Lung AdenocarcinomaNCT05400304
Radiomics Combined With Frozen Section Prediction Model for Spread Through Air Space in Lung Adenocarcinoma
An observational study of Lung Adenocarcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
a multifactorial model combining radiomics with frozen section analysis is a potential biomarker for assessing Spread Through Air Space during surgery, which can provide decision-making support to therapeutic planning for early-stage lung adenocarcinomas. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Adenocarcinoma
- What is being tested?
- radiomics
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 12 May 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pulmonary nodules in the collaborating institutes.
Who may be able to join
- intraoperative frozen section diagnosis and final pathology diagnosis are available
- preoperative standard non-enhanced CT is available
- Pathologically confirmed
Who cannot join
- with a previous history of radiation therapy, chemotherapy or biopsy
- the time interval between the CT examination and surgery was more than two weeks
About this study
Official title: Preoperative CT-based Radiomics Combined With Intraoperative Frozen Section is Predictive of Spread Through Air Space in Early Lung Adenocarcinoma
a multifactorial model combining radiomics with frozen section analysis is a potential biomarker for assessing Spread Through Air Space during surgery, which can provide decision-making support to therapeutic planning for early-stage lung adenocarcinomas.
Read the detailed description
Spread through air space (STAS) is a novel invasive pattern of lung adenocarcinoma and is also a risk factor for recurrence and worse prognosis of lung adenocarcinoma. Its preoperative assessment could thus be useful to customize surgical treatment. Radiomics and frozen section haave been recently proposed to predict STAS in patients with lung adenocarcinoma. Radiomics-based Prediction Model is highly sensitive but not specific for STAS detection. While, frozen section is highly specific but not sensitive for STAS detection in early lung adenocarcinomas.
Therefore, the proposed project aims to develop and validate a multifactorial model combining radiomics with frozen section analysis to assesse Spread Through Air Space during surgery, which can provide decision-making support to therapeutic planning for early-stage lung adenocarcinomas.
- Conditions
- Lung Adenocarcinoma
- Being tested
- radiomics
- Keywords
- Spread Through Air Space, radiomics, frozen section, Prediction Model
- 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.
radiomicsDiagnostic test
The high-throughput extraction of large amounts of quantitative image features from medical images
| Study group | Role | What they receive |
|---|---|---|
| Training dataset | No interventions Receives: Diagnostic Test: radiomics | |
| External validation1 | No interventions Receives: Diagnostic Test: radiomics | |
| External validation2 | No interventions Receives: Diagnostic Test: radiomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Testing the sensitivity of Radiomics to predict STAS using the area under receiver operating characteristic curve
Measured: 24 hour before operation
Specificity
Testing the specificity of Radiomics to predict STAS using the area under receiver operating characteristic curve
Measured: 24 hour before operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion12 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400304
- Sponsor's protocol ID
- RFSTAS
- Status last verified
- Jun 2022
- First submitted
- 26 May 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative CT-based Radiomics Combined With Intraoperative Frozen Section is Predictive of Spread Through Air Space in Early Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05400304
- Acronym / sponsor ID
- RFSTAS
- Conditions
- Lung Adenocarcinoma
- Keywords
- Spread Through Air Space, radiomics, frozen section, Prediction Model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 12 May 2023 (estimated)
- First posted
- 1 Jun 2022 (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.
a multifactorial model combining radiomics with frozen section analysis is a potential biomarker for assessing Spread Through Air Space during surgery, which can provide decision-making support to therapeutic planning for early-stage lung adenocarcinomas.
Detailed description
Spread through air space (STAS) is a novel invasive pattern of lung adenocarcinoma and is also a risk factor for recurrence and worse prognosis of lung adenocarcinoma. Its preoperative assessment could thus be useful to customize surgical treatment. Radiomics and frozen section haave been recently proposed to predict STAS in patients with lung adenocarcinoma. Radiomics-based Prediction Model is highly sensitive but not specific for STAS detection. While, frozen section is highly specific but not sensitive for STAS detection in early lung adenocarcinomas.
Therefore, the proposed project aims to develop and validate a multifactorial model combining radiomics with frozen section analysis to assesse Spread Through Air Space during surgery, which can provide decision-making support to therapeutic planning for early-stage lung adenocarcinomas.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training dataset | – | Diagnostic Test: radiomicsNo interventions |
| External validation1 | – | Diagnostic Test: radiomicsNo interventions |
| External validation2 | – | Diagnostic Test: radiomicsNo interventions |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pulmonary nodules in the collaborating institutes.
Key inclusion criteria (3 listed)
- intraoperative frozen section diagnosis and final pathology diagnosis are available
- preoperative standard non-enhanced CT is available
- Pathologically confirmed
Key exclusion criteria (2 listed)
- with a previous history of radiation therapy, chemotherapy or biopsy
- the time interval between the CT examination and surgery was more than two weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiomicsThe high-throughput extraction of large amounts of quantitative image features from medical images | Diagnostic test | External validation1, External validation2, Training dataset |
Primary outcome
Sensitivity
Time frame: 24 hour before operation
Testing the sensitivity of Radiomics to predict STAS using the area under receiver operating characteristic curve
Specificity
Time frame: 24 hour before operation
Testing the specificity of Radiomics to predict STAS using the area under receiver operating characteristic curve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Adenocarcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 3 inclusion and 2 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 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 24 hour before operation). The study lists 2 primary outcomes in all. 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 29 Jun 2022.