CompletedNCT05794698Updated Sep 3, 2024

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

An observational study in Lung Adenocarcinoma, Surgical Procedure, Unspecified and Pathology, sponsored by Fudan University. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2024-09-03.

Sponsored by Fudan University · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 827
Sex: All

Study 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.

Conditions studied

Lung Adenocarcinoma
Surgical Procedure, Unspecified
Pathology

Browse trials for

Adenocarcinoma of Lung 315

Keywords

Intraoperative frozen section pathology
surgical treatment
Lung adenocarcinoma

In context

Adenocarcinoma of Lung

315 studies on the registry are indexed under Adenocarcinoma of Lung; 83 are open to participants now.

This study's enrollment of 827 is above the median of 201 across 84 observational studies indexed under Adenocarcinoma of Lung.

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Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Observational model: Cohort
Time perspective: Prospective
Enrollment: 827 participants (actual)
Patient registry: No

Groups and cohorts

Study group
Clinical T1N0M0 lung adenocarcinoma patients eligible for surgery.
Procedure: Surgical resection

Interventions

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

What researchers measure

Primary outcomes

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.
Time frame: 2 years

Secondary outcomes

Concordance rate
Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of pleural invasion and lymph node invasion.
Time frame: 2 years
Concordance rate
Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of IASLC grades of lung adenocarcinoma
Time frame: 2 years
Concordance rate
Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of spread through air space (STAS).
Time frame: 2 years
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.
Time frame: 5 years
Overall survival (OS)
Overall survival (OS) is defined as the time from date of curative surgery to the time of death of any reason.
Time frame: 5 years

Study locations

1 site

Fudan University Cancer Center
Shanghai, Shanghai Municipality 200032, China

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2022 to primary completion in Jun 2024, 29 months.

Of 36 observational studies under Adenocarcinoma of Lung, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 65. This study's 29 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 8, 2023
First posted: Apr 3, 2023
StartActual: Jan 1, 2022
Primary completionActual: Jun 30, 2024
CompletionActual: Aug 30, 2024
Last update: Sep 3, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05794698
Lead sponsor: Fudan University
Collaborators: Shanghai Pulmonary Hospital, Shanghai, China, Tongji Hospital, Wuhan, Hubei Province, China, Sixth People's Hospital, Shanghai, China, Ningbo Clinical Pathological Diagnostic Center, Ningbo, Zhejiang Province, China, Dongfang Hospital Affiliated to Tongji University, Shanghai, China, People's Hospital of Jiangdu, Yangzhou, Jiangsu Province, China, Liaocheng People's Second Hospital, Liaocheng, Shandong Province, China, Guanxian People's Hospital, Liaocheng, Shandong Province, China, Zhoupu Hospital, Pudong New Area, Shanghai, China
Responsible party: Haiquan Chen (Professor, Fudan University) — Principal investigator
First posted: Apr 3, 2023
Start date: Jan 1, 2022
Primary completion: Jun 30, 2024
Completion: Aug 30, 2024
Last update: Sep 3, 2024

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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