Early Adjuvant Diagnosis of Pulmonary Nodules Based on CTC.

NCT06187935 | Completed

• 1 other identifier: 2018-170-K124
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Nodules, Solitary; Pulmonary Nodules, Multiple

Outcome Measures

Primary Outcomes (2)

• sensitivity

  the ability of peripheral blood CTC count detection to identify malignant pulmonary nodules when the real condition is malignancy

  until the samples are collected and tested as planned, up to 72 months

• specificity

  the ability of peripheral blood CTC count detection to exclude malignant pulmonary nodules when the real condition is benign disease

  until the samples are collected and tested as planned, up to 72 months

Study Arms (1)

pulmonary nodule group

Patients with pulmonary nodules no more than 3cm on CT imaging.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pulmonary nodules no more than 3cm on CT imaging that are clinically suspected to be malignant and scheduled for surgery or biopsy.

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

circulating tumor cell

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Guangying Zhu, M.D.

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 3, 2024
• Study Start: January 1, 2019
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available starting 6 months and ending 5 years following article publication.
• Access Criteria: People who provide reasonable research protocols can get access to the data by contacting the researchers.

Locations

CN (1)