Condition or disease |
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Carcinoma, Non-Small-Cell Lung |
Study Type : | Observational |
Estimated Enrollment : | 700 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Real-World Molecular Testing, Treatment Patterns and Clinical Outcomes in Chinese Patients With Stage III NSCLC- A Prospective, Non-Interventional Study(MOOREA) |
Actual Study Start Date : | July 16, 2019 |
Estimated Primary Completion Date : | May 30, 2022 |
Estimated Study Completion Date : | May 30, 2022 |
Group/Cohort |
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Cohort 1
Cohort 1, including patients without surgical resection, will be defined as unresectable stage III NSCLC
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Cohort 2
Cohort 2,including patients with surgical resection, will be defined as resectable stage III NSCLC
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Molecular testing patterns including:
Molecular testing rate defined as the number of patients who received molecular testing divided by total patient's number; Molecular testing details including sample type, test type; Molecular testing results.
Ages Eligible for Study: | 18 Years to 130 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Enrolment in studies that prohibit any participation in this observational study.
Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
China, Beijing | |
Research Site | Not yet recruiting |
Beijing, Beijing, China | |
Research Site | Recruiting |
Beijing, Beijing, China | |
Research Site | Withdrawn |
Shenzhen, Beijing, China | |
China, Guangdong | |
Research Site | Recruiting |
Guangzhou, Guangdong, China | |
Research Site | Recruiting |
Shantou, Guangdong, China | |
China, Guangxi | |
Research Site | Recruiting |
Nanning, Guangxi, China | |
China, Hebei | |
Research Site | Recruiting |
Baoding, Hebei, China | |
Research Site | Recruiting |
Shijiazhuang, Hebei, China | |
Research Site | Not yet recruiting |
Shijiazhuang, Hebei, China | |
China, Heilongjian | |
Research Site | Not yet recruiting |
Qiqihar, Heilongjian, China | |
China, Hongkong | |
Research Site | Recruiting |
Hongkong, Hongkong, China | |
China, Hubei | |
Research Site | Recruiting |
Wuhan, Hubei, China | |
China, Jiangsu | |
Research Site | Recruiting |
Suzhou, Jiangsu, China | |
China, Jiangxi | |
Research Site | Recruiting |
Nanchang, Jiangxi, China | |
China, Jilin | |
Research Site | Recruiting |
Changchun, Jilin, China | |
China, Liaoning | |
Research Site | Not yet recruiting |
Dalian, Liaoning, China | |
China, Ningxia | |
Research Site | Recruiting |
Yinchuan, Ningxia, China | |
China, Shandong | |
Research Site | Recruiting |
Jinan, Shandong, China | |
Research Site | Recruiting |
Qingdao, Shandong, China | |
China, Shanghai | |
Research Site | Recruiting |
Shanghai, Shanghai, China | |
Research Site | Not yet recruiting |
Shanghai, Shanghai, China | |
Research Site | Withdrawn |
Shanghai, Shanghai, China | |
China, Shanxi | |
Research Site | Recruiting |
Taiyuan, Shanxi, China | |
China, Sichuan | |
Research Site | Recruiting |
Chengdu, Sichuan, China | |
China, Tianjin | |
Research Site | Not yet recruiting |
Tianjin, Tianjin, China | |
China, Zhejiang | |
Research Site | Recruiting |
Taizhou, Zhejiang, China |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date | May 30, 2019 | ||||
First Posted Date | July 18, 2019 | ||||
Last Update Posted Date | April 28, 2021 | ||||
Actual Study Start Date | July 16, 2019 | ||||
Estimated Primary Completion Date | May 30, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
To observe treatment patterns of unresectable, stage III NSCLC [ Time Frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months ] Treatment received before disease progress including chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy and radiotherapy
|
||||
Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
|
||||
Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Stage III NSCLC RWE in Chinese Patients | ||||
Official Title | Real-World Molecular Testing, Treatment Patterns and Clinical Outcomes in Chinese Patients With Stage III NSCLC- A Prospective, Non-Interventional Study(MOOREA) | ||||
Brief Summary | The objectives of this study are to assess molecular testing, treatment patterns and associated clinical outcomes in Chinese patients with treatment-naïve stage III non-small cell lung cancer (NSCLC) in real world setting. This study is a prospective, non-interventional study. It is descriptive in nature and does not attempt to test any specific a priori hypotheses | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Stage III NSCLC patients who received no prior systemic therapy for NSCLC before study enrolment | ||||
Condition | Carcinoma, Non-Small-Cell Lung | ||||
Intervention | Not Provided | ||||
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 | Recruiting | ||||
Estimated Enrollment |
700 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | May 30, 2022 | ||||
Estimated Primary Completion Date | May 30, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
|
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Ages | 18 Years to 130 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
|
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Listed Location Countries | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04023812 | ||||
Other Study ID Numbers | D4194R00009 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | AstraZeneca | ||||
Study Sponsor | AstraZeneca | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | AstraZeneca | ||||
Verification Date | April 2021 |