- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04937335
Craniopharyngioma With Tumoral Hemorrhage
June 21, 2021 updated by: Kai Shu, Tongji Hospital
Clinical Features and Risk Factors of Craniopharyngioma With Tumoral Hemorrhage
Clinical data of 185 consecutive patients receiving resective operation with a pathological diagnosis of craniopharyngioma in our hospital between January 2013 and February 2021 were collected.
Among these patients, 18 of them were recognized as craniopharyngioma with tumoral hemorrhage during the operation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
For each case, age, gender, smoking status, alcohol intake, past history, symptoms, blood pressure, blood cell count, blood biochemical tests, coagulation tests, hormone tests, radiological results, surgical treatment and the outcome at discharge were collected.
The first test result after admission and before the operation was taken for the items of blood tests with multiple times in the analysis.
Study Type
Observational
Enrollment (Actual)
185
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with a pathological diagnosis of craniopharyngioma
Description
Inclusion Criteria:
- receive resective operation with a pathological diagnosis of craniopharyngioma in our hospital
- enter our hospital between January 2013 and February 2021
Exclusion Criteria:
- have a non-craniopharyngioma or unverified pathological diagnosis at discharge
- have received surgical or radiological treatment on the sellar region
- receive treatment of coagulation modulation, immunosuppressive agents or chemotherapeutic drugs
- combine with other clinical emergencies including acute myocardial infarction, cerebral stroke, trauma and sepsis at admission
- have been diagnosed with other tumors, hematological diseases, autoimmune diseases, liver failure or renal failure
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: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Non-hemorrhage group
Patients recognized as craniopharyngioma pathologically without tumoral hemorrhage observed during the operation
|
|
|
Hemorrhage group
Patients recognized as craniopharyngioma pathologically with tumoral hemorrhage observed during the operation
|
Patients who were recognized as craniopharyngioma pathologically with tumoral hemorrhage observed during the operation were enrolled in the hemorrhage group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
craniopharyngioma with tumoral hemorrhage
Time Frame: during the operation
|
Current study is a case-control study whose primary outcome is tumoral hemorrhage observed during the operation, which devided the craniopharyngioma patients into hemorrhage group and non-hemorrhage group.
|
during the operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kai Shu, MD, Tongji Hospital
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 (Actual)
January 1, 2013
Primary Completion (Actual)
February 1, 2021
Study Completion (Actual)
February 1, 2021
Study Registration Dates
First Submitted
June 7, 2021
First Submitted That Met QC Criteria
June 21, 2021
First Posted (Actual)
June 24, 2021
Study Record Updates
Last Update Posted (Actual)
June 24, 2021
Last Update Submitted That Met QC Criteria
June 21, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- kaishu1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Due to the sensitive nature of the questions asked in this study, survey respondents were assured raw data would remain confidential and would not be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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, Australia, Canada
-
Nationwide Children's HospitalChildren's Hospital ColoradoRecruitingAdamantinomatous Craniopharyngioma | Recurrent Adamantinomatous CraniopharyngiomaUnited States, Australia, Canada
-
Sabine Mueller, MD, PhDDay One Biopharmaceuticals, Inc.RecruitingCraniopharyngioma | Craniopharyngioma, Child | Recurrent CraniopharyngiomaUnited States, Australia
-
University of Colorado, DenverEnrolling by invitationCraniopharyngioma, ChildUnited States
-
University of Colorado, DenverNational Cancer Institute (NCI); National Institutes of Health (NIH)Active, not recruiting
-
BERTHILLIER JulienCompletedChildren With a Craniopharyngioma
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not 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
-
Huashan HospitalCompletedAdult-onset Craniopharyngioma | Postoperative Weight GainChina
-
Assistance Publique - Hôpitaux de ParisNot yet recruiting
Clinical Trials on intratumoral hemorrhage
-
Jennifer ZhangAlligator Bioscience ABRecruitingBreast CancerUnited States
-
University of FloridaTerminated
-
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Completed
-
University of ArkansasNot yet recruitingBorderline Resectable/Unresectable Pancreatic Cancer | Non Metastatic Pancreatic Cancer
-
Second Affiliated Hospital, School of Medicine,...RecruitingRadiological Changes of Glymphatic-meningeal Lymphatic Drainage System After Subarachnoid HemorrhageSubarachnoid Hemorrhage | Lymphatic System Disorder | Meningeal Lymphatic VesselsChina
-
Zhou ChengzhiRecruiting
-
Pusan National University HospitalActive, not recruiting
-
Immorna Biotherapeutics, Inc.CompletedMalignant Solid Tumor | Cutaneous TumorChina, United States
-
Pusan National University HospitalCompletedNon Small Cell Lung Cancer | EGFR Gene MutationKorea, Republic of
-
Pusan National University HospitalCompletedLung CancerKorea, Republic of