Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06458673

A Prospective, Non-interventional Cohort Study of Subsolid Pulmonary Nodules

Some studies have shown that the model for judging and predicting the growth of sub-solid pulmonary nodules through big data and deep learning can detect nodule growth earlier. Since most of the training data come from large foreign samples, most of the validated data are CT data from a single center or a few centers, and their generalization ability needs to be further verified. In order to better study subsolid pulmonary nodules in the lungs in China, we plan to conduct a prospective, multicenter, non-interventional observational cohort study.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Solitary Lung Nodule Lung Diseases Lung Neoplasms Multiple Pulmonary Nodules Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Solitary Pulmonary Nodule Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Through the follow-up of pulmonary nodules, artificial intelligence based on CT was used to study the natural evolution process of subsolid pulmonary nodules, as well as the development law and prognosis of pulmonary subsolid nodules under treatment or no treatment according to clinical guidelines.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age≥ 18 years old, gender is not limited
  • Confirmed subsolid pulmonary nodule by CT, initial pulmonary nodule ≥ 5 mm (including subsolid components) and ≤ 30 mm, do not shrink or disappear after 3 months Follow-up.
  • ECOG 0～2
  • Able to provide CT in DICOM format
  • Informed consent obtained

Exclusion criteria

  • Long-term use of immunosuppressants and hormone drugs
  • History of previous malignancy (if there is no recurrence or carcinoma in situ for more than 5 years after receiving curative therapy, it can be enrolled)
  • Inability to cooperate with regular follow-up
  • Poor general condition, with the life expectancy less than 6 months

Treatment and study plan

Primary outcomes

  1. 5-year growth rate of subsolid pulmonary nodules

    Time frame: Regular follow-up was carried out according to clinical guidelines and local hospital guidelines, with an interval of 3-6 months and a duration of 5 years

    The 5-year growth rate of the nodules is calculated by comparing the initial and final diameters of the nodules during the follow-up period.Results are expressed as percentages.

Secondary outcomes

  1. Median time from enrollment to invasive diagnosis/intervention in patients with subsolid pulmonary nodules

    Time frame: The time from patient enrollment and initiation of follow-up until invasive diagnosis/intervention

    Median length of time from patient enrollment to invasive diagnosis or therapeutic intervention such as surgical excision, biopsy, or other therapeutic procedures

  2. Lung cancer-specific 5-year survival rate

    Time frame: From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up

    Lung cancer-specific 5-year survival rate is defined as a proportion of patients diagnosed with lung cancer who survive within 5 years of diagnosis

  3. explore the growth rate and pattern of radiographic changes of different types of pulmonary nodules

    Time frame: From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up

    the growth rate is calculated by comparing the initial and final diameters of the nodules during the follow-up period. Results are expressed as 1mm/year

  4. Sensitivity and specificity of radiomics in predicting the growth of subsolid pulmonary nodules

    Time frame: From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up

    the sensitivity and specificity is calculated by comparing the predicted results and the real results

Study contacts

Contact information is provided by the study sponsor or research team.

Xuening Yang, MD

CONTACT

[email protected]

0086-13922713300

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Collaborators

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
  • Fifth Affiliated Hospital, Sun Yat-Sen University
  • First Affiliated Hospital of Jinan University
  • Guangxi Medical University
  • Haikou People's Hospital
  • Hainan Cancer Hospital
  • Hunan Cancer Hospital
  • Peking University People's Hospital
  • Second Affiliated Hospital of Guangzhou Medical University
  • Shanghai Zhongshan Hospital
  • Shantou Central Hospital
  • Shenzhen People's Hospital
  • Shenzhen Third People's Hospital
  • The Third People's Hospital of Chengdu
  • The Third Xiangya Hospital of Central South University
  • Third Affiliated Hospital, Sun Yat-Sen University

Registry information

Official study title

Prediction of Growth Trend of Pulmonary Nodules Based on Multi-temporal and Multimodal Medical Data and Its Impact on Pulmonary Nodule Management Strategies

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Jun 13, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.