Evaluation of Correlations Between Radiologic Features and Pathologic Subtypes of GGO LUAD Via WMS (ECTOP-1011)

Adenocarcinoma of Lung Clinical Trial

Official title:

Evaluation of Correlations Between Radiologic Features and Pathologic Subtypes of Ground Glass Opacity Featured Lung Adenocarcinoma Via Whole-Mount Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05252676
• Other study ID #: IRB2106237-23
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 1, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Postoperative diagnosis of non-adenocarcinoma or mucinous adenocarcinoma
• The surgical specimens fail to satisfy requirement of inflation and formalin fixation

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung

Locations

Country	Name	City	State
China	Fudan University Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (10)

Isaka 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. — View Citation

Koike 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. — View Citation

Lim 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. — View Citation

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-#. — View Citation

Son 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. — View Citation

Suzuki 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. — View Citation

Suzuki 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. — View Citation

Suzuki 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. — View Citation

Thunnissen 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. — View Citation

Travis 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	about 14 days
Secondary	Specificity, Sensitivity, and Repeatability	The specificity, sensitivity, and repeatability of invasiveness diagnosis based on the Whole-Mount Section	about 14 days