Lung AdenocarcinomaNCT06745830
Lymph Node Pathologic Grading Strategy
An observational study of Lung Adenocarcinoma, run by Fudan University at 1 site in China.
Trial summary
The percentage of high-grade patterns in metastatic LNs (mLNs) that can predict poor outcomes has yet to be determined. Additionally, the potential implications of other histologic patterns in metastatic lymph nodes on patient outcomes warrant further investigation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Adenocarcinoma
- How many people
- 2,998 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2024to 20 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: From January 2011 to September 2021, we consecutively collected patients with invasive LUAD who underwent surgical resection at the Department of Thoracic Surgery, Fudan University Shanghai Cancer Center.Exclusion criteria were the following: (1) adenocarcinoma in situ, minimally invasive adenocarcinoma, invasive mucinous adenocarcinoma, and other variants of adenocarcinoma; (2) incomplete common driver mutation data; and (3) unavailable pathologic slides.
Who may be able to join
- From January 2011 to September 2021, we consecutively collected patients with invasive LUAD who underwent surgical resection at the Department of Thoracic Surgery, Fudan University Shanghai Cancer Center.
Who cannot join
- adenocarcinoma in situ, minimally invasive adenocarcinoma, invasive mucinous adenocarcinoma, and other variants of adenocarcinoma;
- incomplete common driver mutation data;
- unavailable pathologic slides.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhu wangyang Zhu, 13301970795, 20301050177@fudan.edu.cn
About this study
Official title: Lymph Node Pathologic Grading Strategy: Under the Backdrop of the IASLC Grading System for Invasive Lung Adenocarcinoma - a Retrospective Cohort Study
The percentage of high-grade patterns in metastatic LNs (mLNs) that can predict poor outcomes has yet to be determined. Additionally, the potential implications of other histologic patterns in metastatic lymph nodes on patient outcomes warrant further investigation.
We conducted a retrospective cohort study to investigate the prognostic value of pathologic pattern in metastatic lymph nodes.
- Conditions
- Lung Adenocarcinoma
- Being tested
- No intervention
- 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.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Invasive LUAD who underwent surgical resection | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year RFS
Measured: 5 years
Secondary outcomes (1)
5-year OS
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 posted20 Dec 2024
- Study start10 Apr 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion20 Apr 2025 (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
- Retrospective
- Enrolment
- 2,998 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
- NCT06745830
- Sponsor's protocol ID
- FUSCCLN1203
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhu W, Deng C, Wang Y, Fu F, Lin Y, Li Y, Zhang Y, Chen H. Lymph Node Pathologic Grading Strategy: Under the Backdrop of the IASLC Grading System for Invasive Lung Adenocarcinoma - A Retrospective Cohort Study Among Asian Patients. J Thorac Oncol. 2026 Sep 4:104184. doi: 10.1016/j.jtho.2026.104184. Online ahead of print.
PubMed 42697511
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymph Node Pathologic Grading Strategy: Under the Backdrop of the IASLC Grading System for Invasive Lung Adenocarcinoma - a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06745830
- Acronym / sponsor ID
- FUSCCLN1203
- Conditions
- Lung Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,998 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 20 Apr 2025 (estimated)
- First posted
- 20 Dec 2024 (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.
The percentage of high-grade patterns in metastatic LNs (mLNs) that can predict poor outcomes has yet to be determined. Additionally, the potential implications of other histologic patterns in metastatic lymph nodes on patient outcomes warrant further investigation.
We conducted a retrospective cohort study to investigate the prognostic value of pathologic pattern in metastatic lymph nodes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invasive LUAD who underwent surgical resection | – | Other: No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From January 2011 to September 2021, we consecutively collected patients with invasive LUAD who underwent surgical resection at the Department of Thoracic Surgery, Fudan University Shanghai Cancer Center.Exclusion criteria were the following: (1) adenocarcinoma in situ, minimally invasive adenocarcinoma, invasive mucinous adenocarcinoma, and other variants of adenocarcinoma; (2) incomplete common driver mutation data; and (3) unavailable pathologic slides.
Key inclusion criteria (1 listed)
- From January 2011 to September 2021, we consecutively collected patients with invasive LUAD who underwent surgical resection at the Department of Thoracic Surgery, Fudan University Shanghai Cancer Center.
Key exclusion criteria (3 listed)
- adenocarcinoma in situ, minimally invasive adenocarcinoma, invasive mucinous adenocarcinoma, and other variants of adenocarcinoma;
- incomplete common driver mutation data;
- unavailable pathologic slides.
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 |
|---|---|---|
| No interventionNo intervention | Other | Invasive LUAD who underwent surgical resection |
Primary outcome
5-year RFS
Time frame: 5 years
1 secondary outcome
5-year OS
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Derived from this study: PubMed 42697511Zhu W, Deng C, Wang Y, Fu F, Lin Y, Li Y, Zhang Y, Chen H. Lymph Node Pathologic Grading Strategy: Under the Backdrop of the IASLC Grading System for Invasive Lung Adenocarcinoma - A Retrospective Cohort Study Among Asian Patients. J Thorac Oncol. 2026 Sep 4:104184. doi: 10.1016/j.jtho.2026.104184. Online ahead of print.
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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.
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, 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhu (13301970795, 20301050177@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year RFS (time frame: 5 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 NCT06745830, 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 20 Dec 2024.