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出境医 / 临床实验 / Integrative Analysis of Large-cell Lung Cancer (LCLC)
Integrative Analysis of Large-cell Lung Cancer (LCLC)
Study Description
Brief Summary:
Integrative analysis of LCLC
| Condition or disease | Intervention/treatment |
|---|---|
| Lung Cancer | Other: Normal lung tissue |
Detailed Description:
The investigators will analyzed proteomes of paired normal lung tissues and LCLC with or without liver metastasis, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal lung tissue, primary LCLC carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of lung cancer characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Retrospective |
| Official Title: | Integrative Analysis of Large-cell Lung Carcinoma |
| Study Start Date : | January 2016 |
| Estimated Primary Completion Date : | December 2026 |
| Estimated Study Completion Date : | December 2026 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Normal lung tissue
Normal lung tissue from LCLC patients
|
Other: Normal lung tissue
The investigators will extract total protein, DNA and RNA from LCLC patients.
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|
LCLC tissues
LCLC tissues from LCLC patients
|
Other: Normal lung tissue
The investigators will extract total protein, DNA and RNA from LCLC patients.
|
|
Metastasis tissues
Metastasis tissues from LCLC patients
|
Other: Normal lung tissue
The investigators will extract total protein, DNA and RNA from LCLC patients.
|
Outcome Measures
Primary Outcome Measures :
- 5 years overall survival [ Time Frame: 5 years ]
Secondary Outcome Measures :
- 5 years disease-free survival [ Time Frame: 5 years ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with large-cell lung cancer
Criteria
Inclusion Criteria:
- Age ≤ 75 years with histologically proven LCLC
- No severe major organ dysfunction
- World Health Organization (WHO) performance status of 0 or 1
- No prior cancer chemotherapy
Exclusion Criteria:
- Age ≥ 76
- Severe major organ dysfunction
- WHO performance status of >1
- Prior cancer chemotherapy
Contacts and Locations
Contacts
| Contact: Da Fu, PhD | 00-86-21-66301604 | fu800da900@126.com |
Locations
| China, Jiangxi | |
| Ganzhou City People's Hospital | Recruiting |
| Ganzhou, Jiangxi, China, 341000 | |
| Contact: Xiaoming Zhong, MD 00-86-797-8356156 15979192617@163.com | |
| Principal Investigator: Xiaoming Zhong, MD | |
| China, Shanghai | |
| Shanghai Tenth People's Hospital | Recruiting |
| Shanghai, Shanghai, China, 200072 | |
| Contact: Da Fu, PhD 00-86-21-66301604 fu800da900@126.com | |
| Principal Investigator: Yushui Ma, PhD | |
| Shanghai Pulmonary Hospital | Recruiting |
| Shanghai, Shanghai, China, 200433 | |
| Contact: Likun Hou, MD 00-86-21-65115006 ext 3030 hlk9575@163.com | |
| Principal Investigator: Likun Hou, MD | |
Sponsors and Collaborators
Shanghai 10th People's Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Investigators
| Principal Investigator: | Da Fu, PhD | Shanghai 10th People's Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | September 27, 2016 | ||||
| First Posted Date | September 28, 2016 | ||||
| Last Update Posted Date | September 28, 2016 | ||||
| Study Start Date | January 2016 | ||||
| Estimated Primary Completion Date | December 2026 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
5 years overall survival [ Time Frame: 5 years ] | ||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
5 years disease-free survival [ Time Frame: 5 years ] | ||||
| 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 | Integrative Analysis of Large-cell Lung Cancer | ||||
| Official Title | Integrative Analysis of Large-cell Lung Carcinoma | ||||
| Brief Summary | Integrative analysis of LCLC | ||||
| Detailed Description | The investigators will analyzed proteomes of paired normal lung tissues and LCLC with or without liver metastasis, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal lung tissue, primary LCLC carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of lung cancer characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients with large-cell lung cancer | ||||
| Condition | Lung Cancer | ||||
| Intervention | Other: Normal lung tissue
The investigators will extract total protein, DNA and RNA from LCLC patients.
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| Study Groups/Cohorts |
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| Publications * | Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4. | ||||
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* 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 |
1000 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 2026 | ||||
| Estimated Primary Completion Date | December 2026 (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 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT02917369 | ||||
| Other Study ID Numbers | 2016-52-Rainy | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
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| Responsible Party | Da Fu, Shanghai 10th People's Hospital | ||||
| Study Sponsor | Shanghai 10th People's Hospital | ||||
| Collaborators | Shanghai Pulmonary Hospital, Shanghai, China | ||||
| Investigators |
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| PRS Account | Shanghai 10th People's Hospital | ||||
| Verification Date | September 2016 | ||||
