Adenocarcinoma of LungNCT05252676
Evaluation of Correlations Between Radiologic Features and Pathologic Subtypes of GGO LUAD Via WMS (ECTOP-1011)
An observational study of Adenocarcinoma of Lung, run by Fudan University at 1 site in China.
Trial summary
This study is one of the Eastern Cooperative Thoracic Oncology Projects (ECTOP-1011). It aims to evaluate the correlations between radiologic features and pathologic subtypes of ground glass opacity featured lung adenocarcinoma via whole-mount section. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of Lung
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Dec 2022
- 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: East Asian population
Who may be able to join
- Ground glass opacity featured lung nodule diagnosed by thin-section computed tomography(TSCT)
- Pre-operation clinical IA stage
- Pulmonary lobectomy or segmentectomy
- Provision of informed consent
Who cannot join
- Postoperative diagnosis of non-adenocarcinoma or mucinous adenocarcinoma
- The surgical specimens fail to satisfy requirement of inflation and formalin fixation
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Evaluation of Correlations Between Radiologic Features and Pathologic Subtypes of Ground Glass Opacity Featured Lung Adenocarcinoma Via Whole-Mount Section
This study is one of the Eastern Cooperative Thoracic Oncology Projects (ECTOP-1011). It aims to evaluate the correlations between radiologic features and pathologic subtypes of ground glass opacity featured lung adenocarcinoma via whole-mount section.
Read the detailed description
The pathological lepidic growth pattern was believed to relate to the ground-glass component, whereas invasive adenocarcinoma patterns relate to the solid component. However, the solid components might be fibrosis rather tumor; and previous studies demonstrated the ground-glass components might be invasive lesions. Therefore, it is of considerable significance to establish the correlations between radiologic features and pathologic subtypes of ground glass opacity featured lung adenocarcinoma.
- Conditions
- Adenocarcinoma of Lung
- Keywords
- Ground glass opacity
- 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 |
|---|---|---|
| Patients | Patients with ground glass opacity featured lung adenocarcinoma who are candidates for surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of correlations between radiologic features and pathologic subtypes
Evaluation of correlations between radiologic features and pathologic subtypes of ground glass opacity featured lung adenocarcinoma
Measured: about 14 days
Secondary outcomes (1)
Specificity, Sensitivity, and Repeatability
The specificity, sensitivity, and repeatability of invasiveness diagnosis based on the Whole-Mount Section
Measured: about 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Oct 2021
- Primary completion31 Aug 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma of LungStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
- Investigators
- Haiquan Chen, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252676
- Sponsor's protocol ID
- IRB2106237-23
- Status last verified
- Jul 2023
- First submitted
- 13 Feb 2022
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Noguchi M, Morikawa A, Kawasaki M, Matsuno Y, Yamada T, Hirohashi S, Kondo H, Shimosato Y. Small adenocarcinoma of the lung. Histologic characteristics and prognosis. Cancer. 1995 Jun 15;75(12):2844-52. doi: 10.1002/1097-0142(19950615)75:123.0.co;2-#.
PubMed 7773933Koike T, Terashima M, Takizawa T, Watanabe T, Kurita Y, Yokoyama A. Clinical analysis of small-sized peripheral lung cancer. J Thorac Cardiovasc Surg. 1998 May;115(5):1015-20. doi: 10.1016/S0022-5223(98)70399-X.
PubMed 9605069Suzuki K, Asamura H, Kusumoto M, Kondo H, Tsuchiya R. "Early" peripheral lung cancer: prognostic significance of ground glass opacity on thin-section computed tomographic scan. Ann Thorac Surg. 2002 Nov;74(5):1635-9. doi: 10.1016/s0003-4975(02)03895-x.
PubMed 12440622Suzuki K, Kusumoto M, Watanabe S, Tsuchiya R, Asamura H. Radiologic classification of small adenocarcinoma of the lung: radiologic-pathologic correlation and its prognostic impact. Ann Thorac Surg. 2006 Feb;81(2):413-9. doi: 10.1016/j.athoracsur.2005.07.058.
PubMed 16427823Travis WD, Asamura H, Bankier AA, Beasley MB, Detterbeck F, Flieder DB, Goo JM, MacMahon H, Naidich D, Nicholson AG, Powell CA, Prokop M, Rami-Porta R, Rusch V, van Schil P, Yatabe Y; International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee and Advisory Board Members. The IASLC Lung Cancer Staging Project: Proposals for Coding T Categories for Subsolid Nodules and Assessment of Tumor Size in Part-Solid Tumors in the Forthcoming Eighth Edition of the TNM Classification of Lung Cancer. J Thorac Oncol. 2016 Aug;11(8):1204-1223. doi: 10.1016/j.jtho.2016.03.025. Epub 2016 Apr 21.
