Tomography, X-Ray ComputedNCT06645743
Retrospective Analysis of Clinical and CT Features to Predict Spread Through Air Space in Stage IA Lung Adenocarcinoma
An observational study of Tomography, X-Ray Computed and Spread Through Air Space, run by The Third Affiliated Hospital of Kunming Medical College. at 1 site in China.
Trial summary
The purpose of this study is to provide a basis for the selection of surgical methods for patients with stage IA lung adenocarcinoma. Air cavity dissemination is a poor prognostic factor for patients with stage IA lung adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tomography, X-Ray Computed, Spread Through Air Space, Clinical Features
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2024to 21 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be selected from patients diagnosed with Stage IA lung adenocarcinoma after surgery who have undergone preoperative evaluation of clinical and CT imaging at the Third Affiliated Hospital of Kunming Medical University within the past five years
Who may be able to join
- Preoperative CT images reported that the maximum diameter of pulmonary nodules was less than 3 cm
- All subjects provided CT imaging obtained from Yunnan Cancer Hospital within a 2-week period prior to surgery
- Postoperative pathological diagnosis of invasive lung adenocarcinoma
- Remote metastasis was excluded by preoperative imaging (CT, PET-CT, ultrasound, etc.)
- Age ≥ 18 years
Who cannot join
- Incomplete collection of medical records, imaging data, or hematology data
- Preoperative complications of other malignant tumors
- Unclear correspondence between postoperative pathological report and preoperative CT nodule location
- Images do not meet analysis conditions due to pulmonary infection or large respiratory motion artifacts
- Postoperative pathology revealed two or more nodules classified as infiltrating adenocarcinoma
- Prior lung surgery or preoperative neoadjuvant therapy
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000
Lianhua Ye, +86 13508801068, Lhye1204@aliyun.com
Yaowu Duan, +86 19086653462, 34763399775@qq.com
About this study
Official title: Clinical and Imaging Features Were Used to Predict the Occurrence of Spread Through Air Space in Stage IA Lung Adenocarcinoma
The purpose of this study is to provide a basis for the selection of surgical methods for patients with stage IA lung adenocarcinoma. Air cavity dissemination is a poor prognostic factor for patients with stage IA lung adenocarcinoma. We retrospectively collected clinical and imaging data of stage IA lung adenocarcinoma patients. Independent risk factors associated with spread through air space in stage IA lung adenocarcinoma patients were analyzed, so as to predict the occurrence of spread through air space and provide basis for the selection of surgical methods
Read the detailed description
Referring from Global Cancer Report 2020, lung cancer remains the leading cause of tumor death, with adenocarcinoma as the primary histological subtype. In 2021, the World Health Organization (WHO) proposed a new classification standard for lung cancer, dividing adenocarcinomas into in-situ adenocarcinomas, microinvasive adenocarcinomas, and invasive adenocarcinomas based on their invasive development.
Due to the widespread popularization of early screening for lung cancer, a growing number of IA lung adenocarcinomas cases manifesting as lung nodules have been detected, and surgical resection remains the most critical treatment options for such individuals. With the emergence of relevant research results, sublobectomy has become a preferred method for early stage IA lung adenocarcinoma. However, some individuals with lung adenocarcinoma in stage IA undergoing sublobectomy still have recurrence and metastasis, in which spread through air spaces (STAS) plays vital role.
STAS was formally proposed by WHO in 2015 as a new invasion mode of invasive lung adenocarcinoma. STAS is characterized by pathological micropapillary clusters, solid nests, or isolated cells located beyond the tumor margin, counting one or more, infiltrating the air spaces within the surrounding lung parenchyma and detached from the primary tumor, rather than forming distinct tumor islands. A number of studies have pointed out that STAS is associated with poor prognosis of patients, many researchers continue to favor lobectomy when treating patients with stage IA lung adenocarcinoma exhibiting positive STAS.
Due to the limitations of intraoperative frozen section in predicting STAS, preoperative application of clinical and imaging features in predicting STAS shows great advantages. Former research has suggested that clinical and imaging characteristics can predict occurrence of STAS, despite the difference of results from different studies. Onozato et al. believe that smokers are more likely to develop STAS, which is consistent with the study by Shiono et al. However, Uruga et albelieved that the occurrence of STAS was unrelated to smoking. Warth et al. believed that male lung adenocarcinoma patients were more prone to STAS, while Kadota stated the occurrence of STAS was unrelated to patient gender.
