A Registry for People With Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
Participants will complete questionnaires before surgery, between 2 to 4 weeks after surgery, and 6 months after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
All study subjects will be recruited from their respective clinics (i.e., Thoracic Surgery, Pulmonary, Survivorship, etc.) at participating sites. Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team by screening patients' medical records. If eligible, the study will be discussed with each patient.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Patient-Reported Outcomes Measurement Information System
Other interventionParticipants-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)
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: Participants with Lung Cancer1 intervention
Trial outcomes
Primary outcomes
1
Determine 3-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer.
DFS is measured from the date of surgery to the date of recurrence or death
Time frame
3 years2
Determine 5-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer.
DFS is measured from the date of surgery to the date of recurrence or death
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov