CraniopharyngiomaNCT04937335
Craniopharyngioma With Tumoral Hemorrhage
An observational study of Craniopharyngioma and Apoplexy, run by Tongji Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Craniopharyngioma, Apoplexy
- What is being tested?
- intratumoral hemorrhage
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 1 Feb 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with a pathological diagnosis of craniopharyngioma
Who may be able to join
- receive resective operation with a pathological diagnosis of craniopharyngioma in our hospital
- enter our hospital between January 2013 and February 2021
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Craniopharyngioma, Apoplexy
- Being tested
- intratumoral hemorrhage
- Keywords
- craniopharyngioma, endocrine, risk factor, tumoral hemorrhage
- Medical subject headings
- Craniopharyngioma, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intratumoral hemorrhageOther
Patients who were recognized as craniopharyngioma pathologically with tumoral hemorrhage observed during the operation were enrolled in the hemorrhage group.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: intratumoral hemorrhage |
What is being measured
The primary outcome is the main question the study is designed to answer.
craniopharyngioma with tumoral hemorrhage
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.
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Jan 2013
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
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 Tongji 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-control
- Time perspective
- Retrospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Shu, Tongji Hospital
- Investigators
- Kai Shu, MD, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937335
- Sponsor's protocol ID
- kaishu1
- Status last verified
- Jun 2021
- First submitted
- 7 Jun 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features and Risk Factors of Craniopharyngioma With Tumoral Hemorrhage
- ClinicalTrials.gov ID
- NCT04937335
- Acronym / sponsor ID
- kaishu1
- Conditions
- Craniopharyngioma, Apoplexy
- Keywords
- craniopharyngioma, endocrine, risk factor, tumoral hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 24 Jun 2021 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-hemorrhage group | – | –Patients recognized as craniopharyngioma pathologically without tumoral hemorrhage observed during the operation |
| Hemorrhage group | – | Other: intratumoral hemorrhagePatients recognized as craniopharyngioma pathologically with tumoral hemorrhage observed during the operation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with a pathological diagnosis of craniopharyngioma
Key inclusion criteria (2 listed)
- receive resective operation with a pathological diagnosis of craniopharyngioma in our hospital
- enter our hospital between January 2013 and February 2021
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| intratumoral hemorrhagePatients who were recognized as craniopharyngioma pathologically with tumoral hemorrhage observed during the operation were enrolled in the hemorrhage group. | Other | Hemorrhage group |
Primary outcome
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.
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 Jun 2021.
- Individual participant dataSharing planned: No. 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.
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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.
Kai Shu, MD study director
Tongji Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Craniopharyngioma and Apoplexy, run by Tongji Hospital.
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 2 inclusion and 5 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 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
craniopharyngioma with tumoral hemorrhage (time frame: during the operation). 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 Jun 2021.