CraniopharyngiomaNCT00949156
Tumor Classification and Its Application in Surgical Treatment of Craniopharyngioma
An observational study of Craniopharyngioma, run by Southern Medical University, China at 1 site in China.
Trial summary
With the preliminary anatomical and histological study, the membranous structures of the sellar region was considered to be closely related with the growth pattern of Craniopharyngiomas(CP). Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Craniopharyngioma
- What is being tested?
- Different surgical approach and techniques being used to treat three subtype of CP
- Type of treatment
- Surgery or procedure
- How many people
- 238 participants
- Where
- 1 siteChina
- Study dates
- Sep 1997to Dec 2015
- 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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The clinical data of 198 patients who underwent primary microsurgery for craniopharyngiomas at our institute since July, 1997 until now was analysed retrospectively. The anticipated 40 CP patients in the following two years were recurited in the prospective cohort, who will be surgical treated according to the standard process.
Who may be able to join
- Primary craniopharyngioma(initial diagnosis);
- The sufficient pre-, intra and postoperative information (including patient's information, presenting manifestation, the pre- and postsurgical MRI, CT; Intrasurgical image, and endocrine data);
- After surgery, patients are followed periodically. Quality of life is assessed at baseline and then periodically thereafter.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Neurosurgery department, Nanfang hospital
Guangzhou, Guangdong, 510515
About this study
With the preliminary anatomical and histological study, the membranous structures of the sellar region was considered to be closely related with the growth pattern of Craniopharyngiomas(CP). By combined considering of the tumor-membrane relationship, this project was trying to classify the CP through retrospectively summarizing the pre- and postoperative imaging (MRI and CT), the intrasurgical findings, and the endocrine data of 198 CPs with primary surgery in our hospital (since 1997 until now). As a result, a distinct and systematic CP classification was proposed. The possible originate site, surgical skills and postoperative treatment of all the subtype tumors were discussed and analyzed to provide a normalized surgical treatment for this kind of tumor. Then in the prospective cohort, the anticipated 100 CP patients will accept the normalized surgical treatment. And by the long term follow up, the postsurgical quantity of life (QOL) of patients was evaluated with aspect in cognition, circadian rhythm, endocrine, Water-Electrolyte and body weight, et al. By comparing with the long-term results of the retrospective cohort, the totally follow up data was statistically analyzed to assess the rationality of this standard treatment of CP.
- Conditions
- Craniopharyngioma
- Being tested
- Different surgical approach and techniques being used to treat three subtype of CP
- Keywords
- Craniopharyngiomas, Classification, Membranous structure, Pituitary stalk, Obesity, panhypopituitarism
- Medical subject headings
- Craniopharyngioma, Obesity, Combined Pituitary Hormone Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different surgical approach and techniques being used to treat three subtype of CPProcedure or surgery
According to the presurgical MRI, with the analysis of the morphological characteristic of three subtype of CP, different surgical approach and intrasurgical skills were used to treat tumors with trying to total remove tumor and avoid the hypothalamus injury.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | The 198 cases of CP with primary surgery in our hospital (since July, 1997 until now) were divided into three topographical groups based on the pre-operative MRI, intraoperative findings and the tumor-membrane relationship. The presurgical manifestation, the different surgical approach, intraoperative techniques, and postoperative complication were described and analyzed to establish a normalized surgical treatment of individual CP patient, which has the highest rate of the totally tumoral resection and the lowest rate of the hypothalamic injury. | |
| Prospective cohort | The anticipated 40 cases of CP were surgical treated by our standard procedure, which is recruited in the prospective cohort. With the long-term follow up, QOL including the cognition, circadian rhythm, endocrine, Water-Electrolyte, and body weight et al were evaluated to assess the rationality of the treatment. Then according to the results, the surgical treatment was modified, and the endocrinic substitution therapy was also been developed. Receives: Procedure: Different surgical approach and techniques being used to treat three subtype of CP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The course of suprasellar arachnoid mater and pia mater, and the construction of all meninges of the sellar region was observed and measured by microscopy.
Measured: 1~2 years
Through the analysis of the pre- and postoperative imaging and intrasurgical findings of CP, and combined considering of the tumor-membrane relationship, the classification of CP was proposed.
Measured: 1~2 years
After long term follow up of CP patients, the normalized treatment was evaluated and modified.
Measured: 3~5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startSep 1997
- Primary completionOct 2009
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CraniopharyngiomaStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Medical University, China
- Sponsor type
- University, hospital or other
- Investigators
- Songtao Qi, MD, PhD, Principal investigator, Director, Neurosurgery department, Nanfang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949156
- Sponsor's protocol ID
- SMUneurosurgery
- Status last verified
- Sep 2010
- First submitted
- 21 Jul 2009
- Last updated
- 15 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Peng JX, Yang L, Huang GL, Liu Y, Zhang SC, Pan J, Qi ST. Development of a novel score to predict probability of growth without growth hormone after resection of paediatric craniopharyngiomas: relative to tumour growth pattern. J Endocrinol Invest. 2020 Jun;43(6):737-747. doi: 10.1007/s40618-019-01154-y. Epub 2019 Dec 18.
