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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03664843
• Other study ID #: PTH01801
• Status: Recruiting
• Start date: November 9, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: November 2018
• Source: First Hospital of Shijiazhuang City
• Contact: Yan Zhang, M.D.
• Phone: 17603119607
• Email: 13315978836[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasm
• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding	Hebei
China	Peking University People's Hospital	Beijing	Beijing
China	Handan Downtown Hospital	Handan	Heibe
China	Hebei Medical University Fourth Hospital	Shijiazhuang	Hebei
China	The First Hospital of Shijiazhuang	Shijiazhuang	Hebei
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Xingtai People's Hospital	Xingtai	Hebei

Sponsors (7)

Lead Sponsor	Collaborator
First Hospital of Shijiazhuang City	Affiliated Hospital of Hebei University, Hebei Medical University Fourth Hospital, Peking University People's Hospital, Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University General Hospital, Xingtai People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ctDNA effective time	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
Primary	ctDNA leading time	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	Assess the accuracy of ctDNA	To assess the accuracy of ctDNA when imaging undetectable or difficult to assess	1 year
Secondary	Compared to conventional image	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
Secondary	Compared to traditional tumor markers	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