Clinical trial NCT03802981: A Registry for Patients With Multifocal Ground Glass Opacities (GGOs)
Official title: Thoracic Surgery Oncology Group (TSOG) Protocol: Registry Trial of Active Surveillance for Multifocal Ground Glass Opacities (GGOs)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Ground Glass Opacities (GGOs)
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
name: Brigham and Women's Hospital
name: Duke University
name: Mayo Clinic
name: Université de Montréal
name: University of Pittsburgh
name: University of Toronto
name: Washington University School of Medicine
First posted: 2019-01-14
Enrollment: 338
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with GGOs or mixed subsolid pulmonary nodules may be recruited from participating Thoracic Oncology Surgical Group (TSOG) sites, in accordance with local institutional practice and referral patterns, and assessed for eligibility based on the criteria listed below.

Brief summary: The purpose of this registry study is to actively monitor people with GGOs and collect information about them, so that investigators can learn more about these lesions and about the risk of developing lung cancer in study participants whose GGOs are being monitored in the active surveillance program.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* Have two or more GGOs on initial CT imaging
* GGOs must be measure ≤3.0 cm and ≥0.6 cm in the greatest dimension
* GGOs must be greater than half ground glass

A biopsy is not necessary for inclusion in the trial. Biopsy of a GGO, even with a diagnosis of adenocarcinoma, does not necessarily preclude enrollment in this surveillance protocol. In other words, patients with a diagnosis of adenocarcinoma are still eligible, at the discretion of the clinician and/or investigator, if they meet the above criteria.

Exclusion Criteria:

* Patients who are actively undergoing lung cancer treatment or have a history of lung cancer, except for cases of completely resected pathologic stage IA nonsmall cell lung cancer (NSCLC). Patients with stage IA NSCLC and multiple GGOs can enroll in this active surveillance protocol after complete resection of the NSCLC and confirmation of stage on final pathologic assessment.
* The presence of any solid lesion ≥0.6 cm suspicious for malignancy.
* Patients who are actively undergoing treatment for other malignancies

Primary outcomes:
measure: lung cancer-specific survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center (Data collection only)
state: California
city: Hartford
country: United States
facility: Hartford Healthcare
state: Connecticut
city: Chicago
country: United States
facility: Rush University Medical Center (Data collection only)
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: George Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute (Data Collection Only)
state: New York
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania (Data Collection Only)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Baylor University Medical Center
state: Texas
city: Hamilton
country: Canada
facility: McMaster University (Data Collection Only)
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montreal
state: Quebec
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: James Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: