Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA

NCT02833467 | Unknown

• 1 other identifier: PTHO1502
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

Targeted next generation sequencing (NGS) provides a promising method for diagnostic purposes by enabling the simultaneous detection of multiple gene mutations. This study is to evaluate the feasibility and application value by using NGS into identifying genomic mutations in multiple or multifocal primary lung cancers in cell-tumor DNA (ctDNA) from surgical patients

Conditions

Carcinoma; Non-small-cell Lung Cancer; Thoracic Neoplasms

Keywords

Circulating Tumor DNA; Heterogeneous; Multiple primary lung cancer

Outcome Measures

Primary Outcomes (1)

• The detection rate of cancer related genes in multiple primary lung cancer patients by targeted next generation sequencing

  18 months

Secondary Outcomes (3)

• The concordant and discordant frequency of genomic results between tumor tissue and circulating tumor DNA in multiple primary lung cancer patients

  18 months

• The relationship between disease free survival and genomic results in multiple primary lung cancer patients

  5 years

• The relationship between overall survival and genomic results in multiple primary lung cancer patients

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple or multifocal primary lung cancer patients who underwent surgery

You may qualify if:

• Patients must have given written informed consent
• Histopathologically confirmed NSCLC
• Considered multiple or multifocal primary lung cancer by clinical criteria

You may not qualify if:

• Malignant tumor history within the past 5 years
• Patients who received any treatment prior to resection
• Insufficient tumor tissue or blood sample

Sponsors & Collaborators

• Peking University People's Hospital: lead
• San Valley Biotechnology Incorporated: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Fresh tumor tissue, peripheral blood cells, and plasma samples were collected from each patient.

MeSH Terms

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung; Thoracic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kezhong Chen, M.D.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Jun Wang, M.D.

  Peking University People's Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD，Thoracic Surgery Service

Study Record Dates

• First Submitted: July 9, 2016
• First Posted: July 14, 2016
• Study Start: January 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: June 1, 2021
• Last Updated: August 28, 2019

Record last verified: 2019-08