This is the prospective, observational cohort study (Nezha) to explore the associations of sleep disturbance with progression, efficacy of immune checkpoint inhibitors (ICIs) and prognosis of Lung Cancer. The participants including the patients diagnosed with advanced non-small-cell lung cancer (NSCLC) who received either first-line therapy (ICIs or targeted agents) or neoadjuvant therapy with ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early non-small-cell lung cancer (NSCLC) receiving surgery.
This is the prospective, observational cohort study (Nezha) to explore the associations of sleep disturbance with progression, efficacy of ICIs and prognosis of Lung Cancer. This study will have 5 cohorts * Cohort 1: A prospective, observational cohort study to explore the association between sleep disturbance and the efficacy of first-line treatment of ICIs in advanced NSCLC. * Cohort 2: A prospective, observational cohort study to explore the association between sleep disturbance and the efficacy of first-line treatment of limited-stage and extensive-stage SCLC. * Cohort 3: A prospective, observational cohort study to explore the association between sleep disturbance and the efficacy of neoadjuvant therapy of ICIs in resectable NSCLC. * Cohort 4: A prospective, observational cohort study to explore the association of sleep disturbance with postoperative recurrence and prognosis in early-stage NSCLC receiving radical surgery. * Cohort 5: A prospective observational cohort study to explore the association between sleep disturbance and the efficacy of first-line treatment of targeted therapy in advanced NSCLC.
Study Type
OBSERVATIONAL
Enrollment
1,270
The assessment of sleep disturbance was conducted using Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI). Patients with a PSQI score \> 5 or an ISI score \> 7 were categorized as sleep disturbance patients. The assessment of chronotype was conducted using reduced Morningness-Eveningness Questionnaire (rMEQ). Patients with an rMEQ score 18-25 were categorized as the morning type, those with an rMEQ score 12-17 as the intermediate type, and those with an rMEQ score 4-11 as the evening type.
Department of Oncology, The Second Xiangya Hospital, Central South University
Changsha, Hunan, China
RECRUITINGCohort 1 & 5: Progression-free survival (PFS)
Time from the beginning of first-line immunotherapy or targeted therapy to the first progression (PD).
Time frame: 3 years
Cohort 2: Overall survival (OS)
Duration from the beginning of first-line immunotherapy until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.
Time frame: 5 years
Cohort 3: Event-free survival (EFS)
Time from the start of initial treatment of immunotherapy to the occurrence of any event, including disease progression, discontinuation of treatment for any reason, or death.
Time frame: 3 years
Cohort 4: Disease-free survival (DFS)
Duration between the date after surgery to the date of any recurrence or death firstly.
Time frame: 5 years
Cohort 2: Progression-free survival (PFS)
Time from the beginning of first-line immunotherapy to the first progression (PD).
Time frame: 3 years
Cohort 1 & 3 & 4 & 5: Overall survival (OS)
Overall Survival (OS) is defined as the duration from the start of initial treatment (systemic treatment or radical therapy) until death from any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.
Time frame: 5 years
Quality of life (QoL)
Quality of life (QoL) is assessed longitude by EORTC QLQ-C30 (version.3). The EORTC QLQ-C30 is composed of 9 multi-item scales: 5 functioning scales (physical, role, cognitive, emotional, and social), a global QOL scale, and 3 symptom scales (fatigue, pain, and nausea/vomiting). All scales and single items are linearly transformed to an 0-100 scale. A higher score represents a better level of functioning.
Time frame: 5 years
Cohort 1 & 2 & 5: Objective Response Rate (ORR)
The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: 2 years
Cohort 3: Pathologic complete response (pCR) rate
pCR is no viable tumor cells in tumor bed and lymph nodes. The pCR rate is the proportion of patients with a pathologic complete response.
Time frame: 3 years
Cohort 3: Major pathologic response (MPR)
MPR refers to the percentage of surviving tumor cells in the tumor bed after neoadjuvant therapy ≤10%, regardless of whether there are surviving tumor cells in the lymph nodes.
Time frame: 3 years
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