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

  • China
    • 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
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.

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.

Sponsor

Shanghai 10th People's Hospital

Collaborators

Anhui Medical University
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

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.

General Publications

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.

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