NCT05794698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
827

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

2.5 years

First QC Date

March 8, 2023

Last Update Submit

August 29, 2024

Conditions

Lung AdenocarcinomaSurgical Procedure, UnspecifiedPathology

Keywords

Intraoperative frozen section pathologysurgical treatmentLung adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Concordance rate

    2 years

  • Concordance rate

    2 years

  • Concordance rate

    2 years

  • Recurrence-free survival (RFS)

    5 years

  • Overall survival (OS)

    5 years

Study Arms (1)

Study group

Clinical T1N0M0 lung adenocarcinoma patients eligible for surgery.

Procedure: Surgical resection

Interventions

Surgical resectionPROCEDURE

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

Study group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinical stage T1N0M0 lung adenocarcinoma patients who are going to undergo surgical resection.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by Site

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 8, 2023

First Posted

April 3, 2023

Study Start

January 1, 2022

Primary Completion

June 30, 2024

Study Completion

August 30, 2024

Last Updated

September 3, 2024

Record last verified: 2024-08

Locations

CN(1)