Screening of Specific Genes for Pigmented Villous Nodular Synovitis

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04955535
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Actual Duration (Months): 4.8
• Patients Per Site Per Month: 12.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pigmented Villonodular Synovitis	Procedure: Arthroscopic synovectomy

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 Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Screening of Specific Genes for Pigmented Villous Nodular Synovitis
• Actual Study Start Date: Aug 3, 2020
• Actual Primary Completion Date: Dec 27, 2020
• Actual Study Completion Date: Dec 27, 2020

Outcome Measures

Primary Outcome Measures

1. Difference of scale score between immunohistochemistry positive group and negative group [One week after surgery]

   Difference of Visual Analog Score for pain between CSF-1 immunohistochemistry positive group and negative group

2. 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 TNF-α immunohistochemistry positive group and negative group

3. Difference of Visual Analog Score for pain between IL-1B 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

4. Difference of SF-36 score between CSF-1 immunohistochemistry positive group and negative group [One week after surgery]

   Difference of SF-36 score between CSF-1 immunohistochemistry positive group and negative group

5. Difference of SF-36 score between TNF-α immunohistochemistry positive group and negative group [One week after surgery]

   Difference of SF-36 score between TNF-α immunohistochemistry positive group and negative group

6. Difference of SF-36 score between IL-1B immunohistochemistry positive group and negative group [One week after surgery]

   Difference of SF-36 score between IL-1B immunohistochemistry positive group and negative group

Secondary Outcome Measures

1. Correlation between basic demographic characteristics and scale scores [One week after surgery]

   Correlation between age, gender and scale score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Clinical diagnosis of pigmented villonodular synovitis.

2. Clinical diagnosis of giant cell tumor of tendon sheath

Exclusion Criteria:

1. No surgical treatment.

2. There were no pathological specimens during the operation.

3. The age of the patient is less than 18 years old or more than 60 years old.

4. The operation record shows nodular type.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China	Beijing	Beijing	China	100191

Sponsors and Collaborators

• Peking University Third Hospital

Investigators

• Study Chair: Yingfang Ao, Prof., Peking Yniversity Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT04955535
• Other Study ID Numbers: M201947901
• First Posted: Jul 8, 2021
• Last Update Posted: Jul 8, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Synovitis, Pigmented Villonodular; Synovitis

Study Results

No Results Posted as of Jul 8, 2021