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Phase I standardized clinical application of circulating tumor cells in the diagnosis, treatment and prognosis of lung cancer

Standardized application research of circulating tumor cells in the diagnosis and treatment of lung cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800017933
Enrollment
Unknown
Registered
2018-08-22
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Interventions

Case series:Nil

Sponsors

Huadong Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Diagnosis of patients with non-small cell lung cancer; (2) Patients with clinical TNM stage III-IV; (3) Age is 18 years old (including 18 years old) to 75 years old (including 75 years old); (4) Eastern Cooperative Oncology Group (ECOG) score 0-2 (see ECOGO scores in Annex I); (5) The main organs function well and the coagulation function is normal; (6) Life expectancy = 3 months; (7) Subjects signed an informed consent form prior to enrollment and agreed to participate in the study and follow the research procedure.

Exclusion criteria

Exclusion criteria: (1) Postoperative pathological non-lung adenocarcinoma patients; (2) Uncontrolled puncture site infection or systemic infection; (3) uncontrollable systemic bleeding disorders, severe hypercoagulable state, severe coagulopathy or subjects are using drugs that affect coagulation; (4) Those with a history of deep vein thrombosis or a history of pulmonary embolism; (5) Severe comorbidities, such as grade III, grade IV (New York Heart Association NYHA standard), myocardial infarction within 6 months or grade 3 or higher (including grade 3) angina pectoris, brain trauma, brain parasitism Patients with worm disease, progressive stroke, hepatic encephalopathy, autoimmune hepatitis, decompensated cirrhosis, liver dysfunction, renal insufficiency; (6) A history of allergic reactions to antibody drugs, or allergic patients, or those who are allergic to the test needle; (7) Human immunodeficiency virus (HIV)-positive patients, immunodeficiency diseases, combined immunodeficiency diseases, organ transplants, and patients with autoimmune diseases requiring immunosuppressive or steroidal therapy; (8) Previous history of other malignant tumors, except for cured skin basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ; (9) pregnant or lactating women; (10) According to the judgment of the investigator, there are serious accompanying diseases (including but not limited to hypertension, severe diabetes, active infection, thyroid disease, etc.) that seriously endanger the safety of the patient or affect the patient's completion of the study; (11) Any mental or cognitive impairment, emotionally unstable, may limit its understanding of the informed consent, implementation, and compliance with the study; (12) The investigator believes that it is not suitable for other situations in this trial.

Design outcomes

Primary

MeasureTime frame
Circulating tumor cells;

Countries

China

Contacts

Public ContactGao Wen

Huadong Hospital affiliated to Fudan University

gaowenchest@vip.163.com+86 13601745921

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026