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Not yet recruitingNCT06458673Updated Dec 2, 2024

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

An observational study in Solitary Lung Nodule and Multiple Pulmonary Nodules, sponsored by Guangdong Provincial People's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-02.

Sponsored by Guangdong Provincial People's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,184
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Solitary Lung Nodule
  • Multiple Pulmonary Nodules

Keywords

  • Lung Nodule
  • Prospective
  • Observational Study
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with subsolid pulmonary nodules of 5 to 30 mm in size found on CT

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,184 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. 5-year growth rate of subsolid pulmonary nodules

    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.

    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

Secondary outcomes

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

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

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

  2. Lung cancer-specific 5-year survival rate

    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

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

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

    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

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

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

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

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

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Study locations

1 site
  • Guangdong Provincial People's Hospital
    Guangzhou, Guangdong 510080, China
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Registry details

Key details

Study ID
NCT06458673
Lead sponsor
Guangdong Provincial People's Hospital
Collaborators
Third Affiliated Hospital, Sun Yat-Sen University, Fifth Affiliated Hospital, Sun Yat-Sen University, Peking University People's Hospital, Guangxi Medical University, Shanghai Zhongshan Hospital, The Third Xiangya Hospital of Central South University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, The Third People's Hospital of Chengdu, Shantou Central Hospital, Hainan Cancer Hospital, Shenzhen People's Hospital, Hunan Cancer Hospital, Shenzhen Third People's Hospital, First Affiliated Hospital of Jinan University, Haikou People's Hospital, Second Affiliated Hospital of Guangzhou Medical University
Responsible party
Xue-Ning Yang (Vice-Chief of Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital) — Principal investigator
First posted
Jun 13, 2024
Start date
Dec 1, 2024 (estimated)
Primary completion
Nov 30, 2030 (estimated)
Completion
Nov 30, 2030 (estimated)
Last update
Dec 2, 2024

Study contacts

Xuening Yang, MD
Contact
yangxncn@qq.com
0086-13922713300
Xuening Yang, MD
principal investigator · Guangdong Provincial People's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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