NCT04937335

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

8.1 years

First QC Date

June 7, 2021

Last Update Submit

June 21, 2021

Conditions

Keywords

craniopharyngiomaendocrinerisk factortumoral hemorrhage

Outcome Measures

Primary Outcomes (1)

  • 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.

    during the operation

Study Arms (2)

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

Other: intratumoral hemorrhage

Interventions

Patients who were recognized as craniopharyngioma pathologically with tumoral hemorrhage observed during the operation were enrolled in the hemorrhage group.

Hemorrhage group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with a pathological diagnosis of craniopharyngioma

You may qualify if:

  • receive resective operation with a pathological diagnosis of craniopharyngioma in our hospital
  • enter our hospital between January 2013 and February 2021

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CraniopharyngiomaStroke

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kai Shu, MD

    Tongji Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 24, 2021

Study Start

January 1, 2013

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

June 24, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

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.