Lung Ground-glass OpacitiesNCT06394037
Active Surveillance for Limited GGNs
An observational study of Lung Ground-glass Opacities and Active Surveillance, run by Fudan University at 1 site in China.
Trial summary
This study is a single-arm, multi-center, phase III trial conducted under the Eastern Cooperative Thoracic Oncoloy Project (ECTOP) . The primary objective of the study is to assess the 5-year overall survival of patients with one or two ground-glass opacities by employing an active surveillance approach rather than… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Ground-glass Opacities, Active Surveillance
- What is being tested?
- Active surveillance
- Type of treatment
- Surgery or procedure
- How many people
- 387 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 May 2038
- How long will I take part?
- 10 Years
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients visiting the hospitals/medical centers.
Patients eligible for enrollment in the study are required to meet all the following criteria.
- Demonstrates the following on thin-section computed tomography (TSCT) scan:
- Presence of one or two GGNs (bilateral lesions are permitted).
- All lesions have remained stable without regression or enlargement for at least 3 months.
- The dominant lesion (the lesion with the largest maximum tumor diameter) has a maximum tumor diameter ≥0.6cm and ≤2cm.
- CTR ≤0.25 in lesions.
- No lymph node with a diameter >1cm in the mediastinal view.
- Not adjacent to the pleura in dominant lesion and no sign of pleural retraction in any lesions.
- Has not previously undergo any anti-tumor drug or radiation therapy for the lung lesions.
- Aged 18-75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Written informed consent.
Patients will be excluded if they meet any of the following criteria.
- History of any prior malignancies within the past 5 years.
- History of lung surgery.
- History of interstitial pneumonia, pulmonary fibrosis or other severe pulmonary diseases.
- Presence of severe or uncontrolled diseases that may possibly reduce the 10-year life expectancy.
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
Fudan University Shanghai Cancer Center
Shanghai
Haoxuan Wu, 86-64175590 ext. 63189, haoxuanwu@hotmail.com
About this study
Official title: Active Surveillance for Patients with Limited Ground-glass Nodules in China: a Prospective Multi-center Single-arm Trial (ECTOP-1028)
This study is a single-arm, multi-center, phase III trial conducted under the Eastern Cooperative Thoracic Oncoloy Project (ECTOP) . The primary objective of the study is to assess the 5-year overall survival of patients with one or two ground-glass opacities by employing an active surveillance approach rather than immediate surgical resection.
Read the detailed description
The trial aims to confirm the hypotheses that delaying surgery until GGO nodules exhibit progression or meet certain criteria offers a prognosis equivalent to those undergoing immediate surgical resection, potentially allowing many of these patients to avoid surgery altogether.
- Conditions
- Lung Ground-glass Opacities, Active Surveillance
- Being tested
- Active surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active surveillanceProcedure or surgery
Conduct thoracic computed tomography scans every 12 months. If progression occurs, the treamtent approach would involve surgery.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Active surveillance Receives: Procedure: Active surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year overall survival
The event is defined as the death due to any causes.
Measured: 5 years
Secondary outcomes (1)
10-year overall survival
The event is defined as the death due to any causes.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 May 2025 (estimated)
- Primary completion1 May 2038 (estimated)
- Study completion1 May 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Ground-glass OpacitiesStudies 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
- 387 participants (estimated)
- Target duration
- 10 Years
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
- NCT06394037
- Sponsor's protocol ID
- ECTOP-1028
- Status last verified
- Sep 2024
- First submitted
- 27 Apr 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The clinical data including patient characteristics, CT images and pathology images.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance for Patients with Limited Ground-glass Nodules in China: a Prospective Multi-center Single-arm Trial (ECTOP-1028)
- ClinicalTrials.gov ID
- NCT06394037
- Acronym / sponsor ID
- ECTOP-1028
- Conditions
- Lung Ground-glass Opacities, Active Surveillance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 387 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2038 (estimated)
- Study completion
- 1 May 2038 (estimated)
- First posted
- 1 May 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.
This study is a single-arm, multi-center, phase III trial conducted under the Eastern Cooperative Thoracic Oncoloy Project (ECTOP) . The primary objective of the study is to assess the 5-year overall survival of patients with one or two ground-glass opacities by employing an active surveillance approach rather than immediate surgical resection.
Detailed description
The trial aims to confirm the hypotheses that delaying surgery until GGO nodules exhibit progression or meet certain criteria offers a prognosis equivalent to those undergoing immediate surgical resection, potentially allowing many of these patients to avoid surgery altogether.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Procedure: Active surveillanceActive surveillance |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients visiting the hospitals/medical centers.
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 |
|---|---|---|
| Active surveillanceConduct thoracic computed tomography scans every 12 months. If progression occurs, the treamtent approach would involve surgery. | Procedure or surgery | Observation |
Primary outcome
5-year overall survival
Time frame: 5 years
The event is defined as the death due to any causes.
1 secondary outcome
10-year overall survival
Time frame: 10 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 31 Jan 2025.
- Individual participant dataSharing planned: Yes. The clinical data including patient characteristics, CT images and pathology images.
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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 Ground-glass Opacities and Active Surveillance, 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?
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 31 Jan 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year overall survival (time frame: 5 years). 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 31 Jan 2025.