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

• Conditions: Non-small Cell Lung Cancer; Carcinoma; Lung Neoplasm

• Registration Number: NCT03664843
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-11
• Status Verified: 2018-11
• Study Start: 2018-11-09
• Last Update Submitted: 2018-11-09
• Last Update Posted: 2018-11-13
• Primary Completion: 2020-05-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ctDNA leading time	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.
ctDNA effective time	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.

Secondary Outcome Measures

Name	Time	Method
Compared to conventional image	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
Compared to traditional tumor markers	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
Assess the accuracy of ctDNA	1 year	To assess the accuracy of ctDNA when imaging undetectable or difficult to assess

Trial Locations

Locations (8)

Handan Downtown Hospital; 🇨🇳 Handan, Heibe, China

Hebei Medical University Fourth Hospital; 🇨🇳 Shijiazhuang, Hebei, China

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China

Affiliated Hospital of Hebei University; 🇨🇳 Baoding, Hebei, China

The First Hospital of Shijiazhuang; 🇨🇳 Shijiazhuang, Hebei, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China

Xingtai People's Hospital; 🇨🇳 Xingtai, Hebei, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China