- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04967638
Survival Analysis of Oral Cancer Patients
July 15, 2021 updated by: Hongyang Ma, KU Leuven
Survival Analysis of Segmental Mandibulectomy With Immediate Vascularized Fibula Flap Reconstruction in Stage IV Oral Squamous Cell Carcinoma Patients
This study aims to assess the survival rate of oral squamous cell carcinoma (OSCC) patients following immediate mandibular reconstruction with vascularized fibula flap (VFF) and to identify risk factors influencing the overall survival rate and postoperative outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
74
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
-
-
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Leuven, Belgium
- UZ Leuven
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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
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The files of patients diagnosed and treated between January 1996 to June 2019 for OSCC were retrospectively reviewed.
The patients who underwent primary ablative tumor resection with segmental mandibulectomy and immediate VFF reconstruction were retrieved from the database
Description
Inclusion Criteria:
- Clinical diagnosis of stage IV OSCC
- Follow-up period more than one year.
Exclusion Criteria:
- Non-neoplastic diseases
- Two-staged reconstruction
- Presurgical distant metastasis
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The overall cumulative survival
Time Frame: 5th year
|
The overall cumulative survival was recorded at the fifth-year.
|
5th year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
June 1, 2020
Primary Completion (Actual)
September 1, 2020
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
July 7, 2021
First Submitted That Met QC Criteria
July 15, 2021
First Posted (Actual)
July 19, 2021
Study Record Updates
Last Update Posted (Actual)
July 19, 2021
Last Update Submitted That Met QC Criteria
July 15, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S63615-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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