Clinical trial · Observational
Prognostic and Dynamic Change of CTC Enumeration in Advanced NSCLC With Chemotherapy and Targeted Therapy
A Multicenter, Prospective, Observational Trial on the Prognostic and Dynamic Change of CTC Enumeration in Advanced NSCLC With 1st or 2nd Line Line Chemotherapy and Targeted Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
TITLE : A Multicenter, Prospective, Observational Trial on the Prognostic and Dynamic Change of CTC Enumeration in Advanced NSCLC with 1st or 2nd line chemotherapy and targeted therapy BACKGROUND : Circulating tumor cells (CTC) identification is a new field of research in oncology, and some studies have been conducted with success on breast and prostate cancer. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). CTC identification and monitoring these cells after treatment could help the clinicians to detect relapse or be a prognostic factor. PRIMARY OBJECTIVE : To study the relationship between CTC count and clinical outcome of treatment (Overall response rate and Progression-free survival). SECONDARY OBJECTIVES :To study the relationship between CTC and overall survival. STUDY DESIGN : This is a prospective, observational study. Duration of the inclusions: 12months. SAMPLE SIZE : 1200 patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Treatment
- description
- Treatment: Chemotherapy or targeted therapy
Primary outcomes (1)
- measure
- Baseline CTC count
- timeFrame
- Two year
Secondary outcomes (1)
- measure
- CTC count change
- timeFrame
- Two years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically documented, locally advanced or recurrent (stage IIIb and not amenable or combined modality treatment) or metastatic (stage IV) non-small cell lung cancer. * ECOG functional status≤2 * Chemotherapy:According to routine 1st line doublet chemotherapy in clinical practice, Cisplatin or carboplatin combined with gemcitabine or paclitaxel or docetaxol or Vinorelbine were recommended. According to routine 2nd line chemotherapy in clinical practice,pemetrexed or docetaxol * Targeted therapy：According to clinical criteria, patients with EGFR-TKI sensitive mutant accept first line TKI therapy. * Patients must have measurable disease according to the RECIST (version 1.1) criteria * Patients with a life expectancy greater than 12 weeks * Written (signed) informed Consent to participate in the study Exclusion Criteria: * Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer) * Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids. * Unwilling to write informed consent to participate in the study * Patients who is unwilling to accept the follow-up.
References
Publications (0)
Data not yet available