Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2024-05-15
2029-05-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with Lung Cancer
Participants undergoing planned pulmonary segmentectomy for primary lung cancer
Patient-Reported Outcomes Measurement Information System
Participants-reported outcomes will be collected using the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS is a web-based platform developed by the National Institutes of Health. Scoring is standardized on a scale from 0 to 100, with a population mean of 50 and standard deviation of 10 units. High scores mean more of the concept being measured. This study will use PROMIS surveys assessing three domains: physical function (PROMIS bank version 2.0), pain interference (PROMIS bank version 1.1), and dyspnea severity (PROMIS bank version 1.0)
Interventions
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Patient-Reported Outcomes Measurement Information System
Participants-reported outcomes will be collected using the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS is a web-based platform developed by the National Institutes of Health. Scoring is standardized on a scale from 0 to 100, with a population mean of 50 and standard deviation of 10 units. High scores mean more of the concept being measured. This study will use PROMIS surveys assessing three domains: physical function (PROMIS bank version 2.0), pain interference (PROMIS bank version 1.1), and dyspnea severity (PROMIS bank version 1.0)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical Stage I with suspected NSCLC, classified preoperatively based on the AJCC TNM staging manual, 9th edition o Note: Tissue diagnosis of NSCLC is not required before enrollment. A pathologic diagnosis of NSCLC may be confirmed preoperatively with biopsy, intraoperatively with frozen section, or postoperatively on final pathology
Exclusion Criteria
* History of chemotherapy or radiation therapy for a previous lung cancer
* Synchronous secondary cancer in the lung or elsewhere in the body at the time of surgery
* Carcinoid tumors
* History of other malignancies within the past 3 years, with the exception of non-melanoma skin cancer, superficial bladder cancer, and carcinoma in situ of the cervix
* Actively receiving treatment for other malignancies
* Cases of lobectomy in conjunction with segmentectomy from another lobe and ≥2 segmentectomies from different lobes either en bloc or separate will be excluded from the primary analysis.
* Multi-segmental resection from the same lobe is not a criterion for exclusion.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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David Jones, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Rush University Medical Center (Data collection only)
Chicago, Illinois, United States
Endeavor Health
Evanston, Illinois, United States
University of Michigan (Data Collection Only)
Ann Arbor, Michigan, United States
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
ALLEGHENY HEALTH NETWORK (Data Collection Only)
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center (Data Collection Only)
Houston, Texas, United States
University Health Network (Data Collection Only)
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montreal (Data Collection Only)
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Christopher Seder, MD
Role: primary
Seth Krantz, MD
Role: primary
Jules Lin, MD
Role: primary
David Jones, MD
Role: primary
David Jones, MD
Role: primary
David Jones, MD
Role: primary
David Jones, MD
Role: primary
David Jones, MD
Role: primary
David Jones, MD
Role: primary
Yuan Liu, MD, PhD
Role: backup
David Jones, MD
Role: primary
Benny Weksler, MD
Role: primary
David Rice, MD
Role: primary
Elliot Wakeam, MD
Role: primary
Moishe Liberman, MD. PhD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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24-127
Identifier Type: -
Identifier Source: org_study_id