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ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage I NSCLS by NGS

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ClinicalTrials.gov Identifier: NCT03172156
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : October 11, 2017
Sponsor:
Collaborator:
First Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Si-Yu Wang, Sun Yat-sen University

Brief Summary:
CtDNA detection is a noninvasive detection method, and the second generation of high-throughput gene sequencing (NGS) is an important means of detecting ctDNA, which can detect trace ctDNA from smaller plasma samples. This project is to study the role of ctDNA dynamic monitoring of stage I NSCLC by NGS technique to verify the prognostic predictive effect of ctDNA .

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Stage I Genetic: ctDNA detection

Detailed Description:
CtDNA detection as a noninvasive detection method, can truly reflect the real tumor tissue gene mutation map and frequency, is the evaluation of therapeutic effect and the important monitoring indicators of clinical follow-up after treatment. The second generation of high-throughput gene sequencing (NGS) is an important means of detecting ctDNA, which can detect trace ctDNA from smaller plasma samples. The ctDNA dynamic monitoring of stage I non-small cell lung cancer (NSCLC) was performed by the second generation gene sequencing (NGS) technique to verify the prognostic predictive effect of ctDNA in stage I NSCLC patients without radiotherapy and targeted therapy.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicentre, Prospective, Open Clinical Study of Postoperative ctDNA Dynamic Monitoring and Its Role of Prognosis in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Stage I NSCLC patients after surgery with ctDNA detection
Stage I NSCLC patients;ctDNA detection
Genetic: ctDNA detection
To detect ctDNA in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)




Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 2 years after the last patient enrolled ]
    Disease-free survival was assessed from surgery to disease recurrence or death as a result of any cause


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years after the last patient enrolled ]
    Overall survival was assessed from surgery to death as a result of any cause


Biospecimen Retention:   Samples With DNA
ctDNA of stage I non-small cell lung cancer (NSCLC)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients With Stage I Non-small Cell Lung Cancer (NSCLC) without Postoperative radiotherapy and chemotherapy
Criteria

Inclusion Criteria:

  • Postoperative histopathological diagnosis of TNM stage IA / IB NSCLC with R0 resection;
  • No adjuvant chemotherapy, radiotherapy, targeted drug therapy or biotherapy after surgery;

General selection criteria:

  • Men or women of age ≥18 years and <75 years old;
  • ECOG behavior status score 0 to 1;

Exclusion Criteria:

  • Patients with other cancers other than NSCLC within five years prior to this study;
  • who can not get enough tumor histological specimens (non-cytological) for analysis;
  • human immunodeficiency virus (HIV) infection;
  • NSCLC mixed with patients with small cell lung cancer;
  • pregnant or lactating women;
  • There is a clear history of neurological or mental disorders, including epilepsy or dementia;
  • Conditions that investigators think is not suitable for inclusion.

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 ClinicalTrials.gov identifier (NCT number): NCT03172156


Contacts
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Contact: Si-Yu Wang, MD 86-20-87343439 wsysums@163.net
Contact: zhenguo liu, MD 86-20-87755766 ext 8782 liuzg1340@126.com

Locations
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China, Guangdong
Si-Yu Wang Recruiting
Guangzhou, Guangdong, China, 510060
Contact: chao cheng, MD    +86-20-87755766 ext 8782    drchengchao@163.com   
Contact: Zhenguo Liu, MD    +86-20-87755766 ext 8782    liuzg1340@126.com   
Principal Investigator: Si-Yu Wang, MD         
Principal Investigator: Chao Cheng, MD         
Sub-Investigator: Zhenguo Liu, MD         
Sponsors and Collaborators
Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University

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Responsible Party: Si-Yu Wang, professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03172156     History of Changes
Other Study ID Numbers: GASTO1018
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators will not share IPD to other researchers until initial experimental conclusions is reached.

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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 Si-Yu Wang, Sun Yat-sen University:
NSCLC
stage I
The next generation of high-throughput gene sequencing (NGS)
ctDNA

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms