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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05794711
Other study ID # CONCORD-B
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2024

Study information

Verified date July 2023
Source Fudan University
Contact Yue Zhao, M.D., Ph.D.
Phone +86 18801735510
Email yuezhao97@outlook.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1015). 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1063
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

Procedure:
Surgical resection
Surgical resection of lung adenocarcinoma. Wedge resection, segmentectomy or lobectomy will be performed according to each patients' condition.

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, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concordance rate Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of IASLC grades of lung adenocarcinoma 2 years
Secondary Concordance rate Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of lung adenocarcinoma subtypes according to the WHO classifications. 2 years
Secondary Concordance rate Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of pleural invasion and lymph node invasion. 2 years
Secondary Concordance rate Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of spread through air space (STAS). 2 years
Secondary Recurrence-free survival (RFS) Recurrence-free survival (RFS) is defined as the time from date of curative surgery to the time of recurrence or death, whichever comes first. 5 years
Secondary Overall survival (OS) Overall survival (OS) is defined as the time from date of curative surgery to the time of death of any reason. 5 years
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