- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04955535
Screening of Specific Genes for Pigmented Villous Nodular Synovitis
July 7, 2021 updated by: Peking University Third Hospital
This study retrospectively analyzed the history of present illness of PVNS patients in our hospital.
The enrolled patients were followed up by telephone to follow up their postoperative recovery and living conditions.
Take the patient's pathological specimens for immunohistochemical testing, evaluate the relationship between the expression of different molecular targets, clinical manifestations and patient prognosis, and explore new molecular targets related to disease diagnosis and treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study retrospectively analyzed the symptoms, time of onset, injury history, laboratory examinations, imaging examinations, and intraoperative conditions of PVNS patients in our hospital.
The enrolled patients were followed up by telephone to follow up their postoperative recovery and living conditions (VAS score, SF-36 score).
Take the patient's pathological specimens for immunohistochemical testing, evaluate the relationship between the expression of different molecular targets, clinical manifestations and patient prognosis, and explore new molecular targets related to disease diagnosis and treatment.
Study Type
Observational
Enrollment (Actual)
60
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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Beijing
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Beijing, Beijing, China, 100191
- Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries, Beijing, China
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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 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with "pigmented villonodular synovitis" and "giant cell tumor of tendon sheath"
Description
Inclusion Criteria:
- Clinical diagnosis of pigmented villonodular synovitis.
- Clinical diagnosis of giant cell tumor of tendon sheath
Exclusion Criteria:
- No surgical treatment.
- There were no pathological specimens during the operation.
- The age of the patient is less than 18 years old or more than 60 years old.
- The operation record shows nodular type.
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-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference of scale score between immunohistochemistry positive group and negative group
Time Frame: One week after surgery
|
Difference of Visual Analog Score for pain between CSF-1 immunohistochemistry positive group and negative group
|
One week after surgery
|
Difference of Visual Analog Score for pain between TNF-α immunohistochemistry positive group and negative group
Time Frame: One week after surgery
|
Difference of Visual Analog Score for pain between TNF-α immunohistochemistry positive group and negative group
|
One week after surgery
|
Difference of Visual Analog Score for pain between IL-1B immunohistochemistry positive group and negative group
Time Frame: One week after surgery
|
Difference of Visual Analog Score for pain between IL-1B immunohistochemistry positive group and negative group
|
One week after surgery
|
Difference of SF-36 score between CSF-1 immunohistochemistry positive group and negative group
Time Frame: One week after surgery
|
Difference of SF-36 score between CSF-1 immunohistochemistry positive group and negative group
|
One week after surgery
|
Difference of SF-36 score between TNF-α immunohistochemistry positive group and negative group
Time Frame: One week after surgery
|
Difference of SF-36 score between TNF-α immunohistochemistry positive group and negative group
|
One week after surgery
|
Difference of SF-36 score between IL-1B immunohistochemistry positive group and negative group
Time Frame: One week after surgery
|
Difference of SF-36 score between IL-1B immunohistochemistry positive group and negative group
|
One week after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between basic demographic characteristics and scale scores
Time Frame: One week after surgery
|
Correlation between age, gender and scale score
|
One week after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yingfang Ao, Prof., Peking Yniversity Third 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)
August 3, 2020
Primary Completion (Actual)
December 27, 2020
Study Completion (Actual)
December 27, 2020
Study Registration Dates
First Submitted
June 25, 2021
First Submitted That Met QC Criteria
July 7, 2021
First Posted (Actual)
July 8, 2021
Study Record Updates
Last Update Posted (Actual)
July 8, 2021
Last Update Submitted That Met QC Criteria
July 7, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M201947901
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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