Lung Cancer, Nonsmall CellNCT06405815
A Radiomic Model for Risk of Local Recurrence and DFS for T3 and T4 Non-small Cell Lung Cancer
An observational study of Lung Cancer, Nonsmall Cell, run by Jinling Hospital, China at 1 site in China.
Trial summary
The investigators retrospectively collected the participants with T3 and T4, N0-2, M0 NSCLC patients resected between January 2013 to December 2021 for training and internal validation. The Clinical data, preoperative laboratory results and images were collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Nonsmall Cell
- What is being tested?
- tumor and peritumor radiomic feature
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 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 years and older
- All sexes
- Adult, Older adult
Study population: All T3 and T4 non-small cell lung cancers with surgery, and we retrospectively collected the preoperative enhanced chest CT and the recurrence location and time.
Who may be able to join
- patients with T3 and T4 stage NSCLC；
- available preoperative chest CTE within two weeks of surgery
Who cannot join
- inadequate imaging quality resulted from breathing artifact;
- without regularly follow-up information on recurrence location and time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Tumor and Peritumor Radiomics-based Model to Predict the High-risk Surgical Margin and Prognosis of T3 and T4 Non-Small Cell Lung Cancer
The investigators retrospectively collected the participants with T3 and T4, N0-2, M0 NSCLC patients resected between January 2013 to December 2021 for training and internal validation. The Clinical data, preoperative laboratory results and images were collected. High-risk margins were defined as R1 or R2 surgical margins or local recurrence during follow-up, and the investigators also collected the disease-free survival time. On the Deepwise multi-modal research platform, the images were semi-automatically segmented and expanded outward by 3mm to obtain the peritumor tissue. PyRadiomics was used to extract the radiomic features. LASSO was used to select the features and tumor radiomics model, peritumor model and combined model were built using 5-fold cross-validation. And it was further tested on the independent cohort. Discrimination was assessed by using the C-index and area under the receiver operating characteristic curve (AUC), sensibility, specificity.
- Conditions
- Lung Cancer, Nonsmall Cell
- Being tested
- tumor and peritumor radiomic feature
- Keywords
- non-small cell lung cancer, surgical margin, DFS, radiomics
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumor and peritumor radiomic featureOther
extracted the tumor and peritumor radiomic feature from the preoperative enhanced chest CT
| Study group | Role | What they receive |
|---|---|---|
| high-risk surgical margin | High-risk margins were defined as R1 or R2 surgical margins or local recurrence during follow-up. Receives: Other: tumor and peritumor radiomic feature | |
| Low-risk surgical margin | Low-risk margins were defined as R0 surgical margin meanwhile arising distant metastasis during follow-up. Receives: Other: tumor and peritumor radiomic feature |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free time and recurrence location
the time from the surgery time to the recurrence time
Measured: until the December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer, Nonsmall 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
- 200 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
- Investigators
- Guangming Lu, Study director, Department of Radiology, Jinling Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405815
- Sponsor's protocol ID
- JinlingHospital_lungcancer
- Status last verified
- May 2024
- First submitted
- 4 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang EH, Corso CD, Rutter CE, Park HS, Chen AB, Kim AW, Wilson LD, Decker RH, Yu JB. Postoperative Radiation Therapy Is Associated With Improved Overall Survival in Incompletely Resected Stage II and III Non-Small-Cell Lung Cancer. J Clin Oncol. 2015 Sep 1;33(25):2727-34. doi: 10.1200/JCO.2015.61.1517. Epub 2015 Jun 22.
PubMed 26101240Gillies RJ, Kinahan PE, Hricak H. Radiomics: Images Are More than Pictures, They Are Data. Radiology. 2016 Feb;278(2):563-77. doi: 10.1148/radiol.2015151169. Epub 2015 Nov 18.
PubMed 26579733Huang Y, Liu Z, He L, Chen X, Pan D, Ma Z, Liang C, Tian J, Liang C. Radiomics Signature: A Potential Biomarker for the Prediction of Disease-Free Survival in Early-Stage (I or II) Non-Small Cell Lung Cancer. Radiology. 2016 Dec;281(3):947-957. doi: 10.1148/radiol.2016152234. Epub 2016 Jun 27.
