A Registry for People With Lung Cancer
Pulmonary Segmentectomy for Lung Cancer: A Real-World International Registry-TSOG 108
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: David Jones, MD
- Phone Number: 212-639-6428
- Email: jonesd2@mskcc.org
Study Contact Backup
- Name: Bernard Park, MD
- Phone Number: 646-888-3346
- Email: parkb@mskcc.org
Study Locations
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Ontario
-
Toronto, Ontario, Canada, M5G 2C4
- Recruiting
- University Health Network (Data Collection Only)
-
Contact:
- Elliot Wakeam, MD
- Email: elliot.wakeam@uhn.ca
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Quebec
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Montreal, Quebec, Canada, H2L 4M1
- Recruiting
- Centre Hospitalier de l'Université de Montreal (Data Collection Only)
-
Contact:
- Moishe Liberman, MD. PhD
- Phone Number: 514-890-8000, ext: 26832
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-
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Arizona
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Tucson, Arizona, United States, 85704
- Recruiting
- University of Arizona (Data Collection Only)
-
Contact:
- Praveen Sridhar, MD
- Phone Number: 520-694-2873
- Email: psridhar@arizona.edu
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-
California
-
San Diego, California, United States, 92103
- Recruiting
- University of California San Diego (Data collection)
-
Contact:
- Joshua Boys, MD
- Phone Number: 858-657-7777
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Illinois
-
Chicago, Illinois, United States, 606012
- Recruiting
- Rush University Medical Center (Data collection only)
-
Contact:
- Christopher Seder, MD
- Phone Number: 312-738-3732
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Evanston, Illinois, United States, 60201
- Recruiting
- Endeavor Health
-
Contact:
- Seth Krantz, MD
- Phone Number: 847-570-2868
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan (Data Collection Only)
-
Contact:
- Jules Lin, MD
- Phone Number: 734-936-8857
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New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Recruiting
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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Contact:
- David Jones, MD
- Phone Number: 212-639-6428
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Middletown, New Jersey, United States, 07748
- Recruiting
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
-
Contact:
- David Jones, MD
- Phone Number: 212-639-6428
-
Montvale, New Jersey, United States, 07645
- Recruiting
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
-
Contact:
- David Jones, MD
- Phone Number: 212-639-6428
-
-
New York
-
Commack, New York, United States, 11725
- Recruiting
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
-
Contact:
- David Jones, MD
- Phone Number: 212-639-6428
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Harrison, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester (Limited protocol activities)
-
Contact:
- David Jones, MD
- Phone Number: 212-639-6428
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New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center (All protocol activities)
-
Contact:
- Yuan Liu, MD, PhD
- Phone Number: 646-888-3640
-
Contact:
- David Jones, MD
- Phone Number: 212-639-6428
-
Principal Investigator:
- David Jones, PhD
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Uniondale, New York, United States, 11553
- Recruiting
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
-
Contact:
- David Jones, MD
- Phone Number: 212-639-6428
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Thomas Jefferson University Hospital (Data Collection Only)
-
Contact:
- Nathaniel Evans III, MD
- Email: nathaniel.evans@jefferson.edu
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Pittsburgh, Pennsylvania, United States, 15212
- Recruiting
- ALLEGHENY HEALTH NETWORK (Data Collection Only)
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Contact:
- Benny Weksler, MD
- Phone Number: 412-359-6137
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Texas
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Dallas, Texas, United States, 75246
- Recruiting
- Baylor University Medical Center (Data Collection Only)
-
Contact:
- Shanda Blackmon, MD, MPH
- Phone Number: 713-198-6376
- Email: sshanda.blackmon@bcm.edu
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Houston, Texas, United States, 77030
- Recruiting
- MD ANDERSON CANCER CENTER (Data Collection Only)
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Contact:
- David Rice, MD
- Phone Number: 800-392-1611
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years
- Patients suitable for segmentectomy, according to the treating surgeon
- 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:
- Actively receiving lung cancer treatment or a history of lung cancer in the previous 5 years
- 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.
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Participants with Lung Cancer
Participants undergoing planned pulmonary segmentectomy for primary lung cancer
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determine 3-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer.
Time Frame: 3 years
|
DFS is measured from the date of surgery to the date of recurrence or death
|
3 years
|
|
Determine 5-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer.
Time Frame: 5 years
|
DFS is measured from the date of surgery to the date of recurrence or death
|
5 years
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: David Jones, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 24-127
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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