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A Prognosis and Predicting Genetic Study of Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03234179
Recruitment Status : Not yet recruiting
First Posted : July 31, 2017
Last Update Posted : August 1, 2017
Information provided by (Responsible Party):
National Taiwan University Hospital

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).

Condition or disease
Lung Cancer Genetic Predisposition to Disease

Detailed Description:
To delineate the genetic etiology underlying NSCLC, this study proposes to employ a family-based linkage analysis, together with rich data generated from NGS, to search for disease susceptibility locus for the patients with strong family history of primary NSCLC. By using family pedigrees, linkage analysis will be able to find co-segregation of alleles through multiple generations at a genetic susceptibility locus and a known genetic marker, and then the highly penetrate gene loci may be detected by our study. These gene loci will be a good genetic predictor of NSCLC which should be a great advantage in treatment, prevention and screening of NSCLC in the future.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: A Prognosis and Predicting Genetic Study of Lung Cancer
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2037

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. Genetic information of lung cancer patients [ Time Frame: One week after the study subjects sign the permit of informed consents ]
    Collect study subjects' blood sample and analysis with Genome-wide SNP genotyping

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with diagnosis of primary non small cell lung cancer

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03234179

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Contact: Tung-Ming Tsai, MD +886972792011
Contact: Jin-Shing Chen, PhD +8869721451

Sponsors and Collaborators
National Taiwan University Hospital
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Study Director: Jin-Shing Chen, PhD National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital Identifier: NCT03234179     History of Changes
Other Study ID Numbers: 201705110RIND
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Non small cell lung cancer
Genetic study
Additional relevant MeSH terms:
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Genetic Predisposition to Disease
Lung Neoplasms
Disease Susceptibility
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes