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Completed

NCT Number: NCT05794698

Intraoperative Frozen Section Pathology to Diagnose the IASLC Grades for Lung Adenocarcinoma (ECTOP-1014)

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.

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Key information

Conditions

Lung Adenocarcinoma Adenocarcinoma Adenocarcinoma of Lung Carcinoma Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathology Respiratory Tract Neoplasms Surgical Procedure, Unspecified Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgical resection

Procedure

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

Primary outcomes

  1. Concordance rate

    Time frame: 2 years

    Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of lung adenocarcinoma subtypes according to the WHO classifications.

Secondary outcomes

  1. Concordance rate

    Time frame: 2 years

    Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of pleural invasion and lymph node invasion.

  2. Concordance rate

    Time frame: 2 years

    Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of IASLC grades of lung adenocarcinoma

  3. Concordance rate

    Time frame: 2 years

    Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of spread through air space (STAS).

  4. Recurrence-free survival (RFS)

    Time frame: 5 years

    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. Overall survival (OS)

    Time frame: 5 years

    Overall survival (OS) is defined as the time from date of curative surgery to the time of death of any reason.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • Dongfang Hospital Affiliated to Tongji University, Shanghai, China
  • Guanxian People's Hospital, Liaocheng, Shandong Province, China
  • Liaocheng People's Second Hospital, Liaocheng, Shandong Province, China
  • Minhang Hospital Affiliated to Fudan University, Shanghai, China
  • Ningbo Clinical Pathological Diagnostic Center, Ningbo, Zhejiang Province, China
  • People's Hospital of Jiangdu, Yangzhou, Jiangsu Province, China
  • Shanghai Pulmonary Hospital, Shanghai, China
  • Sixth People's Hospital, Shanghai, China
  • Tongji Hospital, Wuhan, Hubei Province, China
  • Zhoupu Hospital, Pudong New Area, Shanghai, China

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2023
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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