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NCT06056999Recruiting

New Method to Differentiate Benign and Malignant Pulmonary Nodules.

A New Method to Differentiate Benign and Malignant Pulmonary Nodules by Mass Spectrometry Combined With Artificial Intelligence.

Source: ClinicalTrials.gov · Last updated 18 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this observational clinical trial is to establish a new method for differentiating benign and malignant pulmonary nodules by peripheral blood detection in patients with pulmonary nodules (\<3cm). The main questions it aims to answer is: How to combine blood metabolomic mass spectrometry detection and artificial intelligence image analysis to establish a new model for differentiating benign and malignant pulmonary nodules. Participants will be asked provide 4 mL peripheral blood for the test.

Status (registry)
Recruiting
Study type
Observational
Enrollment
150 (estimated)
First submitted
21 Sept 2023
Start date
29 Sept 2023
Primary completion date
Jan 2025
Lead sponsor
China-Japan Friendship Hospital
Diseases
Lung cancer
NCT number
NCT06056999

What you commit to

  • Study type: Observational
  • Planned participants: 150
  • From 29 Sept 2023 to the primary completion date, Jan 2025
  • 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.

Prior treatment

  • Severe vascular lesions within the last 3 months, or known significant active infection, during acute/chronic tuberculosis infection, or severe cardiovascular and cerebrovascular diseases, dysfunction of liver and renal, or significant endocrine and metabolic disorders, or other serious concomitant diseases that are not controlled;

Other illness

  • History of malignant disease;
  • The specialist/surgeon assessed that puncture or surgery is not available, with contraindication such as coagulation disorders, cardiorespiratory insufficiency, etc.;
  • History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders, that may affect the signing of informed consent;
  • Other conditions deemed by the investigator to be unsuitable for enrollment.

Other

  • Imaging examination have suggested the possibility of metastasis at other sites;
  • ≥2 target lesions with different type categorized by density;
  • Pregnant or breastfeeding women;

Who the study is looking for

  • Age ≥18 years;
  • CT imaging shows the presence of pulmonary nodule \<3cm which is scheduled for puncture biopsy or surgery (i.e., the target lesion), the presence of ≥2 target lesions of the same type (categorized by density) are allowed;
  • Subjects are in good condition with Eastern Cooperative Oncology Group (ECOG) scale of 0-2;
  • Subjects with fair vital organ function, defined as: white blood cells ≥3.0×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥90g/L, alanine aminotransferase and aspartate aminotransferase ≤2.5 times the upper limit of normal values, and serum creatinine \<178μmol/L;
  • Subjects must have the ability to understand and sign the informed consent in writing voluntarily.

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
BeijingChinaRecruiting

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