ProgressionNCT05184829

A Single-center Study on the Effect of Systemic/Selective Lymph Node Dissection on the Prognosis of Ground Glass Nodules Smaller Than 3cm and With Components With Consolidation/Tumor Ratio Between 0.5-1

A study testing selective lymph node dissection and Systemic Lymph Node Dissection in people with Progression and Postoperative Recovery, run by Shanghai Zhongshan Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

A single-center study on the effect of systemic/selective lymph node dissection on the prognosis of ground glass nodules smaller than 3cm and with components with consolidation/tumor ratio between 0.5-1 Read more about this study

Who is it for?: Ages 25 to 75 years
Conditions the study is for: Progression, Postoperative Recovery
What is being tested?: selective lymph node dissection and Systemic Lymph Node Dissection
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: No sites listed yet
Study dates: 1 Jan 2022to 31 Dec 2029
Phase: Interventional
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 25 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients enrolled in the study must meet all of the following conditions:
1.Aged between 25 and 75 years;
2. GGO is diagnosed by thin-section lung CT (thickness <1.5mm) within one month before surgery;
3. The maximum diameter of the GGO is smaller than 3cm;
4. The solid component in GGO between 50%-100%;
5. Preoperative examination showed that the patient could tolerate lobectomy;
6. The patient is able to understand and comply with the study and has provided written informed consent.

Who cannot join

Patients meeting any of the following criteria are not eligible for this trial:
1. Patients with a history of lung surgery;
2. Postoperative pathology showed non-primary lung cancer;
3. The scope of surgical resection is larger than one lung lobe;
4. Patients with a history of other tumors;
5. Patients with severe complications (coronary heart disease, valvular heart disease, end-stage renal disease, severe liver cirrhosis);
6. Unable to cooperate with the researchers because of dementia or cognitive decline
7. Other situations that are not in conformity with the standards and requirements of this trial.

About this study

Read the detailed description

Conditions: Progression, Postoperative Recovery
Being tested: selective lymph node dissection, Systemic Lymph Node Dissection
Medical subject headings: Disease Progression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

selective lymph node dissectionOther
selective lymph node dissection
Systemic Lymph Node DissectionOther
Systemic Lymph Node Dissection

Study groups in NCT05184829
Study group	Role	What they receive
systemic lymph node dissection group	Active comparator	systemic lymph node dissection group Receives: Other: Systemic Lymph Node Dissection
selective lymph node dissection	Experimental	selective lymph node dissection Receives: Other: selective lymph node dissection

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall survival
Measured: From enrollment to 36 months after surgery

Secondary outcomes (1)

Complications
The degrees of cough
Measured: 1-2 Weeks after enrollment (after Surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202231 Dec 2029

First posted11 Jan 2022
Study start1 Jan 2022 (estimated)
Primary completion31 Dec 2028 (estimated)
Study completion31 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ProgressionStudies of the same condition, open and under way.
More trials run by Shanghai Zhongshan HospitalThe 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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: systemic or selective lymph node dissection group
Masking: None (open label)
Enrolment: 500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05184829
Sponsor's protocol ID: B2021
Status last verified: Dec 2021
First submitted: 15 Dec 2021
Last updated: 11 Jan 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center Study on the Effect of Systemic/Selective Lymph Node Dissection on the Prognosis of Ground Glass Nodules Smaller Than 3cm and With Components With Consolidation/Tumor Ratio Between 0.5-1
ClinicalTrials.gov ID: NCT05184829
Acronym / sponsor ID: B2021
Conditions: Progression, Postoperative Recovery
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 500 participants (estimated)
Lead sponsor: Shanghai Zhongshan HospitalUniversity, hospital or other
Study start: 1 Jan 2022 (estimated)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 31 Dec 2029 (estimated)
First posted: 11 Jan 2022 (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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: systemic or selective lymph node dissection group

Arm	Type	Receives
systemic lymph node dissection group	Active comparator	Other: Systemic Lymph Node Dissectionsystemic lymph node dissection group
selective lymph node dissection	Experimental	Other: selective lymph node dissectionselective lymph node dissection

Who may qualify

Ages: 25 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

1.Aged between 25 and 75 years;
2. GGO is diagnosed by thin-section lung CT (thickness <1.5mm) within one month before surgery;
3. The maximum diameter of the GGO is smaller than 3cm;
4. The solid component in GGO between 50%-100%;
5. Preoperative examination showed that the patient could tolerate lobectomy;

Key exclusion criteria (8 listed)

1. Patients with a history of lung surgery;
2. Postoperative pathology showed non-primary lung cancer;
3. The scope of surgical resection is larger than one lung lobe;
4. Patients with a history of other tumors;
5. Patients with severe complications (coronary heart disease, valvular heart disease, end-stage renal disease, severe liver cirrhosis);

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
selective lymph node dissectionselective lymph node dissection	Other	selective lymph node dissection
Systemic Lymph Node DissectionSystemic Lymph Node Dissection	Other	systemic lymph node dissection group

Primary outcome

Overall survival
Time frame: From enrollment to 36 months after surgery

1 secondary outcome

Complications
Time frame: 1-2 Weeks after enrollment (after Surgery)

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 11 Jan 2022.

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing selective lymph node dissection and Systemic Lymph Node Dissection in people with Progression and Postoperative Recovery, run by Shanghai Zhongshan Hospital.

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 8 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: opening soon, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: From enrollment to 36 months after surgery). 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 NCT05184829.

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 11 Jan 2022.