ClinicalTrials.gg
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

In context

Solitary Pulmonary Nodule

93 studies on the registry are indexed under Solitary Pulmonary Nodule; 20 are open to participants now.

This study's planned enrollment of 1,184 is above the median of 401 across 45 observational studies indexed under Solitary Pulmonary Nodule.

Browse Solitary Pulmonary Nodule studies →

Lead sponsor

Guangdong Provincial People's Hospital is the lead sponsor of 237 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
  • 0~2
  • Able to provide CT in DICOM format
  • obtained

Exclusion criteria

Exclusion Criteria:

  • Long-term use of and hormone drugs
  • History of previous (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 less than 6 months
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,184 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
06

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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06458673
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 ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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