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

NCT ID: NCT03664843

Last Updated: 2018-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-09

Study Completion Date

2020-09-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Carcinoma Non-small Cell Lung Cancer Lung Neoplasm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role collaborator

Affiliated Hospital of Hebei University

OTHER

Sponsor Role collaborator

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role collaborator

Xingtai People's Hospital

OTHER

Sponsor Role collaborator

First Hospital of Shijiazhuang City

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Shijiazhuang

Jun Wang, M.D.

Role: STUDY_CHAIR

Peking University People's Hospital

Kezhong Chen, M.D.

Role: STUDY_DIRECTOR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Affiliated Hospital of Hebei University

Baoding, Hebei, China

Site Status RECRUITING

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, China

Site Status RECRUITING

The First Hospital of Shijiazhuang

Shijiazhuang, Hebei, China

Site Status RECRUITING

Xingtai People's Hospital

Xingtai, Hebei, China

Site Status RECRUITING

Handan Downtown Hospital

Handan, Heibe, China

Site Status RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yan Zhang, M.D.

Role: CONTACT

17603119607 ext. +86

Kezhong Chen, M.D.

Role: CONTACT

13488752289 ext. +86

Facility Contacts

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Kezhong Chen, M.D.

Role: primary

13488752289 ext. +86

Yanhong Shang

Role: primary

13930811186 ext. +86

Wenbin Shen

Role: primary

Yan Zhang, M.D.

Role: primary

17603119607 ext. +86

Zhenlin Gao

Role: backup

18803216093 ext. +86

Xiaozhen Wang

Role: primary

Yuquan Ma

Role: primary

Dingzhi Huang, M.D.

Role: primary

13116047308 ext. +86

Jun Chen, M.D.

Role: primary

15822192921 ext. +86

Other Identifiers

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PTH01801

Identifier Type: -

Identifier Source: org_study_id

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