However, the sample size included in these previous studies is small, and the parameters included by various scholars are different, and there is still a lack of large sample studies systematically analyzing clinical and imaging characteristics to predict the spread through air space of stage IA lung adenocarcinoma. Therefore, we plan to carry out this study. Based on a large sample size, the clinical and imaging characteristics of patients with stage IA lung adenocarcinoma were comprehensively analyzed to predict the spread through air space, so as to provide a reference for the selection of surgical methods
- Conditions
- Tomography, X-Ray Computed, Spread Through Air Space, Clinical Features, Stage IA Adenocarcinoma of Lung
- Keywords
- clinical feature, Radiologic characteristic, Lung adenocarcinoma, spread through air space
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| spread through air space positive group | The patients in this group were stage IA lung adenocarcinoma patients who met the inclusion and exclusion criteria, and the postoperative pathological results indicated the presence of spread through air space | |
| spread through air space negative group | The patients in this group were stage IA lung adenocarcinoma patients who met the inclusion and exclusion criteria, and the postoperative pathological results showed no spread through air space |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Predicting Spread Through Air Spaces (STAS) in Stage IA Lung Adenocarcinoma Using Clinical and Imaging Features
This outcome measure assesses the accuracy of using preoperative clinical and CT imaging features to predict the presence of spread through air spaces (STAS) in patients with stage IA lung adenocarcinoma.Measure: Area Under the ROC Curve (AUC), sensitivity, and specificity for the prediction model.
Measured: Preoperative clinical and imaging data collected within 2 weeks prior to surgery, retrospectively analyzed from patients who underwent surgery within the past 3 years
Secondary outcomes (1)
Prognostic Impact of STAS on Recurrence-Free Survival
This outcome measure investigates whether the presence of STAS in stage IA lung adenocarcinoma is associated with recurrence-free survival (RFS).
Measured: From the date of surgery to the time of disease recurrence or last follow-up, up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start25 Oct 2024 (estimated)
- Primary completion21 Feb 2025 (estimated)
- Study completion21 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tomography, X-Ray ComputedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated Hospital of Kunming Medical College.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yantao Yang, The Third Affiliated Hospital of Kunming Medical College.
- Investigators
- Lianhua Ye, Study director, The Third Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645743
- Sponsor's protocol ID
- KYLX2023-137
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and/or analyzed during the current study are not publicly available due sharing data is not included in our research institution review board but are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Imaging Features Were Used to Predict the Occurrence of Spread Through Air Space in Stage IA Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06645743
- Acronym / sponsor ID
- KYLX2023-137
- Conditions
- Tomography, X-Ray Computed, Spread Through Air Space, Clinical Features, Stage IA Adenocarcinoma of Lung
- Keywords
- clinical feature, Radiologic characteristic, Lung adenocarcinoma, spread through air space
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- The Third Affiliated Hospital of Kunming Medical College.University, hospital or other
- Study start
- 25 Oct 2024 (estimated)
- Primary completion
- 21 Feb 2025 (estimated)
- Study completion
- 21 Feb 2025 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to provide a basis for the selection of surgical methods for patients with stage IA lung adenocarcinoma. Air cavity dissemination is a poor prognostic factor for patients with stage IA lung adenocarcinoma. We retrospectively collected clinical and imaging data of stage IA lung adenocarcinoma patients. Independent risk factors associated with spread through air space in stage IA lung adenocarcinoma patients were analyzed, so as to predict the occurrence of spread through air space and provide basis for the selection of surgical methods
Detailed description
Referring from Global Cancer Report 2020, lung cancer remains the leading cause of tumor death, with adenocarcinoma as the primary histological subtype. In 2021, the World Health Organization (WHO) proposed a new classification standard for lung cancer, dividing adenocarcinomas into in-situ adenocarcinomas, microinvasive adenocarcinomas, and invasive adenocarcinomas based on their invasive development.
Due to the widespread popularization of early screening for lung cancer, a growing number of IA lung adenocarcinomas cases manifesting as lung nodules have been detected, and surgical resection remains the most critical treatment options for such individuals. With the emergence of relevant research results, sublobectomy has become a preferred method for early stage IA lung adenocarcinoma. However, some individuals with lung adenocarcinoma in stage IA undergoing sublobectomy still have recurrence and metastasis, in which spread through air spaces (STAS) plays vital role.
STAS was formally proposed by WHO in 2015 as a new invasion mode of invasive lung adenocarcinoma. STAS is characterized by pathological micropapillary clusters, solid nests, or isolated cells located beyond the tumor margin, counting one or more, infiltrating the air spaces within the surrounding lung parenchyma and detached from the primary tumor, rather than forming distinct tumor islands. A number of studies have pointed out that STAS is associated with poor prognosis of patients, many researchers continue to favor lobectomy when treating patients with stage IA lung adenocarcinoma exhibiting positive STAS.
