| Condition or disease |
|---|
| 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 |
|---|
|
Cohort 1
Cohort 1, including patients without surgical resection, will be defined as unresectable stage III NSCLC
|
|
Cohort 2
Cohort 2,including patients with surgical resection, will be defined as resectable stage III NSCLC
|
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| Research Site | Withdrawn |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 |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| 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:
|
||||
| Sex/Gender |
|
||||
| Ages | 18 Years to 130 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
|
||||
| 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 |
|
||||
| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | AstraZeneca | ||||
| Study Sponsor | AstraZeneca | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | AstraZeneca | ||||
| Verification Date | April 2021 | ||||