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Trial Title:
Intraoperative Frozen Section Pathology to Guide Surgical Treatment for Lung Adenocarcinoma (ECTOP-1016)
NCT ID:
NCT05794724
Condition:
Lung Adenocarcinoma
Surgical Procedure, Unspecified
Pathology
Conditions: Official terms:
Adenocarcinoma
Adenocarcinoma of Lung
Conditions: Keywords:
Intraoperative frozen section pathology
Surgical treatment
Lung adenocarcinoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Surgical resection
Description:
Surgical resection of lung adenocarcinoma. Wedge resection, segmentectomy or lobectomy
will be performed according to each patients' condition.
Arm group label:
Clinical T1N0M0 lung adenocarcinoma patients eligible for surgery.
Summary:
This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1016). 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.
Criteria for eligibility:
Study pop:
Clinical stage T1N0M0 lung adenocarcinoma patients who are going to undergo surgical
resection.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Chen Haiquan, MD
Phone:
+86-21 64175590
Phone ext:
1707
Email:
hqchen1@yahoo.com
Start date:
January 1, 2022
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05794724
