CraniopharyngiomaNCT07342686
Hypothalamic-Stratified Nursing Pathway for Pediatric Craniopharyngioma
An observational study of Craniopharyngioma and Growth Hormone Deficiency (GHD), run by West China Hospital at 1 site in China.
Trial summary
The goal of this multicenter retrospective cohort study is to determine whether MRI-graded hypothalamic injury severity predicts growth-hormone deficiency (GHD) and neuropsychological morbidity in 500 children and adolescents (≤ 18 y) who underwent craniopharyngioma resection at six Chinese pediatric centers between… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Craniopharyngioma, Growth Hormone Deficiency (GHD)
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Study Population Description Children and adolescents ≤ 18 years of age who underwent primary surgical resection for craniopharyngioma at one of six tertiary pediatric centers in China between January 2013 and December 2023, had complete pre- and post-operative brain MRI, endocrine, and neuropsychological data, and were followed for ≥ 2 years without tumor re-operation.
Who may be able to join
- Age ≤18 years at the time of craniopharyngioma resection;
- Pathologically confirmed craniopharyngioma;
- Postoperative follow-up duration ≥2 years;
- Complete preoperative and postoperative MRI data, endocrine test results, neuropsychological assessment records, and nursing documentation;
- No preoperative GHD, neuropsychological disorders, or other systemic diseases affecting growth or neurodevelopment.
Who cannot join
- Preoperative diagnosis of GHD, cognitive impairment, or emotional disorders;
- Concurrent intracranial tumors or systemic diseases (e.g., congenital growth hormone deficiency, Down syndrome);
- Loss to follow-up or incomplete clinical data;
- Tumor recurrence requiring reoperation during follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Hypothalamic Injury-Stratified Nursing Care Pathway for Pediatric Craniopharyngioma Survivors: Advancing Nursing Leadership in Complex Chronic Disease Management
The goal of this multicenter retrospective cohort study is to determine whether MRI-graded hypothalamic injury severity predicts growth-hormone deficiency (GHD) and neuropsychological morbidity in 500 children and adolescents (≤ 18 y) who underwent craniopharyngioma resection at six Chinese pediatric centers between 2013 and 2023 and were followed ≥ 2 years. The main questions it aims to answer are:
- Does increasing hypothalamic injury grade (Grade 0 = uninvolved, Grade 1 = mild compression, Grade 2 = significant invasion) independently correlate with higher incidence of GHD, lower IGF-1 levels, greater height SDS decline, and increased need for recombinant human GH therapy?
- Is higher injury grade associated with worse neuropsychological outcomes-lower IQ, impaired executive function, emotional disorders, and obesity-after adjustment for age, tumor size, and extent of resection?
Researchers compared the three injury-grade groups to quantify endocrine and neuro-behavioral outcomes and to catalog differentiated nursing needs (growth monitoring frequency, dietary-behavioral plans, psychological support intensity, comorbidity surveillance). Participants underwent pre- and post-operative MRI grading by blinded neuroradiologists, standardized endocrine stimulation tests, annual neuropsychological testing (WISC-IV, BRIEF, CBCL), and detailed nursing-documentation review; all data were analyzed with Spearman correlation, ANOVA, and multivariable logistic regression.
- Conditions
- Craniopharyngioma, Growth Hormone Deficiency (GHD)
- Keywords
- Hypothalamic Injury, Neuropsychological Development, Stratified Nursing Pathway, Multicenter Retrospective Study
- Medical subject headings
- Craniopharyngioma, Dwarfism, Pituitary
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 |
|---|---|---|
| Grade 0 | Hypothalamic Injury Uninvolved (n=100) | |
| Grade 1 | Mild Compression (n=250) | |
| Grade 2 | Significant Invasion (n=150) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of growth hormone deficiency (GHD) at 2 years post-surgery
defined as peak GH < 10 ng/mL on stimulation testing plus age-/sex-adjusted IGF-1 below reference range
Measured: 2 years
Secondary outcomes (4)
Change in height standard-deviation score (Δ-height SDS) from baseline to final follow-up.
Measured: 2 years
Proportion of patients who initiate recombinant human GH (rhGH) therapy
Measured: 2 years
Normalized IGF-1 level (age-/sex-adjusted z-score) at final follow-up.
