NCT02422628

Brief Summary

Correlation of epithelial growth factor receptor mutation in blood of lung cancer patient and clinical outcome.

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
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

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

First Submitted

Initial submission to the registry

March 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 14, 2016

Status Verified

December 1, 2016

Enrollment Period

3.7 years

First QC Date

March 29, 2015

Last Update Submit

December 12, 2016

Conditions

Lung Cancer

Keywords

EGFR inhibitorEGFR mutationEGFRadenocarcinomaEGFR TKItreatmentNon small cell

Outcome Measures

Primary Outcomes (1)

  • Progressive disease measured by RECIST criteria after receiving 1st line EGFR-TKI

    3 years

Study Arms (3)

EGFR mutation postive

Blood samples every 3 months till disease progression or intolerable due to side effect.

EGFR mutation wild type

Blood samples before treatment once.

Healthy Volunteers

Blood samples once.

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with NSCLC adenocarcinoma

You may not qualify if:

  • Previous enrolment in the present study
  • As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
  • Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
  • Pregnancy or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples every 3 months till disease progression or intolerable due to side effect.

MeSH Terms

Conditions

Lung NeoplasmsAdenocarcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Chao-Chi Ho

    National Taiwan University Hospital No. 7, Chung-Shan South Road, Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2015

First Posted

April 21, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 14, 2016

Record last verified: 2016-12

Locations

TW(1)