Lung AdenocarcinomaNCT05794711
Intraoperative Frozen Section Pathology to Guide Surgical Treatment for Lung Adenocarcinoma (ECTOP-1015)
An observational study of Lung Adenocarcinoma and Surgical Procedure, Unspecified, run by Fudan University at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Adenocarcinoma, Surgical Procedure, Unspecified, Pathology
- What is being tested?
- Surgical resection
- Type of treatment
- Surgery or procedure
- How many people
- 1,063 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Clinical stage T1N0M0 lung adenocarcinoma patients who are going to undergo surgical resection.
Who may be able to join
- 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.
Who cannot join
- Patients with clinical stages other than T1N0M0;
- The lesion cannot be completely resected;
- Previous history of cancer;
- Patients having received radiation therapy or chemotherapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Center
Shanghai, Shanghai Municipality, 200032
Chen Haiquan, MD, +86-21 64175590 ext. 1707, hqchen1@yahoo.com
About this study
Official title: Concordance Between Intraoperative Frozen Section Pathology and Postoperative Paraffin-embedded Pathology in Diagnosing the IASLC Grade of Lung Adenocarcinoma
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.
- Being tested
- Surgical resection
- Keywords
- Intraoperative frozen section pathology, Surgical treatment, Lung adenocarcinoma
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical resectionProcedure or surgery
Surgical resection of lung adenocarcinoma. Wedge resection, segmentectomy or lobectomy will be performed according to each patients' condition.
| Study group | Role | What they receive |
|---|---|---|
| Clinical T1N0M0 lung adenocarcinoma patients eligible for surgery. | Not described Receives: Procedure: Surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance rate
Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of IASLC grades of lung adenocarcinoma
Measured: 2 years
Secondary outcomes (5)
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.
Measured: 2 years
Concordance rate
Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of pleural invasion and lymph node invasion.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,063 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794711
- Sponsor's protocol ID
- CONCORD-B
- Status last verified
- Jul 2023
- First submitted
- 8 Mar 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fu Z, Shen X, Deng C, Cao H, Jin Y, Zheng Q, Yang Y, Qian B, Yuan C, Wang W, Zhang L, Song Q, Zuo S, Ma J, You S, Zheng S, Gao Q, Su G, Zhang Y, Fu F, Chen H, Li Y. Prediction of the pathological subtypes by intraoperative frozen section for patients with cT1N0M0 invasive lung adenocarcinoma (ECTOP-1015): a prospective multicenter study. Int J Surg. 2024 Sep 1;110(9):5444-5451. doi: 10.1097/JS9.0000000000001667.
PubMed 38781043
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance Between Intraoperative Frozen Section Pathology and Postoperative Paraffin-embedded Pathology in Diagnosing the IASLC Grade of Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05794711
- Acronym / sponsor ID
- CONCORD-B
- Keywords
- Intraoperative frozen section pathology, Surgical treatment, Lung adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,063 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical T1N0M0 lung adenocarcinoma patients eligible for surgery. | – | Procedure: Surgical resection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinical stage T1N0M0 lung adenocarcinoma patients who are going to undergo surgical resection.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- Patients with clinical stages other than T1N0M0;
- The lesion cannot be completely resected;
- Previous history of cancer;
- Patients having received radiation therapy or chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical resectionSurgical resection of lung adenocarcinoma. Wedge resection, segmentectomy or lobectomy will be performed according to each patients' condition. | Procedure or surgery | Clinical T1N0M0 lung adenocarcinoma patients eligible for surgery. |
Primary outcome
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
5 secondary outcomes
Concordance rate
Time frame: 2 years
Concordance rate
Time frame: 2 years
Concordance rate
Time frame: 2 years
Recurrence-free survival (RFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Derived from this study: PubMed 38781043Fu Z, Shen X, Deng C, Cao H, Jin Y, Zheng Q, Yang Y, Qian B, Yuan C, Wang W, Zhang L, Song Q, Zuo S, Ma J, You S, Zheng S, Gao Q, Su G, Zhang Y, Fu F, Chen H, Li Y. Prediction of the pathological subtypes by intraoperative frozen section for patients with cT1N0M0 invasive lung adenocarcinoma (ECTOP-1015): a prospective multicenter study. Int J Surg. 2024 Sep 1;110(9):5444-5451. doi: 10.1097/JS9.0000000000001667.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Adenocarcinoma and Surgical Procedure, Unspecified, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yue Zhao, M.D., Ph.D. (+86 18801735510, yuezhao97@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05794711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.