Pigmented Villonodular SynovitisNCT04955535
Screening of Specific Genes for Pigmented Villous Nodular Synovitis
An observational study of Pigmented Villonodular Synovitis, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pigmented Villonodular Synovitis
- What is being tested?
- Arthroscopic synovectomy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2020to 27 Dec 2020
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with "pigmented villonodular synovitis" and "giant cell tumor of tendon sheath"
Who may be able to join
- Clinical diagnosis of pigmented villonodular synovitis.
- Clinical diagnosis of giant cell tumor of tendon sheath
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China
Beijing, Beijing Municipality, 100191
About this study
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.
Read the 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.
- Conditions
- Pigmented Villonodular Synovitis
- Being tested
- Arthroscopic synovectomy
- Medical subject headings
- Synovitis, Pigmented Villonodular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic synovectomyProcedure or surgery
Arthroscopic synovectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of scale score between immunohistochemistry positive group and negative group
Difference of Visual Analog Score for pain between CSF-1 immunohistochemistry positive group and negative group
Measured: One week after surgery
Difference of Visual Analog Score for pain between TNF-α immunohistochemistry positive group and negative group
Difference of Visual Analog Score for pain between TNF-α immunohistochemistry positive group and negative group
Measured: One week after surgery
Difference of Visual Analog Score for pain between IL-1B immunohistochemistry positive group and negative group
Difference of Visual Analog Score for pain between IL-1B immunohistochemistry positive group and negative group
Measured: One week after surgery
Difference of SF-36 score between CSF-1 immunohistochemistry positive group and negative group
Difference of SF-36 score between CSF-1 immunohistochemistry positive group and negative group
Measured: One week after surgery
Difference of SF-36 score between TNF-α immunohistochemistry positive group and negative group
Difference of SF-36 score between TNF-α immunohistochemistry positive group and negative group
Measured: One week after surgery
Difference of SF-36 score between IL-1B immunohistochemistry positive group and negative group
Difference of SF-36 score between IL-1B immunohistochemistry positive group and negative group
Measured: One week after surgery
Secondary outcomes (1)
Correlation between basic demographic characteristics and scale scores
Correlation between age, gender and scale score
Measured: One week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start3 Aug 2020
- Primary completion27 Dec 2020
- Study completion27 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigmented Villonodular SynovitisStudies of the same condition, open and under way.
- More trials run by Peking University Third 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 only
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingfang Ao, Prof., Study chair, Peking Yniversity Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955535
- Sponsor's protocol ID
- M201947901
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Specific Genes for Pigmented Villous Nodular Synovitis
- ClinicalTrials.gov ID
- NCT04955535
- Acronym / sponsor ID
- M201947901
- Conditions
- Pigmented Villonodular Synovitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 27 Dec 2020 (actual)
- Study completion
- 27 Dec 2020 (actual)
- First posted
- 8 Jul 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.
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.
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with "pigmented villonodular synovitis" and "giant cell tumor of tendon sheath"
Key inclusion criteria (2 listed)
- Clinical diagnosis of pigmented villonodular synovitis.
- Clinical diagnosis of giant cell tumor of tendon sheath
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Arthroscopic synovectomyArthroscopic synovectomy | Procedure or surgery | – |
Primary outcome
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
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
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
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
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
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
1 secondary outcome
Correlation between basic demographic characteristics and scale scores
Time frame: One week after surgery
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 8 Jul 2021.
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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.
Yingfang Ao, Prof. study chair
Peking Yniversity Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pigmented Villonodular Synovitis, run by Peking University Third Hospital at 1 site in China.
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 4 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 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Difference of scale score between immunohistochemistry positive group and negative group (time frame: One week after surgery). The study lists 6 primary outcomes in all. 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 8 Jul 2021.