NCT04159337

Brief Summary

Companion diagnosis by large-panel is in increasing acceptance and need during clinical cancer management. The purpose of this trial is to investigate the benefit of large-panel NGS analysis in companion diagnosis of advanced lung cancer patients and further optimize the parameters.

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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Typical duration 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

Study Start

First participant enrolled

August 30, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

November 12, 2019

Status Verified

November 1, 2019

Enrollment Period

2.3 years

First QC Date

October 23, 2019

Last Update Submit

November 7, 2019

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (2)

  • Progression-free survival (PFS)

    PFS refers to the time from initial treatment to the time of disease progression or death

    through the whole study period, an average of 3 year

  • Tumor Mutational Burden (TMB)

    TMB is defined as the total number of detected somatic mutation counts in coding regions per million bases

    halfway of the study, an average of 1.5 year

Secondary Outcomes (3)

  • Other biomarkers

    halfway of the study, an average of 1.5 year

  • Clonality

    halfway of the study, an average of 1.5 year

  • Overall survival (OS)

    through the whole study period, an average of 3 year

Interventions

The method of gene mutation detectionOTHER

All samples were detected by large-panel, whereas some of which were also detected by WES.

Eligibility Criteria

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

patients in shanghai chest hospital

You may qualify if:

  • Participant aged 18 or above, and gender unrestricted
  • Individual with pathologically diagnosed lung cancer

You may not qualify if:

  • Patients with concomitant other tumors
  • Individual with severe cardiopulmonary insufficiency and hypoproteinemia
  • Women who were pregnant and were during their lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Niu Xiaomin

CONTACT

021-22200000-3403ar_tey@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

October 23, 2019

First Posted

November 12, 2019

Study Start

August 30, 2019

Primary Completion

January 1, 2022

Study Completion

May 31, 2022

Last Updated

November 12, 2019

Record last verified: 2019-11

Locations

CN(1)