Health TrialsbyHealthPanel

Active Surveillance for Limited GGNs

ConditionsLung Ground-glass OpacitiesActive Surveillance
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

Outpatients visiting the hospitals/medical centers.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Active surveillance

    Procedure/Surgery

    Conduct thoracic computed tomography scans every 12 months. If progression occurs, the treamtent approach would involve surgery.

Treatment groups

387 Participants
are divided into 1 treatment group
Group A: Observation1 intervention

Trial outcomes

Primary outcomes

1

5-year overall survival

The event is defined as the death due to any causes.

Time frame
5 years

Secondary outcomes

1

10-year overall survival

The event is defined as the death due to any causes.

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: