NCT04215913

Brief Summary

Integrative Analysis of pulmonary sarcomatoid carcinoma (PSC)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

December 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2025

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

6 years

First QC Date

December 29, 2019

Last Update Submit

December 29, 2019

Conditions

Lung Cancer

Keywords

PSCIntegrative AnalysisIHCWESRNA sequencing

Outcome Measures

Primary Outcomes (1)

  • 10 years overall survival

    10 years overall survival

    10 years overall survival

Secondary Outcomes (1)

  • 10 years disease-free survival

    10 years disease-free survival

Study Arms (3)

Normal lung tissue

Normal lung tissue from PSC patients

Other: 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.

Metastasis tissues

Metastasis tissues from PSC patients

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

Interventions

The investigators will extract total protein, DNA and RNA from PSC patients.OTHER

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

Metastasis tissuesNormal lung tissuePSC tissues

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with pulmonary sarcomatoid carcinoma

You may qualify if:

  • 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

You may not qualify if:

  • Age ≥ 70
  • Severe major organ dysfunction
  • WHO performance status of \>1
  • Prior cancer chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Da Fu

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (1)

  • Boland JM, Mansfield AS, Roden AC. Pulmonary sarcomatoid carcinoma-a new hope. Ann Oncol. 2017 Jul 1;28(7):1417-1418. doi: 10.1093/annonc/mdx276. No abstract available.

    PMID: 28637281RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

DNA

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Nucleic AcidsNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 29, 2019

First Posted

January 2, 2020

Study Start

December 30, 2019

Primary Completion

December 24, 2025

Study Completion

December 24, 2025

Last Updated

January 2, 2020

Record last verified: 2019-12

Locations

CN(1)