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Integrative Analysis of Pulmonary Sarcomatoid Carcinoma (PSC) (PSC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04215913
Recruitment Status : Not yet recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Collaborators:
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Anhui Medical University
Information provided by (Responsible Party):
Da Fu, Shanghai 10th People's Hospital

Brief Summary:
Integrative Analysis of pulmonary sarcomatoid carcinoma (PSC)

Condition or disease Intervention/treatment
Lung Cancer Other: The investigators will extract total protein, DNA and RNA from PSC patients.

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 10 Years
Official Title: Integrative Analysis of Pulmonary Sarcomatoid Carcinoma (PSC)
Estimated Study Start Date : December 30, 2019
Estimated Primary Completion Date : December 24, 2025
Estimated Study Completion Date : December 24, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Normal lung tissue
Normal lung tissue from PSC patients
Other: The investigators will extract total protein, DNA and RNA from PSC patients.
The investigators will extract total protein, DNA and RNA from PSC patients.

PSC tissues
PSC tissues from PSC patients
Other: The investigators will extract total protein, DNA and RNA from PSC patients.
The investigators will extract total protein, DNA and RNA from PSC patients.

Metastasis tissues
Metastasis tissues from PSC patients
Other: The investigators will extract total protein, DNA and RNA from PSC patients.
The investigators will extract total protein, DNA and RNA from PSC patients.




Primary Outcome Measures :
  1. 10 years overall survival [ Time Frame: 10 years overall survival ]
    10 years overall survival


Secondary Outcome Measures :
  1. 10 years disease-free survival [ Time Frame: 10 years disease-free survival ]
    10 years disease-free survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with pulmonary sarcomatoid carcinoma
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04215913


Locations
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China, Shanghai
Da Fu
Shanghai, Shanghai, China, 200072
Sponsors and Collaborators
Shanghai 10th People's Hospital
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Anhui Medical University
Publications of Results:
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Responsible Party: Da Fu, Professor, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT04215913    
Other Study ID Numbers: 2019-FD52Rainy-PSC
FD52Rainy ( Registry Identifier: PSC )
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Da Fu, Shanghai 10th People's Hospital:
PSC
Integrative Analysis
IHC
WES
RNA sequencing
Additional relevant MeSH terms:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms