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

November 9, 2018 updated by: First Hospital of Shijiazhuang City

A Prospective Multicenter Study of Longitudinal Monitoring in Treated Stage III-IV Lung Cancer Patients by Circulating Tumor DNA

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

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
    • Hebei
      • Baoding, Hebei, China, 071000
        • Recruiting
        • Affiliated Hospital of Hebei University
        • Contact:
          • Yanhong Shang
          • Phone Number: +86 13930811186
      • Shijiazhuang, Hebei, China, 050011
        • Recruiting
        • Hebei Medical University Fourth Hospital
        • Contact:
          • Wenbin Shen
      • Shijiazhuang, Hebei, China, 050011
        • Recruiting
        • The First Hospital of Shijiazhuang
        • Contact:
        • Contact:
      • Xingtai, Hebei, China, 054031
        • Recruiting
        • Xingtai People's Hospital
        • Contact:
          • Xiaozhen Wang
    • Heibe
      • Handan, Heibe, China, 056001
        • Recruiting
        • Handan Downtown Hospital
        • Contact:
          • Yuquan Ma
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
          • Jun Chen, M.D.
          • Phone Number: +86 15822192921
      • Tianjin, Tianjin, China, 300000
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
          • Dingzhi Huang, M.D.
          • Phone Number: +86 13116047308

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the accuracy of ctDNA
Time Frame: 1 year
To assess the accuracy of ctDNA when imaging undetectable or difficult to assess
1 year
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
1 year
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Hospital of Shijiazhuang City

Collaborators

Peking University People's Hospital
Tianjin Medical University Cancer Institute and Hospital
Affiliated Hospital of Hebei University
Tianjin Medical University General Hospital
Hebei Medical University Fourth Hospital
Xingtai People's Hospital

Investigators

  • Study Chair: Jun Wang, M.D., Peking University People's Hospital
  • Principal Investigator: Yan Zhang, M.D., The First Hospital of Shijiazhuang
  • Study Director: Kezhong Chen, M.D., Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2018

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

September 7, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 11, 2018

Study Record Updates

Last Update Posted (Actual)

November 13, 2018

Last Update Submitted That Met QC Criteria

November 9, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTH01801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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