PubMed 27347764Yang H, Wang L, Shao G, Dong B, Wang F, Wei Y, Li P, Chen H, Chen W, Zheng Y, He Y, Zhao Y, Du X, Sun X, Wang Z, Wang Y, Zhou X, Lai X, Feng W, Shen L, Qiu G, Ji Y, Chen J, Jiang Y, Liu J, Zeng J, Wang C, Zhao Q, Yang X, Hu X, Ma H, Chen Q, Chen M, Jiang H, Xu Y. A combined predictive model based on radiomics features and clinical factors for disease progression in early-stage non-small cell lung cancer treated with stereotactic ablative radiotherapy. Front Oncol. 2022 Aug 2;12:967360. doi: 10.3389/fonc.2022.967360. eCollection 2022.
PubMed 35982975She Y, He B, Wang F, Zhong Y, Wang T, Liu Z, Yang M, Yu B, Deng J, Sun X, Wu C, Hou L, Zhu Y, Yang Y, Hu H, Dong D, Chen C, Tian J. Deep learning for predicting major pathological response to neoadjuvant chemoimmunotherapy in non-small cell lung cancer: A multicentre study. EBioMedicine. 2022 Dec;86:104364. doi: 10.1016/j.ebiom.2022.104364. Epub 2022 Nov 14.
PubMed 36395737Sawabata N, Matsumura A, Ohota M, Maeda H, Hirano H, Nakagawa K, Matsuda H; Thoracic Surgery Study Group of Osaka University. Cytologically malignant margins of wedge resected stage I non-small cell lung cancer. Ann Thorac Surg. 2002 Dec;74(6):1953-7. doi: 10.1016/s0003-4975(02)03993-0.
PubMed 12643379Akinci D'Antonoli T, Farchione A, Lenkowicz J, Chiappetta M, Cicchetti G, Martino A, Ottavianelli A, Manfredi R, Margaritora S, Bonomo L, Valentini V, Larici AR. CT Radiomics Signature of Tumor and Peritumoral Lung Parenchyma to Predict Nonsmall Cell Lung Cancer Postsurgical Recurrence Risk. Acad Radiol. 2020 Apr;27(4):497-507. doi: 10.1016/j.acra.2019.05.019. Epub 2019 Jul 6.
PubMed 31285150Ohguri T, Yahara K, Moon SD, Yamaguchi S, Imada H, Hanagiri T, Tanaka F, Terashima H, Korogi Y. Postoperative radiotherapy for incompletely resected non-small cell lung cancer: clinical outcomes and prognostic value of the histological subtype. J Radiat Res. 2012;53(2):319-25. doi: 10.1269/jrr.11082. Epub 2012 Feb 13.
PubMed 22327172Hancock JG, Rosen JE, Antonicelli A, Moreno A, Kim AW, Detterbeck FC, Boffa DJ. Impact of adjuvant treatment for microscopic residual disease after non-small cell lung cancer surgery. Ann Thorac Surg. 2015 Feb;99(2):406-13. doi: 10.1016/j.athoracsur.2014.09.033. Epub 2014 Dec 17.
PubMed 25528723Sawabata N, Maeda H, Matsumura A, Ohta M, Okumura M; Thoracic Surgery Study Group of Osaka University. Clinical implications of the margin cytology findings and margin/tumor size ratio in patients who underwent pulmonary excision for peripheral non-small cell lung cancer. Surg Today. 2012 Feb;42(3):238-44. doi: 10.1007/s00595-011-0031-6. Epub 2011 Nov 10.
PubMed 22072149Qi LL, Wang JW, Yang L, Huang Y, Zhao SJ, Tang W, Jin YJ, Zhang ZW, Zhou Z, Yu YZ, Wang YZ, Wu N. Natural history of pathologically confirmed pulmonary subsolid nodules with deep learning-assisted nodule segmentation. Eur Radiol. 2021 Jun;31(6):3884-3897. doi: 10.1007/s00330-020-07450-z. Epub 2020 Nov 21.
PubMed 33219848Kelsey CR, Marks LB, Hollis D, Hubbs JL, Ready NE, D'Amico TA, Boyd JA. Local recurrence after surgery for early stage lung cancer: an 11-year experience with 975 patients. Cancer. 2009 Nov 15;115(22):5218-27. doi: 10.1002/cncr.24625.
