Integrative Analysis of Pulmonary Sarcomatoid Carcinoma (PSC) (PSC)
December 29, 2019 updated by: Da Fu, Shanghai 10th People's Hospital
Integrative Analysis of pulmonary sarcomatoid carcinoma (PSC)
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The investigators will analyzed proteomes of paired normal lung tissues and pulmonary sarcomatoid carcinoma with or without metastasis, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal lung tissue, primary pulmonary sarcomatoid 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
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200072
- Da Fu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with pulmonary sarcomatoid carcinoma
Description
Inclusion Criteria:
- Age ≤ 70 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 ≥ 70
- Severe major organ dysfunction
- WHO performance status of >1
- Prior cancer chemotherapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Normal lung tissue
Normal lung tissue from PSC patients
|
The investigators will extract total protein, DNA and RNA from PSC patients.
|
|
PSC tissues
PSC tissues from PSC patients
|
The investigators will extract total protein, DNA and RNA from PSC patients.
|
|
Metastasis tissues
Metastasis tissues from PSC patients
|
The investigators will extract total protein, DNA and RNA from PSC patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
10 years overall survival
Time Frame: 10 years overall survival
|
10 years overall survival
|
10 years overall survival
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
10 years disease-free survival
Time Frame: 10 years disease-free survival
|
10 years disease-free survival
|
10 years disease-free survival
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
December 30, 2019
Primary Completion (ANTICIPATED)
December 24, 2025
Study Completion (ANTICIPATED)
December 24, 2025
Study Registration Dates
First Submitted
December 29, 2019
First Submitted That Met QC Criteria
December 29, 2019
First Posted (ACTUAL)
January 2, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 2, 2020
Last Update Submitted That Met QC Criteria
December 29, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-FD52Rainy-PSC
- FD52Rainy (REGISTRY: PSC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
There is no plan to make individual participant data (IPD) available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.