Intraoperative Frozen Section Pathology to Guide Surgical Treatment for Lung Adenocarcinoma (ECTOP-1016)

NCT ID: NCT05794724

Last Updated: 2023-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1063 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Adenocarcinoma Surgical Procedure, Unspecified Pathology

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clinical T1N0M0 lung adenocarcinoma patients eligible for surgery.

Surgical resection

Intervention Type PROCEDURE

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

Interventions

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Surgical resection

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Haiquan Chen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fudan University Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yue Zhao, M.D., Ph.D.

Role: CONTACT

+86 18801735510

Facility Contacts

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Chen Haiquan, MD

Role: primary

+86-21 64175590 ext. 1707

Other Identifiers

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CONCORD-C

Identifier Type: -

Identifier Source: org_study_id

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