NCT02299622

Brief Summary

The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information Therefore, a big data of genome-clinical information is important.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

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

Study Start

First participant enrolled

November 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

9 years

First QC Date

November 19, 2014

Last Update Submit

March 18, 2021

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • the spectrum of targetable genetic mutation in evaluated cancer specimens (for example, % of EGFR T790M mutation, BRAF mutation, or ALK mutation)

    The pattern of the tumor's molecular profiling in advanced thoracic (lung, esophagus, or tthymic) cancer

    3 years

Interventions

Genetic testGENETIC

Next-generation sequencing (AmpliSeq) \& fusion analysis

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

metastatic, histologically confirmed NSCLC, head \& Neck Cancer, Esophageal cancer

You may qualify if:

  • metastatic, histologically confirmed NSCLC, head \& Neck Cancer, Esophageal cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

fresh tissue

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Keunchil Park

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Keunchil Park

CONTACT

822-3410-3459kpark@skku.edu

Study Design

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

Study Record Dates

First Submitted

November 19, 2014

First Posted

November 24, 2014

Study Start

November 1, 2013

Primary Completion

November 1, 2022

Study Completion

December 1, 2023

Last Updated

March 19, 2021

Record last verified: 2021-03

Locations

KR(1)