- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00949156
Tumor Classification and Its Application in Surgical Treatment of Craniopharyngioma
September 14, 2010 updated by: Southern Medical University, China
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
238
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510515
- Neurosurgery department, Nanfang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
1~2 years
|
After long term follow up of CP patients, the normalized treatment was evaluated and modified.
Time Frame: 3~5 years
|
3~5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Songtao Qi, MD, PhD, Director, Neurosurgery department, Nanfang Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1997
Primary Completion (Actual)
October 1, 2009
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
July 21, 2009
First Submitted That Met QC Criteria
July 29, 2009
First Posted (Estimate)
July 30, 2009
Study Record Updates
Last Update Posted (Estimate)
September 15, 2010
Last Update Submitted That Met QC Criteria
September 14, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMUneurosurgery
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Craniopharyngioma
-
Nationwide Children's HospitalChildren's Hospital ColoradoRecruitingAdamantinous Craniopharyngioma | Recurrent Adamantinomatous CraniopharyngiomaUnited States, United Kingdom, Australia, Canada, Germany, Netherlands
-
Nationwide Children's HospitalChildren's Hospital ColoradoRecruitingAdamantinomatous Craniopharyngioma | Recurrent Adamantinomatous CraniopharyngiomaUnited States, United Kingdom, Australia, Canada, Germany, Netherlands
-
Sabine Mueller, MD, PhDBristol-Myers Squibb; Day One Biopharmaceuticals, Inc.RecruitingCraniopharyngioma | Craniopharyngioma, Child | Recurrent CraniopharyngiomaUnited States
-
University of Colorado, DenverEnrolling by invitationCraniopharyngioma, ChildUnited States
-
BERTHILLIER JulienCompletedChildren With a Craniopharyngioma
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)RecruitingVemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive CraniopharyngiomaBRAF V600E Mutation Present | Papillary CraniopharyngiomaUnited States
-
Pediatric Brain Tumor ConsortiumNational Cancer Institute (NCI)TerminatedChildhood CraniopharyngiomaUnited States
-
University of Colorado, DenverNational Cancer Institute (NCI)Recruiting
-
Huashan HospitalCompletedAdult-onset Craniopharyngioma | Postoperative Weight GainChina
-
Eva Marie Erfurth, MD, PhDNovartisRecruiting