Clinical trial NCT05794698: Intraoperative Frozen Section Pathology to Diagnose the IASLC Grades for Lung Adenocarcinoma (ECTOP-1014)
Official title: Concordance Between Intraoperative Frozen Section and Postoperative Pathology in Diagnosing the IASLC Grades and Guiding the Surgical Procedure of Lung Adenocarcinoma: a Multi-center Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Adenocarcinoma
Surgical Procedure, Unspecified
Pathology
Keywords: Intraoperative frozen section pathology
surgical treatment
Lung adenocarcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Pulmonary Hospital, Shanghai, China
name: Tongji Hospital, Wuhan, Hubei Province, China
name: Sixth People's Hospital, Shanghai, China
name: Ningbo Clinical Pathological Diagnostic Center, Ningbo, Zhejiang Province, China
name: Dongfang Hospital Affiliated to Tongji University, Shanghai, China
name: Minhang Hospital Affiliated to Fudan University, Shanghai, China
name: People's Hospital of Jiangdu, Yangzhou, Jiangsu Province, China
name: Liaocheng People's Second Hospital, Liaocheng, Shandong Province, China
name: Guanxian People's Hospital, Liaocheng, Shandong Province, China
name: Zhoupu Hospital, Pudong New Area, Shanghai, China
First posted: 2023-04-03
Enrollment: 827
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical stage T1N0M0 lung adenocarcinoma patients who are going to undergo surgical resection.

Brief summary: This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1014). The goal of this clinical trial is to confirm the concordance rate between intra-operative frozen section pathological diagnosis and post-operative paraffin embedded pathological diagnosis, and use this result to guide surgical treatment for early stage (cT1N0M0) lung adenocarcinomas.


Eligibility criteria: Inclusion Criteria:

* Patients who sign the informed consent form and are willing to complete the study according to the study protocol;
* No previous history of cancer or pulmonary surgery;
* Solitary lesions or multiple lesions with only one not manifesting as pure ground-glass opacity (GGO) on CT scan;
* Peripheral clinical T1N0M0 patients that are eligible for surgery;
* Non-small cell lung cancer is pathologically diagnosed before or at surgery;
* No radiation therapy or chemotherapy before surgery.

Exclusion Criteria:

* Patients with clinical stages other than T1N0M0;
* The lesion cannot be completely resected;
* Previous history of cancer;
* Patients having received radiation therapy or chemotherapy.

Primary outcomes:
measure: Concordance rate
timeFrame: 2 years
Secondary outcomes:
measure: Concordance rate
timeFrame: 2 years
measure: Concordance rate
timeFrame: 2 years
measure: Concordance rate
timeFrame: 2 years
measure: Recurrence-free survival (RFS)
timeFrame: 5 years
measure: Overall survival (OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Center
state: Shanghai
Study officials:
References: