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出境医 / 临床实验 / The Diagnosis and Mechanism of Pleural Effusion
The Diagnosis and Mechanism of Pleural Effusion
Study Description
Brief Summary:
The diagnosis, treatment and mechanism of pleural diseases
| Condition or disease | Intervention/treatment |
|---|---|
| Pleural Diseases | Other: Collection of pleural effusion |
Detailed Description:
The diagnosis and treatment of benign and malignant pleural effusions, the mechanisms of pleural diseases
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 1000 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | The Diagnosis and Mechanism of Pleural Effusion |
| Actual Study Start Date : | July 1, 2019 |
| Estimated Primary Completion Date : | February 1, 2020 |
| Estimated Study Completion Date : | August 1, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
experimental group
patients with malignant pleural effusion
|
Other: Collection of pleural effusion
Detection of pleural effusion
|
|
control group
patients with benign pleural effusion
|
Other: Collection of pleural effusion
Detection of pleural effusion
|
Outcome Measures
Primary Outcome Measures :
- overall survival [ Time Frame: 1 years ]the percentage of people in a group who are alive after a year for malignant pleural effusion
Biospecimen Retention: Samples With DNA
The blood and pleural effusions if there is any, will be collected and detected
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patients with pleural effusion
Criteria
Inclusion Criteria:
Patients with pleural effusion, who has not been treated
Exclusion Criteria:
Patients with pleural effusion, who has already been treated
Contacts and Locations
Locations
| China, State... | |
| Jinshuo Fan | |
| Wuhan, State..., China, 430022 | |
Sponsors and Collaborators
Wuhan Union Hospital, China
Investigators
| Study Director: | Jinshuo Fan, MD | Key Laboratory of Respiratory Diseases of the Ministry of Health |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | January 22, 2019 | ||||||
| First Posted Date | June 25, 2019 | ||||||
| Last Update Posted Date | August 29, 2019 | ||||||
| Actual Study Start Date | July 1, 2019 | ||||||
| Estimated Primary Completion Date | February 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
overall survival [ Time Frame: 1 years ] the percentage of people in a group who are alive after a year for malignant pleural effusion
|
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| Original Primary Outcome Measures |
overall survival [ Time Frame: 1 years ] | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures | Not Provided | ||||||
| Original Secondary Outcome Measures | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | The Diagnosis and Mechanism of Pleural Effusion | ||||||
| Official Title | The Diagnosis and Mechanism of Pleural Effusion | ||||||
| Brief Summary | The diagnosis, treatment and mechanism of pleural diseases | ||||||
| Detailed Description | The diagnosis and treatment of benign and malignant pleural effusions, the mechanisms of pleural diseases | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Retention: Samples With DNA Description:
The blood and pleural effusions if there is any, will be collected and detected
|
||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | patients with pleural effusion | ||||||
| Condition | Pleural Diseases | ||||||
| Intervention | Other: Collection of pleural effusion
Detection of pleural effusion
|
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| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Unknown status | ||||||
| Actual Enrollment |
1000 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | August 1, 2020 | ||||||
| Estimated Primary Completion Date | February 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria: Patients with pleural effusion, who has not been treated Exclusion Criteria: Patients with pleural effusion, who has already been treated |
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| Sex/Gender |
|
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| Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | China | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03997669 | ||||||
| Other Study ID Numbers | 001 | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Yang Jin, Wuhan Union Hospital, China | ||||||
| Study Sponsor | Wuhan Union Hospital, China | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
|
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| PRS Account | Wuhan Union Hospital, China | ||||||
| Verification Date | June 2019 | ||||||
