CarcinomaNCT05094882
Anatomical Location and Metastasis Pattern of Intrapulmonary Lymph Nodes in NSCLC (ECTOP-1010)
An observational study of Carcinoma and Non-small Cell Lung Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1010. Anatomical Location and Metastasis Pattern of Intrapulmonary Lymph Nodes (Group 11-13) in Non-small Cell Lung Cancer: a Multi-center, Prospective observational Clinical Trial Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Non-small Cell Lung Cancer
- What is being tested?
- pulmonary lobectomy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 30 Jun 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: Patients with stage T1 peripheral non-small cell lung cancer (NSCLC) undergoing radical lobectomy
Who may be able to join
- Preoperative examination showed patients with clinical T1 peripheral non-small cell lung cancer (NSCLC);
- The lesion is located in a single lung segment or between two adjacent lung segments;
- Perform radical lobectomy;
- The preoperative examination did not reveal unresectable lymph nodes;
- Have not received any other tumor-related treatments (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) before surgery;
- No malignant tumor history;
- No contraindications to surgery (ECOG score 0-1 points);
Who cannot join
- Pathology revealed patients with non-T1 stage non-small cell lung cancer (NSCLC);
- Radical lobectomy is not performed;
- Acception of any anti-tumor treatment before surgery (excluding Chinese medicine treatment);
- Refused to enter the group or asked to leave the group.
Trial locations and contacts
1 site in 1 country.
Hong Hu contact
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Center
Shanghai, Shanghai Municipality, 200032
Hong Hu, MD, +86-21 64175590 ext. 1707, hqchen1@yahoo.com
About this study
Official title: Anatomical Location and Metastasis Pattern of Intrapulmonary Lymph Nodes in Non-small Cell Lung Cancer: a Multi-center, Prospective Observational Clinical Trial
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1010. Anatomical Location and Metastasis Pattern of Intrapulmonary Lymph Nodes (Group 11-13) in Non-small Cell Lung Cancer: a Multi-center, Prospective observational Clinical Trial
Read the detailed description
Patients would be evaluated whether meet the criteria as clinical stage T1 non-small Cell Lung Cancer. Then, he/she would receive lobectomy. Finally, the detailed anatomical location of group 11-13 would be recorded immediately after surgery and their metastasis pattern would be explored in the follow-up period.
- Conditions
- Carcinoma, Non-small Cell Lung Cancer
- Being tested
- pulmonary lobectomy
- Keywords
- Non-small Cell Lung Cancer, Intrapulmonary Lymph Nodes, Anatomical Location, Metastasis Pattern
- Medical subject headings
- Carcinoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary lobectomyProcedure or surgery
resection of lung lobe
| Study group | Role | What they receive |
|---|---|---|
| RUL | patients who recieved the resection of right upper lobe (RUL) Receives: Procedure: pulmonary lobectomy | |
| RML | patients who recieved the resection of right middle lobe () Receives: Procedure: pulmonary lobectomy | |
| RLL | patients who recieved the resection of right lower lobe (RML) Receives: Procedure: pulmonary lobectomy | |
| LUL | patients who recieved the resection of left upper lobe (LUL) Receives: Procedure: pulmonary lobectomy | |
| LLL | patients who recieved the resection of left lower lobe (LLL) Receives: Procedure: pulmonary lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
metastasis rate of group 11-13 LN
metastasis rate of intrapulmonary lymph nodes (group 11-13 LN) in non-small cell lung cancer
Measured: one month after surgery
Secondary outcomes (1)
detailed anatomical location
number of group 11-13 intrapulmonary lymph nodes in Non-small cell lung cancer and their detailed anatomical location
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Dec 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
- Investigators
- Hong Hu, Principal investigator, Fudan University Affiliated Shanghai Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094882
- Sponsor's protocol ID
- ALMPILN
- Status last verified
- Jul 2023
- First submitted
- 4 Oct 2021
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Inform Consent Form, Clinical Study Report would be shared every 3 months after the study begin.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Location and Metastasis Pattern of Intrapulmonary Lymph Nodes in Non-small Cell Lung Cancer: a Multi-center, Prospective Observational Clinical Trial
- ClinicalTrials.gov ID
- NCT05094882
- Acronym / sponsor ID
- ALMPILN
- Conditions
- Carcinoma, Non-small Cell Lung Cancer
- Keywords
- Non-small Cell Lung Cancer, Intrapulmonary Lymph Nodes, Anatomical Location, Metastasis Pattern
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 26 Oct 2021 (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 is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1010. Anatomical Location and Metastasis Pattern of Intrapulmonary Lymph Nodes (Group 11-13) in Non-small Cell Lung Cancer: a Multi-center, Prospective observational Clinical Trial
Detailed description
Patients would be evaluated whether meet the criteria as clinical stage T1 non-small Cell Lung Cancer. Then, he/she would receive lobectomy. Finally, the detailed anatomical location of group 11-13 would be recorded immediately after surgery and their metastasis pattern would be explored in the follow-up period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| RUL | – | Procedure: pulmonary lobectomypatients who recieved the resection of right upper lobe (RUL) |
| RML | – | Procedure: pulmonary lobectomypatients who recieved the resection of right middle lobe () |
| RLL | – | Procedure: pulmonary lobectomypatients who recieved the resection of right lower lobe (RML) |
| LUL | – | Procedure: pulmonary lobectomypatients who recieved the resection of left upper lobe (LUL) |
| LLL | – | Procedure: pulmonary lobectomypatients who recieved the resection of left lower lobe (LLL) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with stage T1 peripheral non-small cell lung cancer (NSCLC) undergoing radical lobectomy
Key inclusion criteria (7 listed)
- Preoperative examination showed patients with clinical T1 peripheral non-small cell lung cancer (NSCLC);
- The lesion is located in a single lung segment or between two adjacent lung segments;
- Perform radical lobectomy;
- The preoperative examination did not reveal unresectable lymph nodes;
- Have not received any other tumor-related treatments (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) before surgery;
Key exclusion criteria (4 listed)
- Pathology revealed patients with non-T1 stage non-small cell lung cancer (NSCLC);
- Radical lobectomy is not performed;
- Acception of any anti-tumor treatment before surgery (excluding Chinese medicine treatment);
- Refused to enter the group or asked to leave the group.
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 |
|---|---|---|
| pulmonary lobectomyresection of lung lobe | Procedure or surgery | LLL, LUL, RLL, RML, RUL |
Primary outcome
metastasis rate of group 11-13 LN
Time frame: one month after surgery
metastasis rate of intrapulmonary lymph nodes (group 11-13 LN) in non-small cell lung cancer
1 secondary outcome
detailed anatomical location
Time frame: immediately after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: Yes. Study Protocol, Inform Consent Form, Clinical Study Report would be shared every 3 months after the study begin.
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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.
Hong Hu contact
Hong Hu principal investigator
Fudan University Affiliated Shanghai Cancer Center
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 Carcinoma and Non-small Cell Lung Cancer, 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 7 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 20 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 hong hu (86-13512102066, huhong0997@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metastasis rate of group 11-13 LN (time frame: one month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2023.