PubMed 27107787Lim HJ, Ahn S, Lee KS, Han J, Shim YM, Woo S, Kim JH, Yie M, Lee HY, Yi CA. Persistent pure ground-glass opacity lung nodules >/= 10 mm in diameter at CT scan: histopathologic comparisons and prognostic implications. Chest. 2013 Oct;144(4):1291-1299. doi: 10.1378/chest.12-2987.
PubMed 23722583Suzuki K, Koike T, Asakawa T, Kusumoto M, Asamura H, Nagai K, Tada H, Mitsudomi T, Tsuboi M, Shibata T, Fukuda H, Kato H; Japan Lung Cancer Surgical Study Group (JCOG LCSSG). A prospective radiological study of thin-section computed tomography to predict pathological noninvasiveness in peripheral clinical IA lung cancer (Japan Clinical Oncology Group 0201). J Thorac Oncol. 2011 Apr;6(4):751-6. doi: 10.1097/JTO.0b013e31821038ab.
PubMed 21325976Son JY, Lee HY, Lee KS, Kim JH, Han J, Jeong JY, Kwon OJ, Shim YM. Quantitative CT analysis of pulmonary ground-glass opacity nodules for the distinction of invasive adenocarcinoma from pre-invasive or minimally invasive adenocarcinoma. PLoS One. 2014 Aug 7;9(8):e104066. doi: 10.1371/journal.pone.0104066. eCollection 2014.
PubMed 25102064Thunnissen E, Beasley MB, Borczuk AC, Brambilla E, Chirieac LR, Dacic S, Flieder D, Gazdar A, Geisinger K, Hasleton P, Ishikawa Y, Kerr KM, Lantejoul S, Matsuno Y, Minami Y, Moreira AL, Motoi N, Nicholson AG, Noguchi M, Nonaka D, Pelosi G, Petersen I, Rekhtman N, Roggli V, Travis WD, Tsao MS, Wistuba I, Xu H, Yatabe Y, Zakowski M, Witte B, Kuik DJ. Reproducibility of histopathological subtypes and invasion in pulmonary adenocarcinoma. An international interobserver study. Mod Pathol. 2012 Dec;25(12):1574-83. doi: 10.1038/modpathol.2012.106. Epub 2012 Jul 20.
PubMed 22814311Isaka T, Yokose T, Ito H, Imamura N, Watanabe M, Imai K, Nishii T, Woo T, Yamada K, Nakayama H, Masuda M. Comparison between CT tumor size and pathological tumor size in frozen section examinations of lung adenocarcinoma. Lung Cancer. 2014 Jul;85(1):40-6. doi: 10.1016/j.lungcan.2014.03.023. Epub 2014 Apr 1.
PubMed 24751107
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Correlations Between Radiologic Features and Pathologic Subtypes of Ground Glass Opacity Featured Lung Adenocarcinoma Via Whole-Mount Section
- ClinicalTrials.gov ID
- NCT05252676
- Acronym / sponsor ID
- IRB2106237-23
- Conditions
- Adenocarcinoma of Lung
- Keywords
- Ground glass opacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 23 Feb 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.
This study is one of the Eastern Cooperative Thoracic Oncology Projects (ECTOP-1011). It aims to evaluate the correlations between radiologic features and pathologic subtypes of ground glass opacity featured lung adenocarcinoma via whole-mount section.
Detailed description
The pathological lepidic growth pattern was believed to relate to the ground-glass component, whereas invasive adenocarcinoma patterns relate to the solid component. However, the solid components might be fibrosis rather tumor; and previous studies demonstrated the ground-glass components might be invasive lesions. Therefore, it is of considerable significance to establish the correlations between radiologic features and pathologic subtypes of ground glass opacity featured lung adenocarcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients with ground glass opacity featured lung adenocarcinoma who are candidates for surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- East Asian population
Key inclusion criteria (4 listed)
- Ground glass opacity featured lung nodule diagnosed by thin-section computed tomography(TSCT)
- Pre-operation clinical IA stage
- Pulmonary lobectomy or segmentectomy
- Provision of informed consent
Key exclusion criteria (2 listed)
- Postoperative diagnosis of non-adenocarcinoma or mucinous adenocarcinoma
- The surgical specimens fail to satisfy requirement of inflation and formalin fixation
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
Evaluation of correlations between radiologic features and pathologic subtypes
Time frame: about 14 days
Evaluation of correlations between radiologic features and pathologic subtypes of ground glass opacity featured lung adenocarcinoma
1 secondary outcome
Specificity, Sensitivity, and Repeatability
Time frame: about 14 days
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 21 Jul 2023.
- Background: PubMed 7773933Noguchi M, Morikawa A, Kawasaki M, Matsuno Y, Yamada T, Hirohashi S, Kondo H, Shimosato Y. Small adenocarcinoma of the lung. Histologic characteristics and prognosis. Cancer. 1995 Jun 15;75(12):2844-52. doi: 10.1002/1097-0142(19950615)75:123.0.co;2-#.
