Adult-onset CraniopharyngiomaNCT01968603
Weight Gain in Surgically Treated Adult-onset Craniopharyngioma
An observational study of Adult-onset Craniopharyngioma and Postoperative Weight Gain, run by Huashan Hospital at 1 site in China.
Trial summary
The aim of the study was to describe postoperative weight change in adults undergoing surgery for craniopharyngioma and identify preoperative factors associated with it. Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Adult-onset Craniopharyngioma, Postoperative Weight Gain
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Oct 2013
- 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 18 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult-onset patients with craniopharyngioma undertaking primary surgery in the investigators' institution
Who may be able to join
- adult-onset, aged 18 years or more; pathologically confirmed craniopharyngioma; primary surgery performed at our hospital; at least 3 months of follow-up including body weight measurement; ambulatory (since lack of ambulation may predispose to weight gain); not receiving supraphysiologic doses of glucocorticoid (e.g. hydrocortisone, prednisone, or dexamethasone to exceed 12mg/m2•d hydrocortisone equivalent) for more than 2 months after tumor therapy.
Who cannot join
- Childhood-onset, <18 years old; Inconsistent pathology; Without follow-up records in the investigators' institution.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology and Metabolism
Shanghai, Shanghai Municipality, 200040
About this study
The aim of the study was to describe postoperative weight change in adults undergoing surgery for craniopharyngioma and identify preoperative factors associated with it.
Read the detailed description
Morbid obesity, intractable weight gain due to hypothalamic damage, is a common and troubling complication in patients undergoing surgery for craniopharyngioma combined or not with radiotherapy, with an incidence of 23~62% in pediatric patients. It has a major negative impact on metabolic and cardiovascular health and quality of life in long-term survivors. Identifying patients at higher risks for developing postoperative weight gain is of great importance in preventing obesity and taking early actions in this population. Though a lot of previous studies have been made in pediatric patients and several factors, such as hypothalamic involvement, higher body mass index (BMI) standard deviation score (SDS) at diagnosis, age at diagnosis and hydrocephalus requiring a shunt, have been identified as risk factors for postoperative weight gain, data on this important morbidity in adult-onset patients are sparse, especially in Chinese population. Therefore, the investigators are going to undertake a retrospective evaluation of postoperative weight change in adult-onset patients undergoing surgery for craniopharyngioma and identify preoperative factors associated with it.
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of postoperative weight gain
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult-onset CraniopharyngiomaStudies of the same condition, open and under way.
- More trials run by Huashan 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoyun Zhang, Huashan Hospital
- Investigators
- Li yi ming, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968603
- Sponsor's protocol ID
- KY2013-315
- Status last verified
- Oct 2013
- First submitted
- 20 Oct 2013
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Gain in Surgically Treated Adult-onset Craniopharyngioma
- ClinicalTrials.gov ID
- NCT01968603
- Acronym / sponsor ID
- KY2013-315
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 Oct 2013 (estimated)
- 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 aim of the study was to describe postoperative weight change in adults undergoing surgery for craniopharyngioma and identify preoperative factors associated with it.
Detailed description
Morbid obesity, intractable weight gain due to hypothalamic damage, is a common and troubling complication in patients undergoing surgery for craniopharyngioma combined or not with radiotherapy, with an incidence of 23~62% in pediatric patients. It has a major negative impact on metabolic and cardiovascular health and quality of life in long-term survivors. Identifying patients at higher risks for developing postoperative weight gain is of great importance in preventing obesity and taking early actions in this population. Though a lot of previous studies have been made in pediatric patients and several factors, such as hypothalamic involvement, higher body mass index (BMI) standard deviation score (SDS) at diagnosis, age at diagnosis and hydrocephalus requiring a shunt, have been identified as risk factors for postoperative weight gain, data on this important morbidity in adult-onset patients are sparse, especially in Chinese population. Therefore, the investigators are going to undertake a retrospective evaluation of postoperative weight change in adult-onset patients undergoing surgery for craniopharyngioma and identify preoperative factors associated with it.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult-onset patients with craniopharyngioma undertaking primary surgery in the investigators' institution
Key inclusion criteria (1 listed)
- adult-onset, aged 18 years or more; pathologically confirmed craniopharyngioma; primary surgery performed at our hospital; at least 3 months of follow-up including body weight measurement; ambulatory (since lack of ambulation may predispose to weight gain); not receiving supraphysiologic doses of glucocorticoid (e.g. hydrocortisone, prednisone, or dexamethasone to exceed 12mg/m2•d hydrocortisone equivalent) for more than 2 months after tumor therapy.
Key exclusion criteria (1 listed)
- Childhood-onset, <18 years old; Inconsistent pathology; Without follow-up records in the investigators' institution.
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
percentage of postoperative weight gain
Time frame: 2.5 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 24 Oct 2013.
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.
Li yi ming principal investigator
Huashan 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 Adult-onset Craniopharyngioma and Postoperative Weight Gain, run by Huashan 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 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: finished, as of the sponsor's last update on 24 Oct 2013. 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?
percentage of postoperative weight gain (time frame: 2.5 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 24 Oct 2013.