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NCT06187935Completed

Early Adjuvant Diagnosis of Pulmonary Nodules Based on CTC.

Early Adjuvant Diagnosis Clinical Trial of Pulmonary Nodules Based on Circulating Tumor Cells.

Source: ClinicalTrials.gov · Last updated 27 Feb 2025

Brief summary (registry, in English)

The goal of this observational clinical trial is to evaluate the value of circulating tumor cell detection in the early diagnosis of malignant pulmonary nodule. The main questions it aims to answer is: the sensitivity and specificity of peripheral blood circulating tumor cell detection in differentiating benign and malignant pulmonary nodules (≤3cm). Participants will be asked provide 4mL of peripheral blood for the test.

Status (registry)
Completed
Study type
Observational
Enrollment
172 (actual)
First submitted
7 Dec 2023
Start date
1 Jan 2019
Primary completion date
31 Mar 2024
Lead sponsor
China-Japan Friendship Hospital
NCT number
NCT06187935

What you commit to

  • Study type: Observational
  • Participants enrolled: 172
  • From 1 Jan 2019 to the primary completion date, 31 Mar 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 1\. The subjects had a history of malignant tumors, or serious cardiovascular and cerebrovascular diseases (had undergone heart stent surgery within 6 months or had been admitted to ICU, CCU or other intensive care units due to cardiovascular and cerebrovascular diseases, or EF≤50%); b. Severe vasculopathy, pulmonary tuberculosis or large-scale acute inflammation (including but not limited to acute bronchitis, vasculitis, etc.) or active chronic infection (HIV, HBV, HCV, etc.) within 3 months; 3. Poor compliance, unable to cooperate with the research program; 4. Participants in any drug trial within three months prior to enrollment; 5. Pregnant or breastfeeding; 6. Puncture/Surgical contraindications.

Who the study is looking for

  • 1\. Patients with single or multiple pulmonary nodules on CT imaging; 2. Subjects ≥18 years old, regardless of gender, occupation, and region, should have independent capacity for civil conduct and sign the informed consent for clinical study; 3. Subjects are generally in good condition, with ECOG score 0-1 and life expectancy of no less than 2 months; 4. Organ function level requirements:
  • Peripheral blood: 1.5 x 10\^9/L≤ absolute neutrophil count (ANC) ≤15 x 10\^9/L, platelets ≥100 x 10\^9/L, hemoglobin ≥9.0 g/dL; Prothrombin time (PT) ≥11 seconds, International normalized ratio (INR) ≥0.8;
  • Bilirubin ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal;
  • Serum creatinine ≤1.5 times the upper limit of normal value.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
China-Japan Friendship Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.