
Postoperative hormone remission status
Biochemical remission of functioning adenomas (Prolactin [PRL], Growth Hormone [GH], Adrenocorticotropic Hormone [ACTH], Thyroid-Stimulating Hormone [TSH]) assessed before hospital discharge, based on disease-specific criteria per Endocrine Society guidelines.
Measured: At hospital discharge
Secondary outcomes (3)
Length of hospital stay
Number of days from admission to discharge, calculated from medical records.
Measured: At hospital discharge
Operation duration
Total time of surgery, measured from the start to the end of the procedure, extracted from surgical records.
Measured: At the end of surgery
Total hospitalization costs
Total inpatient expenses in Chinese Yuan (CNY) during the index admission, including all medical services, medications, imaging, laboratory tests, and surgical fees, extracted from hospital billing records.
Measured: At hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start22 Sep 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang Jia, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835412
- Sponsor's protocol ID
- Youth Beijing Scholar 2022.053
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision on whether to share individual participant data (IPD) has not yet been finalized. Data sharing will be considered in accordance with institutional policies, patient consent, and Chinese regulatory requirements. Any future sharing would require additional ethical approval and a data transfer agreement.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Health Screening in Patients Undergoing Surgery for Pituitary Neuroendocrine Tumors: A Multicenter Cohort Study From the National Brain Tumor Registry of China (NBTRC)
- ClinicalTrials.gov ID
- NCT07835412
- Acronym / sponsor ID
- Youth Beijing Scholar 2022.053
- Conditions
- Pituitary Neuroendocrine Tumors
- Keywords
- Pituitary Neuroendocrine Tumors, Health Screening, Patient-Centered, Hormone Remission, Extent of Resection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 22 Sep 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 22 Sep 2026 (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 multicenter cohort study is based on the National Brain Tumor Registry of China (NBTRC). It will compare patients who underwent surgery for Pituitary Neuroendocrine Tumors (PitNETs) detected through health screening versus those diagnosed via outpatient consultations. The study will evaluate differences between the two groups in surgical metrics, patient-centered outcomes, and healthcare utilization.
Detailed description
This multicenter cohort study is based on the National Brain Tumor Registry of China (NBTRC), a nationwide brain tumor registry established by the China National Clinical Research Center for Neurological Diseases.
Patients will be categorized according to their initial consultation department. The screening group will include patients whose tumors were incidentally detected during health screening. The clinical group will include patients diagnosed through outpatient consultations, which will be further subdivided into neurosurgery, ear-nose-throat/ophthalmology, other surgical specialties, and internal medicine. Group assignment will be determined by reviewing each patient's chief complaint, present illness, and past medical history.
The primary outcomes include surgery-related measures (preoperative maximum tumor diameter and extent of resection, defined as gross total resection) and patient-centered outcomes (preoperative symptom phenotype, time from symptom onset to surgery, and postoperative hormonal remission status before discharge). Secondary outcomes reflect socioeconomic burden, including operation duration, length of stay, and total hospitalization costs.
Subgroup analyses will be performed according to functional hormone subtypes. In addition to the two-group comparison between screening and clinical groups, multi-group comparisons will be conducted across different initial consultation departments, with the screening group serving as the reference. Multivariable regression models will be used to adjust for potential confounders, including age, sex, hormone type, insurance status, and hospital-level clustering.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical group | – | –Tumors were diagnosed at outpatient clinics. For patients in the clinical group, the Initial Consultation Departments will included Neurosurgery, Ear, nose and throat/Ophthalmology, Other surgical specialties, and Internal Medicine. |
| Screening group | – | –Tumors were detected by health screening. |
Who may qualify
- Ages
- 1 year to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with PitNETs who underwent surgical resection at Beijing Tiantan Hospital from September 1, 2011, to November 30, 2019, together with those recorded in the NBTRC who underwent surgery from December 1, 2019, to December 31, 2021.
Key inclusion criteria (1 listed)
- Patients with PitNETs who underwent surgical resection at Beijing Tiantan Hospital from September 1, 2011, to November 30, 2019, together with those recorded in the NBTRC who underwent surgery from December 1, 2019, to December 31, 2021.
Key exclusion criteria (5 listed)
- The department (health screening or outpatient clinics) where the definitive diagnosis confirmed was missing or unclear
- PitNETs was recurrent or synchronous brain tumors of any histology existed
- Admission was via the emergency department
- Maximum tumor diameter on preoperative MRI were unavailable
- Patients who explicitly declined to participate in this study
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
Preoperative maximum tumor diameter
Time frame: Within 3 months before surgery
Maximum tumor diameter in millimeters, measured on preoperative Magnetic Resonance Imaging (MRI), defined as the largest dimension of the tumor.
Extent of resection
Time frame: Within 72 hours after surgery
Gross total resection (GTR) versus non-GTR, assessed by intraoperative findings combined with MRI performed within 72 hours after surgery.
Preoperative symptom phenotype
Time frame: At hospital admission
Presence or absence of preoperative symptoms (including visual decline, headache, hyperpituitarism, hypopituitarism, diplopia, cerebrospinal fluid leak, nonspecific symptoms, and other symptoms) reported by the patient at hospital admission, reflecting symptoms experienced during the preoperative period.
Time interval from symptom onset to surgery
Time frame: At hospital admission
Time in months from the date of symptom onset to the date of surgery, calculated from patient-reported history documented in medical records.
Postoperative hormone remission status
Time frame: At hospital discharge
Biochemical remission of functioning adenomas (Prolactin [PRL], Growth Hormone [GH], Adrenocorticotropic Hormone [ACTH], Thyroid-Stimulating Hormone [TSH]) assessed before hospital discharge, based on disease-specific criteria per Endocrine Society guidelines.
3 secondary outcomes
Length of hospital stay
Time frame: At hospital discharge
Operation duration
Time frame: At the end of surgery
Total hospitalization costs
Time frame: At hospital discharge
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 30 Sep 2026.
- Individual participant dataSharing planned: Undecided. The decision on whether to share individual participant data (IPD) has not yet been finalized. Data sharing will be considered in accordance with institutional policies, patient consent, and Chinese regulatory requirements. Any future sharing would require additional ethical approval and a data transfer agreement.
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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.
Deling Li contact
Wang Jia principal investigator
Beijing Tiantan Hospital
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 Neuroendocrine Tumors, run by Beijing Tiantan Hospital at 1 site in China.
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 5 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 30 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 China. 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 Luwen Zhang (+86 13051518751, zhangluwen47@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative maximum tumor diameter (time frame: Within 3 months before surgery). The study lists 5 primary outcomes in all. 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 30 Sep 2026.