Measured: 2 years
Mean full-scale IQ score (WISC-IV) and rate of cognitive impairment (IQ < 85).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Dec 2023
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniopharyngiomaStudies of the same condition, open and under way.
- More trials run by West China 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhigang Lan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342686
- Sponsor's protocol ID
- WestChinaH-HX-2025-07
- Status last verified
- Jan 2013
- First submitted
- 24 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hypothalamic Injury-Stratified Nursing Care Pathway for Pediatric Craniopharyngioma Survivors: Advancing Nursing Leadership in Complex Chronic Disease Management
- ClinicalTrials.gov ID
- NCT07342686
- Acronym / sponsor ID
- WestChinaH-HX-2025-07
- Conditions
- Craniopharyngioma, Growth Hormone Deficiency (GHD)
- Keywords
- Hypothalamic Injury, Neuropsychological Development, Stratified Nursing Pathway, Multicenter Retrospective Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 15 Jan 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.
The goal of this multicenter retrospective cohort study is to determine whether MRI-graded hypothalamic injury severity predicts growth-hormone deficiency (GHD) and neuropsychological morbidity in 500 children and adolescents (≤ 18 y) who underwent craniopharyngioma resection at six Chinese pediatric centers between 2013 and 2023 and were followed ≥ 2 years. The main questions it aims to answer are:
- Does increasing hypothalamic injury grade (Grade 0 = uninvolved, Grade 1 = mild compression, Grade 2 = significant invasion) independently correlate with higher incidence of GHD, lower IGF-1 levels, greater height SDS decline, and increased need for recombinant human GH therapy?
- Is higher injury grade associated with worse neuropsychological outcomes-lower IQ, impaired executive function, emotional disorders, and obesity-after adjustment for age, tumor size, and extent of resection?
Researchers compared the three injury-grade groups to quantify endocrine and neuro-behavioral outcomes and to catalog differentiated nursing needs (growth monitoring frequency, dietary-behavioral plans, psychological support intensity, comorbidity surveillance). Participants underwent pre- and post-operative MRI grading by blinded neuroradiologists, standardized endocrine stimulation tests, annual neuropsychological testing (WISC-IV, BRIEF, CBCL), and detailed nursing-documentation review; all data were analyzed with Spearman correlation, ANOVA, and multivariable logistic regression.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grade 0 | – | –Hypothalamic Injury Uninvolved (n=100) |
| Grade 1 | – | –Mild Compression (n=250) |
| Grade 2 | – | –Significant Invasion (n=150) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Study Population Description Children and adolescents ≤ 18 years of age who underwent primary surgical resection for craniopharyngioma at one of six tertiary pediatric centers in China between January 2013 and December 2023, had complete pre- and post-operative brain MRI, endocrine, and neuropsychological data, and were followed for ≥ 2 years without tumor re-operation.
Key inclusion criteria (5 listed)
- Age ≤18 years at the time of craniopharyngioma resection;
- Pathologically confirmed craniopharyngioma;
- Postoperative follow-up duration ≥2 years;
- Complete preoperative and postoperative MRI data, endocrine test results, neuropsychological assessment records, and nursing documentation;
- No preoperative GHD, neuropsychological disorders, or other systemic diseases affecting growth or neurodevelopment.
Key exclusion criteria (4 listed)
- Preoperative diagnosis of GHD, cognitive impairment, or emotional disorders;
- Concurrent intracranial tumors or systemic diseases (e.g., congenital growth hormone deficiency, Down syndrome);
- Loss to follow-up or incomplete clinical data;
- Tumor recurrence requiring reoperation during 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
Incidence of growth hormone deficiency (GHD) at 2 years post-surgery
Time frame: 2 years
defined as peak GH < 10 ng/mL on stimulation testing plus age-/sex-adjusted IGF-1 below reference range
4 secondary outcomes
Change in height standard-deviation score (Δ-height SDS) from baseline to final follow-up.
Time frame: 2 years
Proportion of patients who initiate recombinant human GH (rhGH) therapy
Time frame: 2 years
Normalized IGF-1 level (age-/sex-adjusted z-score) at final follow-up.
Time frame: 2 years
Mean full-scale IQ score (WISC-IV) and rate of cognitive impairment (IQ < 85).
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Craniopharyngioma and Growth Hormone Deficiency (GHD), run by West China 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 15 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of growth hormone deficiency (GHD) at 2 years post-surgery (time frame: 2 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 15 Jan 2026.