NCT03234179

Brief Summary

Lung cancer is a leading cause of cancer mortality among adults worldwide. The incidence rates of lung cancer among never smoking females in some parts of East Asia are among the highest in the world. The adenocarcinoma of lung being the most frequently identified histological type is more weakly associated with smoking, and often occurs in females and never-smokers. Although family history of lung cancer has been associated with histological subtypes, the inherited susceptibility factors that affect specific histology are unknown. Genetic factors that determine individual predisposition to lung cancer have been identified via genome-wide association studies. These known common loci, however, explain only a small fraction of the familial risk of lung cancer. The hypothesis of this study is that there are genetic factors that confer inherited susceptibility among patients with primary non-small-cell lung cancer (NSCLC).

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
137mo left

Started Aug 2017

Longer than P75 for all trials

Status
not yet recruiting

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 Progress44%
Aug 2017Aug 2037

First Submitted

Initial submission to the registry

July 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
17 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2037

Expected
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

3 years

First QC Date

July 26, 2017

Last Update Submit

July 30, 2017

Conditions

Keywords

Non small cell lung cancerGenetic study

Outcome Measures

Primary Outcomes (1)

  • Genetic information of lung cancer patients

    Collect study subjects' blood sample and analysis with Genome-wide SNP genotyping

    One week after the study subjects sign the permit of informed consents

Eligibility Criteria

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

Patients with diagnosis of primary non small cell lung cancer

You may qualify if:

  • The patient's family (within third-degree relatives) has at least one diagnosed of primary non-small cell lung cancer.
  • The patient was diagnosed of primary non-small cell lung cancer at the age \< 45 years old.

You may not qualify if:

  • Patients without the diagnosis of primary non-small cell lung cancer.
  • Patients who are combined with other malignancy and ongoing chemotherapy / radiation therapy.
  • Patients combined with coagulopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

The samples are stored at the lab of NTUH hospital with protected of security. The information of the study subjects will be reached only by investigator of this study.

MeSH Terms

Conditions

Lung NeoplasmsGenetic Predisposition to DiseaseCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Jin-Shing Chen, PhD

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

Tung-Ming Tsai, MD

CONTACT

Jin-Shing Chen, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 31, 2017

Study Start

August 1, 2017

Primary Completion

August 1, 2020

Study Completion (Estimated)

August 1, 2037

Last Updated

August 1, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

No plan to share IPD to other researchers.