PubMed 31853886
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Classification and Its Application in Surgical Treatment of Craniopharyngioma
- ClinicalTrials.gov ID
- NCT00949156
- Acronym / sponsor ID
- SMUneurosurgery
- Conditions
- Craniopharyngioma
- Keywords
- Craniopharyngiomas, Classification, Membranous structure, Pituitary stalk, Obesity, panhypopituitarism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Southern Medical University, ChinaUniversity, hospital or other
- Study start
- Sep 1997
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Jul 2009 (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.
With the preliminary anatomical and histological study, the membranous structures of the sellar region was considered to be closely related with the growth pattern of Craniopharyngiomas(CP). By combined considering of the tumor-membrane relationship, this project was trying to classify the CP through retrospectively summarizing the pre- and postoperative imaging (MRI and CT), the intrasurgical findings, and the endocrine data of 198 CPs with primary surgery in our hospital (since 1997 until now). As a result, a distinct and systematic CP classification was proposed. The possible originate site, surgical skills and postoperative treatment of all the subtype tumors were discussed and analyzed to provide a normalized surgical treatment for this kind of tumor. Then in the prospective cohort, the anticipated 100 CP patients will accept the normalized surgical treatment. And by the long term follow up, the postsurgical quantity of life (QOL) of patients was evaluated with aspect in cognition, circadian rhythm, endocrine, Water-Electrolyte and body weight, et al. By comparing with the long-term results of the retrospective cohort, the totally follow up data was statistically analyzed to assess the rationality of this standard treatment of CP.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | –The 198 cases of CP with primary surgery in our hospital (since July, 1997 until now) were divided into three topographical groups based on the pre-operative MRI, intraoperative findings and the tumor-membrane relationship. The presurgical manifestation, the different surgical approach, intraoperative techniques, and postoperative complication were described and analyzed to establish a normalized surgical treatment of individual CP patient, which has the highest rate of the totally tumoral resection and the lowest rate of the hypothalamic injury. |
| Prospective cohort | – | Procedure: Different surgical approach and techniques being used to treat three subtype of CPThe anticipated 40 cases of CP were surgical treated by our standard procedure, which is recruited in the prospective cohort. With the long-term follow up, QOL including the cognition, circadian rhythm, endocrine, Water-Electrolyte, and body weight et al were evaluated to assess the rationality of the treatment. Then according to the results, the surgical treatment was modified, and the endocrinic substitution therapy was also been developed. |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The clinical data of 198 patients who underwent primary microsurgery for craniopharyngiomas at our institute since July, 1997 until now was analysed retrospectively. The anticipated 40 CP patients in the following two years were recurited in the prospective cohort, who will be surgical treated according to the standard process.
Key inclusion criteria (3 listed)
- Primary craniopharyngioma(initial diagnosis);
- The sufficient pre-, intra and postoperative information (including patient's information, presenting manifestation, the pre- and postsurgical MRI, CT; Intrasurgical image, and endocrine data);
- After surgery, patients are followed periodically. Quality of life is assessed at baseline and then periodically thereafter.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Different surgical approach and techniques being used to treat three subtype of CPAccording to the presurgical MRI, with the analysis of the morphological characteristic of three subtype of CP, different surgical approach and intrasurgical skills were used to treat tumors with trying to total remove tumor and avoid the hypothalamus injury. | Procedure or surgery | Prospective cohort |
Primary outcome
The course of suprasellar arachnoid mater and pia mater, and the construction of all meninges of the sellar region was observed and measured by microscopy.
Time frame: 1~2 years
Through the analysis of the pre- and postoperative imaging and intrasurgical findings of CP, and combined considering of the tumor-membrane relationship, the classification of CP was proposed.
Time frame: 1~2 years
After long term follow up of CP patients, the normalized treatment was evaluated and modified.
Time frame: 3~5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2010.
- Derived from this study: PubMed 31853886Peng JX, Yang L, Huang GL, Liu Y, Zhang SC, Pan J, Qi ST. Development of a novel score to predict probability of growth without growth hormone after resection of paediatric craniopharyngiomas: relative to tumour growth pattern. J Endocrinol Invest. 2020 Jun;43(6):737-747. doi: 10.1007/s40618-019-01154-y. Epub 2019 Dec 18.
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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.
Songtao Qi, MD, PhD principal investigator
Director, Neurosurgery department, Nanfang 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 Craniopharyngioma, run by Southern Medical University, China 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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 15 Sep 2010. 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?
Results are not available in the source record.
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?
The course of suprasellar arachnoid mater and pia mater, and the construction of all meninges of the sellar region was observed and measured by microscopy. (time frame: 1~2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00949156, which also lists 1 linked publication.
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 Sep 2010.