Lung Cancer - Non Small CellNCT06908005
RaFIST: A Radiomics-Based Tool for Intratumoral Fibrosis Stratification in Non-Small Cell Lung Cancer
An observational study of Lung Cancer - Non Small Cell, run by Jinling Hospital, China at 1 site in China.
Trial summary
Patients with suspected Lung cancer who underwent contrast-enhanced CT and pathological examinations at Center 1 between January 2011 and January 2020 and Center 2 between September 2017 and Januray 2020 were eligible for inclusion in this study.The Clinical data, preoperative clinical information, laboratory results… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer - Non Small Cell
- What is being tested?
- CT radiomic analysis and Fibrosis assessment
- How many people
- 508 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Mar 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
- Adult, Older adult
Study population: Jinling Hospital, China
Who may be able to join
- Solid pulmonary nodule detected on CECT within 3 weeks pre-resection
- No history of previous treatment such as chemotherapy, or radiotherapy
Who cannot join
- Unavailable pathological sections
- Missing CT images or hard-to-annotate CT images
- Undergone anticancer therapy before CT
- Loss to follow-up
- Concurrent other malignant tumors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Prognostic Validation of RaFIST: A Radiomics-Based Tool for Intratumoral Fibrosis Stratification in Non-Small Cell Lung Cancer
Patients with suspected Lung cancer who underwent contrast-enhanced CT and pathological examinations at Center 1 between January 2011 and January 2020 and Center 2 between September 2017 and Januray 2020 were eligible for inclusion in this study.The Clinical data, preoperative clinical information, laboratory results, CT images and pathological sections were collected. The investigators also collected the disease-free survival and overall survival time. On the Deepwise multi-modal research platform, the images were semi-automatically segmented and PyRadiomics was used to extract the radiomic features. Fibrosis quantification was performed on picrosirius red (PSR)-stained tissue sections using color deconvolution and binarized collagen signal analysis in ImageJ software. The investigators developed RaFIST, a radiomics-based stratification tool, to noninvasively quantify intratumoral fibrosis in non-small cell lung cancer (NSCLC) using contrast-enhanced CT imaging. And it was further tested on the held-out external test cohort. Discrimination was assessed by using the C-index and area under the receiver operating characteristic curve (AUC).
- Conditions
- Lung Cancer - Non Small Cell
- Being tested
- CT radiomic analysis, Fibrosis assessment
- Keywords
- NSCLC, radiomics, PFS, fibrosis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT radiomic analysisOther
Radiomic features of tumor tissue
Fibrosis assessmentOther
Fibrosis quantification was performed on picrosirius red (PSR)-stained tissue sections using color deconvolution and binarized collagen signal analysis in ImageJ software (v1.5)
| Study group | Role | What they receive |
|---|---|---|
| training set | Not described Receives: Other: CT radiomic analysis; Other: Fibrosis assessment | |
| external test set | Not described Receives: Other: CT radiomic analysis; Other: Fibrosis assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS (Disease-free survival)
DFS was defined as the duration from the date of primary surgery to the first occurrence of recurrence or death from any cause.
Measured: Record from the date of surgery to the date of recurrence or death from any cause, whichever comes first, and assess up to a maximum of 5 years.
Secondary outcomes (1)
OS (overall survival）
Measured: Record from the date of surgery to the date of death from any cause，whichever comes first, and assess up to a maximum of 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 Apr 2024
- Primary completion1 Dec 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer - Non Small CellStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangming Lu, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908005
- Sponsor's protocol ID
- 2025-DZLC-02
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Prognostic Validation of RaFIST: A Radiomics-Based Tool for Intratumoral Fibrosis Stratification in Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06908005
- Acronym / sponsor ID
- 2025-DZLC-02
- Conditions
- Lung Cancer - Non Small Cell
- Keywords
- NSCLC, radiomics, PFS, fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 3 Apr 2025 (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.
Patients with suspected Lung cancer who underwent contrast-enhanced CT and pathological examinations at Center 1 between January 2011 and January 2020 and Center 2 between September 2017 and Januray 2020 were eligible for inclusion in this study.The Clinical data, preoperative clinical information, laboratory results, CT images and pathological sections were collected. The investigators also collected the disease-free survival and overall survival time. On the Deepwise multi-modal research platform, the images were semi-automatically segmented and PyRadiomics was used to extract the radiomic features. Fibrosis quantification was performed on picrosirius red (PSR)-stained tissue sections using color deconvolution and binarized collagen signal analysis in ImageJ software. The investigators developed RaFIST, a radiomics-based stratification tool, to noninvasively quantify intratumoral fibrosis in non-small cell lung cancer (NSCLC) using contrast-enhanced CT imaging. And it was further tested on the held-out external test cohort. Discrimination was assessed by using the C-index and area under the receiver operating characteristic curve (AUC).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training set | – | Other: CT radiomic analysis, Other: Fibrosis assessment |
| external test set | – | Other: CT radiomic analysis, Other: Fibrosis assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Jinling Hospital, China
Key inclusion criteria (2 listed)
- Solid pulmonary nodule detected on CECT within 3 weeks pre-resection
- No history of previous treatment such as chemotherapy, or radiotherapy
Key exclusion criteria (5 listed)
- Unavailable pathological sections
- Missing CT images or hard-to-annotate CT images
- Undergone anticancer therapy before CT
- Loss to follow-up
- Concurrent other malignant tumors
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 |
|---|---|---|
| CT radiomic analysisRadiomic features of tumor tissue | Other | external test set, training set |
| Fibrosis assessmentFibrosis quantification was performed on picrosirius red (PSR)-stained tissue sections using color deconvolution and binarized collagen signal analysis in ImageJ software (v1.5) | Other | external test set, training set |
Primary outcome
DFS (Disease-free survival)
Time frame: Record from the date of surgery to the date of recurrence or death from any cause, whichever comes first, and assess up to a maximum of 5 years.
DFS was defined as the duration from the date of primary surgery to the first occurrence of recurrence or death from any cause.
1 secondary outcome
OS (overall survival）
Time frame: Record from the date of surgery to the date of death from any cause，whichever comes first, and assess up to a maximum of 5 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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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.
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 - Non Small Cell, run by Jinling Hospital, China 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 8 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
DFS (Disease-free survival) (time frame: Record from the date of surgery to the date of recurrence or death from any cause, whichever comes first, and assess up to a maximum of 5 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 8 Apr 2025.