Due to the limitations of intraoperative frozen section in predicting STAS, preoperative application of clinical and imaging features in predicting STAS shows great advantages. Former research has suggested that clinical and imaging characteristics can predict occurrence of STAS, despite the difference of results from different studies. Onozato et al. believe that smokers are more likely to develop STAS, which is consistent with the study by Shiono et al. However, Uruga et albelieved that the occurrence of STAS was unrelated to smoking. Warth et al. believed that male lung adenocarcinoma patients were more prone to STAS, while Kadota stated the occurrence of STAS was unrelated to patient gender.
However, the sample size included in these previous studies is small, and the parameters included by various scholars are different, and there is still a lack of large sample studies systematically analyzing clinical and imaging characteristics to predict the spread through air space of stage IA lung adenocarcinoma. Therefore, we plan to carry out this study. Based on a large sample size, the clinical and imaging characteristics of patients with stage IA lung adenocarcinoma were comprehensively analyzed to predict the spread through air space, so as to provide a reference for the selection of surgical methods
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spread through air space positive group | – | –The patients in this group were stage IA lung adenocarcinoma patients who met the inclusion and exclusion criteria, and the postoperative pathological results indicated the presence of spread through air space |
| spread through air space negative group | – | –The patients in this group were stage IA lung adenocarcinoma patients who met the inclusion and exclusion criteria, and the postoperative pathological results showed no spread through air space |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from patients diagnosed with Stage IA lung adenocarcinoma after surgery who have undergone preoperative evaluation of clinical and CT imaging at the Third Affiliated Hospital of Kunming Medical University within the past five years
Key inclusion criteria (5 listed)
- Preoperative CT images reported that the maximum diameter of pulmonary nodules was less than 3 cm
- All subjects provided CT imaging obtained from Yunnan Cancer Hospital within a 2-week period prior to surgery
- Postoperative pathological diagnosis of invasive lung adenocarcinoma
- Remote metastasis was excluded by preoperative imaging (CT, PET-CT, ultrasound, etc.)
- Age ≥ 18 years
Key exclusion criteria (6 listed)
- Incomplete collection of medical records, imaging data, or hematology data
- Preoperative complications of other malignant tumors
- Unclear correspondence between postoperative pathological report and preoperative CT nodule location
- Images do not meet analysis conditions due to pulmonary infection or large respiratory motion artifacts
- Postoperative pathology revealed two or more nodules classified as infiltrating adenocarcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of Predicting Spread Through Air Spaces (STAS) in Stage IA Lung Adenocarcinoma Using Clinical and Imaging Features
Time frame: Preoperative clinical and imaging data collected within 2 weeks prior to surgery, retrospectively analyzed from patients who underwent surgery within the past 3 years
This outcome measure assesses the accuracy of using preoperative clinical and CT imaging features to predict the presence of spread through air spaces (STAS) in patients with stage IA lung adenocarcinoma.Measure: Area Under the ROC Curve (AUC), sensitivity, and specificity for the prediction model.
1 secondary outcome
Prognostic Impact of STAS on Recurrence-Free Survival
Time frame: From the date of surgery to the time of disease recurrence or last follow-up, up to 5 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Provides global information and statistics on lung cancerLink provided by the sponsor.
- A free search engine providing access to a vast collection of biomedical and life sciences literature, including MEDLINE-indexed articles, covering topics such as medicine, pharmacology, and healthcare research.Link provided by the sponsor.
- The Third Affiliated Hospital of Kunming Medical University provides comprehensive cancer care, including surgery, radiotherapy, chemotherapy, and immunotherapy, along with advanced diagnostic and imaging services.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The datasets generated and/or analyzed during the current study are not publicly available due sharing data is not included in our research institution review board but are available from the corresponding author on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lianhua Ye study director
The Third Affiliated Hospital of Kunming Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tomography, X-Ray Computed and Spread Through Air Space, run by The Third Affiliated Hospital of Kunming Medical College. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yantao Yang (+86 18288509115, 2443804244@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Predicting Spread Through Air Spaces (STAS) in Stage IA Lung Adenocarcinoma Using Clinical and Imaging Features (time frame: Preoperative clinical and imaging data collected within 2 weeks prior to surgery, retrospectively analyzed from patients who underwent surgery within the past 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.