- Background: PubMed 9605069Koike T, Terashima M, Takizawa T, Watanabe T, Kurita Y, Yokoyama A. Clinical analysis of small-sized peripheral lung cancer. J Thorac Cardiovasc Surg. 1998 May;115(5):1015-20. doi: 10.1016/S0022-5223(98)70399-X.
- Background: PubMed 12440622Suzuki K, Asamura H, Kusumoto M, Kondo H, Tsuchiya R. "Early" peripheral lung cancer: prognostic significance of ground glass opacity on thin-section computed tomographic scan. Ann Thorac Surg. 2002 Nov;74(5):1635-9. doi: 10.1016/s0003-4975(02)03895-x.
- Background: PubMed 16427823Suzuki K, Kusumoto M, Watanabe S, Tsuchiya R, Asamura H. Radiologic classification of small adenocarcinoma of the lung: radiologic-pathologic correlation and its prognostic impact. Ann Thorac Surg. 2006 Feb;81(2):413-9. doi: 10.1016/j.athoracsur.2005.07.058.
- Background: PubMed 27107787Travis WD, Asamura H, Bankier AA, Beasley MB, Detterbeck F, Flieder DB, Goo JM, MacMahon H, Naidich D, Nicholson AG, Powell CA, Prokop M, Rami-Porta R, Rusch V, van Schil P, Yatabe Y; International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee and Advisory Board Members. The IASLC Lung Cancer Staging Project: Proposals for Coding T Categories for Subsolid Nodules and Assessment of Tumor Size in Part-Solid Tumors in the Forthcoming Eighth Edition of the TNM Classification of Lung Cancer. J Thorac Oncol. 2016 Aug;11(8):1204-1223. doi: 10.1016/j.jtho.2016.03.025. Epub 2016 Apr 21.
- Background: PubMed 23722583Lim HJ, Ahn S, Lee KS, Han J, Shim YM, Woo S, Kim JH, Yie M, Lee HY, Yi CA. Persistent pure ground-glass opacity lung nodules >/= 10 mm in diameter at CT scan: histopathologic comparisons and prognostic implications. Chest. 2013 Oct;144(4):1291-1299. doi: 10.1378/chest.12-2987.
- Background: PubMed 21325976Suzuki K, Koike T, Asakawa T, Kusumoto M, Asamura H, Nagai K, Tada H, Mitsudomi T, Tsuboi M, Shibata T, Fukuda H, Kato H; Japan Lung Cancer Surgical Study Group (JCOG LCSSG). A prospective radiological study of thin-section computed tomography to predict pathological noninvasiveness in peripheral clinical IA lung cancer (Japan Clinical Oncology Group 0201). J Thorac Oncol. 2011 Apr;6(4):751-6. doi: 10.1097/JTO.0b013e31821038ab.
- Background: PubMed 25102064Son JY, Lee HY, Lee KS, Kim JH, Han J, Jeong JY, Kwon OJ, Shim YM. Quantitative CT analysis of pulmonary ground-glass opacity nodules for the distinction of invasive adenocarcinoma from pre-invasive or minimally invasive adenocarcinoma. PLoS One. 2014 Aug 7;9(8):e104066. doi: 10.1371/journal.pone.0104066. eCollection 2014.
- Background: PubMed 22814311Thunnissen E, Beasley MB, Borczuk AC, Brambilla E, Chirieac LR, Dacic S, Flieder D, Gazdar A, Geisinger K, Hasleton P, Ishikawa Y, Kerr KM, Lantejoul S, Matsuno Y, Minami Y, Moreira AL, Motoi N, Nicholson AG, Noguchi M, Nonaka D, Pelosi G, Petersen I, Rekhtman N, Roggli V, Travis WD, Tsao MS, Wistuba I, Xu H, Yatabe Y, Zakowski M, Witte B, Kuik DJ. Reproducibility of histopathological subtypes and invasion in pulmonary adenocarcinoma. An international interobserver study. Mod Pathol. 2012 Dec;25(12):1574-83. doi: 10.1038/modpathol.2012.106. Epub 2012 Jul 20.
- Background: PubMed 24751107Isaka T, Yokose T, Ito H, Imamura N, Watanabe M, Imai K, Nishii T, Woo T, Yamada K, Nakayama H, Masuda M. Comparison between CT tumor size and pathological tumor size in frozen section examinations of lung adenocarcinoma. Lung Cancer. 2014 Jul;85(1):40-6. doi: 10.1016/j.lungcan.2014.03.023. Epub 2014 Apr 1.
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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.
Haiquan Chen, M.D. principal investigator
Fudan 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 Adenocarcinoma of Lung, run by Fudan University 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 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 21 Jul 2023. 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?
Evaluation of correlations between radiologic features and pathologic subtypes (time frame: about 14 days). 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 NCT05252676, which also lists 10 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 21 Jul 2023.