Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Circulating Tumor DNA Longitudinal Monitoring in Stage III-IV Lung Cancer Patients

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.
ClinicalTrials.gov Identifier: NCT03664843
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : November 12, 2018
Sponsor:
Collaborators:
Peking University People's Hospital
Tianjin Medical University General Hospital
Tianjin Medical University Cancer Institute and Hospital
Affiliated Hospital of Hebei University
Hebei Medical University Fourth Hospital
Xingtai People's Hospital
Information provided by (Responsible Party):
First Hospital of Shijiazhuang City

Brief Summary:
Conduct a prospective study in multicenter to confirm the value of circulating tumor DNA in longitudinal monitoring of stage III-IV lung cancer patients.

Condition or disease
Carcinoma Non-small Cell Lung Cancer Lung Neoplasm

Detailed Description:
The study consists of two phases, the first stage is the exploratory stage of blood collection point which is the appropriate effective time after chemotherapy, radiotherapy, targeted therapy. The second phase, which is the expansion of the first phase, is to determine the precise leading time of ctDNA relative to tumor biomarkers or image evaluation in determining the efficacy of advanced NSCLC cancer therapy. Both stages were divided into three subgroups: the chemotherapy group, the radiotherapy group, and the targeted therapy group.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Multicenter Study of Longitudinal Monitoring in Treated Stage III-IV Lung Cancer Patients by Circulating Tumor DNA
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort
The chemotherapy cohort
Blood samples for ctDNA and biomarkers analysis are collected at before chemotherapy and at a series of scheduled time-points after chemotherapy , with serial two-weekly blood samples collected from a subset of patients. Meanwhile, imaging technology such as CT scan detection would be performed.
The radiotherapy cohort
Blood samples for ctDNA and biomarkers analysis are collected at before radiotherapy and at a series of scheduled time-points after radiotherapy, with serial two-weekly blood samples collected from a subset of patients. Meanwhile, imaging technology such as CT scan detection would be performed.
The targeted therapy cohort
Blood samples for ctDNA and biomarkers analysis are collected at before targeted therapy and at a series of scheduled time-points after targeted therapy, with serial two-weekly blood samples collected from a subset of patients. Meanwhile, imaging technology such as CT scan detection would be performed.



Primary Outcome Measures :
  1. ctDNA effective time [ Time Frame: 6 months ]
    To explore the appropriate chemo/ radio/ target effective time (CET/RET/TET) through measurement and monitoring of ctDNA after anti-cancer therapies in advanced NSCLC.

  2. ctDNA leading time [ Time Frame: 1 year ]
    To investigate the precise leading time for ctDNA compared to conventional biomarker or image evaluation in detecting disease recurrence after radiotherapy, chemotherapy, or targeted therapy respectively.


Secondary Outcome Measures :
  1. Assess the accuracy of ctDNA [ Time Frame: 1 year ]
    To assess the accuracy of ctDNA when imaging undetectable or difficult to assess

  2. Compared to conventional image [ Time Frame: 1 year ]
    Compared to conventional image evaluation, to determine the consistency of ctDNA in treatment response of measurable lesion after radiotherapy, chemotherapy, or targeted therapy respectively

  3. Compared to traditional tumor markers [ Time Frame: 6 months ]
    To explore the consistency for ctDNA in determining the efficacy of advanced NSCLC compared to tumor markers after radiotherapy, chemotherapy, or targeted therapy respectively


Biospecimen Retention:   Samples With DNA
Fresh tumor tissue and blood samples were collected from each patient. Histological specimens (fresh or paraffin blocks) of all enrolled patients before treatment need to be obtained, and according to different adjuvant therapy, blood samples were collected at a series of specific scheduled time-points


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population will be drawn from Oncology Department of multicenters. The enrolled patients must be patients with stage III-IV NSCLC according to the 8th edition of the TNM Classification of the International Association for the Study of Lung Cancer (IASLC), must be greater than 18 years old and must have the tissue specimens (fresh or wax blocks) before this treatment. The exclusion criteria are as followed: (1) Multiple primary lung cancer;(2) Incorporating any unstable systemic disease; (3) Histology is not NSCLC; (4)Unqualified blood samples; (5) Patients lacking any one of the detection points. All of the patients signing informed consent were not involved in the recruitment and conduct of the study
Criteria

Inclusion Criteria:

  1. Greater than 18 years old;
  2. Patients with stage III-IV NSCLC;
  3. Have the tissue specimens (fresh or wax blocks) before this treatment;
  4. PS<=2 in radiotherapy/ chemotherapy group; PS<=3 in targeted therapy group
  5. Signing informed consent;

Exclusion Criteria:

  1. Multiple primary lung cancer;
  2. Incorporating any unstable systemic disease;
  3. Histology is not NSCLC;
  4. Unqualified blood samples;
  5. Patients lacking any one of the detection points.

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): NCT03664843


Contacts
Layout table for location contacts
Contact: Yan Zhang, M.D. 17603119607 ext +86 13315978836@163.com
Contact: Kezhong Chen, M.D. 13488752289 ext +86 mdkzchen@163.com

Locations
Layout table for location information
China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Kezhong Chen, M.D.    13488752289 ext +86    mdkzchen@163.com   
China, Hebei
Affiliated Hospital of Hebei University Recruiting
Baoding, Hebei, China, 071000
Contact: Yanhong Shang    13930811186 ext +86      
Hebei Medical University Fourth Hospital Recruiting
Shijiazhuang, Hebei, China, 050011
Contact: Wenbin Shen         
The First Hospital of Shijiazhuang Recruiting
Shijiazhuang, Hebei, China, 050011
Contact: Yan Zhang, M.D.    17603119607 ext +86    13315978836@163.com   
Contact: Zhenlin Gao    18803216093 ext +86    gaozhenlin87@126.com   
Xingtai People's Hospital Recruiting
Xingtai, Hebei, China, 054031
Contact: Xiaozhen Wang         
China, Heibe
Handan Downtown Hospital Recruiting
Handan, Heibe, China, 056001
Contact: Yuquan Ma         
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300000
Contact: Dingzhi Huang, M.D.    13116047308 ext +86      
Tianjin Medical University General Hospital Recruiting
Tianjin, Tianjin, China, 300052
Contact: Jun Chen, M.D.    15822192921 ext +86      
Sponsors and Collaborators
First Hospital of Shijiazhuang City
Peking University People's Hospital
Tianjin Medical University General Hospital
Tianjin Medical University Cancer Institute and Hospital
Affiliated Hospital of Hebei University
Hebei Medical University Fourth Hospital
Xingtai People's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yan Zhang, M.D. The First Hospital of Shijiazhuang
Study Chair: Jun Wang, M.D. Peking University People's Hospital
Study Director: Kezhong Chen, M.D. Peking University People's Hospital

Layout table for additonal information
Responsible Party: First Hospital of Shijiazhuang City
ClinicalTrials.gov Identifier: NCT03664843     History of Changes
Other Study ID Numbers: PTH01801
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by First Hospital of Shijiazhuang City:
circulating tumor DNA
lung cancer
surveillance
longitudinal monitoring
lead time

Additional relevant MeSH terms:
Layout table for MeSH terms
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