Lung CancerNCT06500312
Decoding the Association of Imaging and Tumor Microenvironment in Lung Cancer Using Radiogenomic Approach（Radiogenomics-Lung）
An observational study of Lung Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This is the prospective, observational cohort study (Radiogenomics-Lung), which aims to explore the relationship between the imaging information of lung cancer patients, tumor microenvironment and the prognosis of lung cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2024to 2 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients were treated for lung cancer
Who may be able to join
- Patients were treated for lung cancer in Wuhan Union Hospital from July 2024 to July 2027;
- Aged > 18 years old;
- At least one chest CT scan before treatment;
- Tissue biopsy pathological examination confirmed the diagnosis of the above tumors.
Who cannot join
- Poor image quality;
- Incomplete clinical data or loss of follow-up;
- Presence of another primary malignancy other than lung cancer;
- Unclear pathological diagnosis。
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital，Tongji Medical College，Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Lian Yang, 18986273791, yanglian@hust.edu.cn
About this study
Official title: Assessment the Association of Imaging and Tumor Microenvironment in Lung Cancer With Radiogenomics
This is the prospective, observational cohort study (Radiogenomics-Lung), which aims to explore the relationship between the imaging information of lung cancer patients, tumor microenvironment and the prognosis of lung cancer patients.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation analysis of sequencing results and body composition
Conducting correlation analysis between body composition and results of multi-omics sequencing
Measured: 0.5 year
Correlation analysis of sequencing results and tumor radiomic features
Conducting correlation analysis between radiomic features and results of multi-omics sequencing
Measured: 0.5 year
Secondary outcomes (2)
Constructing tumor microenvironment prediction model
Constructing radiomic model to predict tumor microenvironment. The indicator is the area under the curve (AUC) of the prediction model
Measured: 2 years
Constructing a multi-dimensional prognostic prediction model
A high-dimensional model was constructed to predict the prognosis of patients through multi-omics sequencing data, body composition, and tumor radiomic features. The indicator is the area under the curve (AUC) of the prediction model.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start2 Jul 2024
- Primary completion2 Jul 2027 (estimated)
- Study completion2 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500312
- Sponsor's protocol ID
- 0482
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 13 Jan 2025
- 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment the Association of Imaging and Tumor Microenvironment in Lung Cancer With Radiogenomics
- ClinicalTrials.gov ID
- NCT06500312
- Acronym / sponsor ID
- 0482
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 2 Jul 2027 (estimated)
- Study completion
- 2 Jul 2027 (estimated)
- First posted
- 15 Jul 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.
This is the prospective, observational cohort study (Radiogenomics-Lung), which aims to explore the relationship between the imaging information of lung cancer patients, tumor microenvironment and the prognosis of lung cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were treated for lung cancer
Key inclusion criteria (4 listed)
- Patients were treated for lung cancer in Wuhan Union Hospital from July 2024 to July 2027;
- Aged > 18 years old;
- At least one chest CT scan before treatment;
- Tissue biopsy pathological examination confirmed the diagnosis of the above tumors.
Key exclusion criteria (4 listed)
- Poor image quality;
- Incomplete clinical data or loss of follow-up;
- Presence of another primary malignancy other than lung cancer;
- Unclear pathological diagnosis。
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
Correlation analysis of sequencing results and body composition
Time frame: 0.5 year
Conducting correlation analysis between body composition and results of multi-omics sequencing
Correlation analysis of sequencing results and tumor radiomic features
Time frame: 0.5 year
Conducting correlation analysis between radiomic features and results of multi-omics sequencing
2 secondary outcomes
Constructing tumor microenvironment prediction model
Time frame: 2 years
Constructing a multi-dimensional prognostic prediction model
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
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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.
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 Lung Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lian Yang (18986273791, yanglian@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation analysis of sequencing results and body composition (time frame: 0.5 year). 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 13 Jan 2025.