PubMed 19672942Zwanenburg A, Vallieres M, Abdalah MA, Aerts HJWL, Andrearczyk V, Apte A, Ashrafinia S, Bakas S, Beukinga RJ, Boellaard R, Bogowicz M, Boldrini L, Buvat I, Cook GJR, Davatzikos C, Depeursinge A, Desseroit MC, Dinapoli N, Dinh CV, Echegaray S, El Naqa I, Fedorov AY, Gatta R, Gillies RJ, Goh V, Gotz M, Guckenberger M, Ha SM, Hatt M, Isensee F, Lambin P, Leger S, Leijenaar RTH, Lenkowicz J, Lippert F, Losnegard A, Maier-Hein KH, Morin O, Muller H, Napel S, Nioche C, Orlhac F, Pati S, Pfaehler EAG, Rahmim A, Rao AUK, Scherer J, Siddique MM, Sijtsema NM, Socarras Fernandez J, Spezi E, Steenbakkers RJHM, Tanadini-Lang S, Thorwarth D, Troost EGC, Upadhaya T, Valentini V, van Dijk LV, van Griethuysen J, van Velden FHP, Whybra P, Richter C, Lock S. The Image Biomarker Standardization Initiative: Standardized Quantitative Radiomics for High-Throughput Image-based Phenotyping. Radiology. 2020 May;295(2):328-338. doi: 10.1148/radiol.2020191145. Epub 2020 Mar 10.
PubMed 32154773
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Tumor and Peritumor Radiomics-based Model to Predict the High-risk Surgical Margin and Prognosis of T3 and T4 Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06405815
- Acronym / sponsor ID
- JinlingHospital_lungcancer
- Conditions
- Lung Cancer, Nonsmall Cell
- Keywords
- non-small cell lung cancer, surgical margin, DFS, radiomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 May 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 investigators retrospectively collected the participants with T3 and T4, N0-2, M0 NSCLC patients resected between January 2013 to December 2021 for training and internal validation. The Clinical data, preoperative laboratory results and images were collected. High-risk margins were defined as R1 or R2 surgical margins or local recurrence during follow-up, and the investigators also collected the disease-free survival time. On the Deepwise multi-modal research platform, the images were semi-automatically segmented and expanded outward by 3mm to obtain the peritumor tissue. PyRadiomics was used to extract the radiomic features. LASSO was used to select the features and tumor radiomics model, peritumor model and combined model were built using 5-fold cross-validation. And it was further tested on the independent cohort. Discrimination was assessed by using the C-index and area under the receiver operating characteristic curve (AUC), sensibility, specificity.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-risk surgical margin | – | Other: tumor and peritumor radiomic featureHigh-risk margins were defined as R1 or R2 surgical margins or local recurrence during follow-up. |
| Low-risk surgical margin | – | Other: tumor and peritumor radiomic featureLow-risk margins were defined as R0 surgical margin meanwhile arising distant metastasis during follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All T3 and T4 non-small cell lung cancers with surgery, and we retrospectively collected the preoperative enhanced chest CT and the recurrence location and time.
Key inclusion criteria (2 listed)
- patients with T3 and T4 stage NSCLC；
- available preoperative chest CTE within two weeks of surgery
Key exclusion criteria (2 listed)
- inadequate imaging quality resulted from breathing artifact;
- without regularly follow-up information on recurrence location and time
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 |
|---|---|---|
| tumor and peritumor radiomic featureextracted the tumor and peritumor radiomic feature from the preoperative enhanced chest CT | Other | Low-risk surgical margin, high-risk surgical margin |
Primary outcome
disease free time and recurrence location
Time frame: until the December 2023
the time from the surgery time to the recurrence time
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 9 May 2024.
- Background: PubMed 26101240Wang EH, Corso CD, Rutter CE, Park HS, Chen AB, Kim AW, Wilson LD, Decker RH, Yu JB. Postoperative Radiation Therapy Is Associated With Improved Overall Survival in Incompletely Resected Stage II and III Non-Small-Cell Lung Cancer. J Clin Oncol. 2015 Sep 1;33(25):2727-34. doi: 10.1200/JCO.2015.61.1517. Epub 2015 Jun 22.
- Background: PubMed 26579733Gillies RJ, Kinahan PE, Hricak H. Radiomics: Images Are More than Pictures, They Are Data. Radiology. 2016 Feb;278(2):563-77. doi: 10.1148/radiol.2015151169. Epub 2015 Nov 18.
- Background: PubMed 27347764Huang Y, Liu Z, He L, Chen X, Pan D, Ma Z, Liang C, Tian J, Liang C. Radiomics Signature: A Potential Biomarker for the Prediction of Disease-Free Survival in Early-Stage (I or II) Non-Small Cell Lung Cancer. Radiology. 2016 Dec;281(3):947-957. doi: 10.1148/radiol.2016152234. Epub 2016 Jun 27.
- Background: PubMed 35982975Yang H, Wang L, Shao G, Dong B, Wang F, Wei Y, Li P, Chen H, Chen W, Zheng Y, He Y, Zhao Y, Du X, Sun X, Wang Z, Wang Y, Zhou X, Lai X, Feng W, Shen L, Qiu G, Ji Y, Chen J, Jiang Y, Liu J, Zeng J, Wang C, Zhao Q, Yang X, Hu X, Ma H, Chen Q, Chen M, Jiang H, Xu Y. A combined predictive model based on radiomics features and clinical factors for disease progression in early-stage non-small cell lung cancer treated with stereotactic ablative radiotherapy. Front Oncol. 2022 Aug 2;12:967360. doi: 10.3389/fonc.2022.967360. eCollection 2022.
- Background: PubMed 36395737She Y, He B, Wang F, Zhong Y, Wang T, Liu Z, Yang M, Yu B, Deng J, Sun X, Wu C, Hou L, Zhu Y, Yang Y, Hu H, Dong D, Chen C, Tian J. Deep learning for predicting major pathological response to neoadjuvant chemoimmunotherapy in non-small cell lung cancer: A multicentre study. EBioMedicine. 2022 Dec;86:104364. doi: 10.1016/j.ebiom.2022.104364. Epub 2022 Nov 14.
- Background: PubMed 12643379Sawabata N, Matsumura A, Ohota M, Maeda H, Hirano H, Nakagawa K, Matsuda H; Thoracic Surgery Study Group of Osaka University. Cytologically malignant margins of wedge resected stage I non-small cell lung cancer. Ann Thorac Surg. 2002 Dec;74(6):1953-7. doi: 10.1016/s0003-4975(02)03993-0.
- Background: PubMed 31285150Akinci D'Antonoli T, Farchione A, Lenkowicz J, Chiappetta M, Cicchetti G, Martino A, Ottavianelli A, Manfredi R, Margaritora S, Bonomo L, Valentini V, Larici AR. CT Radiomics Signature of Tumor and Peritumoral Lung Parenchyma to Predict Nonsmall Cell Lung Cancer Postsurgical Recurrence Risk. Acad Radiol. 2020 Apr;27(4):497-507. doi: 10.1016/j.acra.2019.05.019. Epub 2019 Jul 6.
- Results publication: PubMed 22327172Ohguri T, Yahara K, Moon SD, Yamaguchi S, Imada H, Hanagiri T, Tanaka F, Terashima H, Korogi Y. Postoperative radiotherapy for incompletely resected non-small cell lung cancer: clinical outcomes and prognostic value of the histological subtype. J Radiat Res. 2012;53(2):319-25. doi: 10.1269/jrr.11082. Epub 2012 Feb 13.
- Results publication: PubMed 25528723Hancock JG, Rosen JE, Antonicelli A, Moreno A, Kim AW, Detterbeck FC, Boffa DJ. Impact of adjuvant treatment for microscopic residual disease after non-small cell lung cancer surgery. Ann Thorac Surg. 2015 Feb;99(2):406-13. doi: 10.1016/j.athoracsur.2014.09.033. Epub 2014 Dec 17.
- Results publication: PubMed 22072149Sawabata N, Maeda H, Matsumura A, Ohta M, Okumura M; Thoracic Surgery Study Group of Osaka University. Clinical implications of the margin cytology findings and margin/tumor size ratio in patients who underwent pulmonary excision for peripheral non-small cell lung cancer. Surg Today. 2012 Feb;42(3):238-44. doi: 10.1007/s00595-011-0031-6. Epub 2011 Nov 10.
- Results publication: PubMed 33219848Qi LL, Wang JW, Yang L, Huang Y, Zhao SJ, Tang W, Jin YJ, Zhang ZW, Zhou Z, Yu YZ, Wang YZ, Wu N. Natural history of pathologically confirmed pulmonary subsolid nodules with deep learning-assisted nodule segmentation. Eur Radiol. 2021 Jun;31(6):3884-3897. doi: 10.1007/s00330-020-07450-z. Epub 2020 Nov 21.
- Results publication: PubMed 19672942Kelsey CR, Marks LB, Hollis D, Hubbs JL, Ready NE, D'Amico TA, Boyd JA. Local recurrence after surgery for early stage lung cancer: an 11-year experience with 975 patients. Cancer. 2009 Nov 15;115(22):5218-27. doi: 10.1002/cncr.24625.
- Individual participant dataSharing planned: Undecided
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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.
Guangming Lu study director
Department of Radiology, Jinling Hospital
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, Nonsmall 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 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: finished, as of the sponsor's last update on 9 May 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?
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?
disease free time and recurrence location (time frame: until the December 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06405815, which also lists 13 linked publications.
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 9 May 2024.