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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced NSCLC patients receiving first-line ICIs | For stage IIIB-IV patients with NSCLC who have received immune checkpoint inhibitors as first-line therapy. |
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| Limited-stage and extensive-stage SCLC patients receiving first-line ICIs | For limited-stage and extensive-stage SCLC patients who have received immune checkpoint inhibitors as first-line therapy. |
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| NSCLC patients receiving neoadjuvant therapy of ICIs | For stage IB-IIIB patients with non-small cell lung cancer who have received neoadjuvant therapy of immune checkpoint inhibitors. |
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| Early stage NSCLC patients receiving radical resection | For early-stage patients with non-small cell lung cancer who have received radical resection. |
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| Advanced NSCLC patients receiving first-line targeted therapy | For stage IIIB-IV patients with NSCLC who have received targeted agents as first-line therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure: sleep disturbance status | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1 & 5: Progression-free survival (PFS) | Time from the beginning of first-line immunotherapy or targeted therapy to the first progression (PD). | 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. | 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. | 3 years |
| Cohort 4: Disease-free survival (DFS) | Duration between the date after surgery to the date of any recurrence or death firstly. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 2: Progression-free survival (PFS) | Time from the beginning of first-line immunotherapy to the first progression (PD). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota signature | The baseline fetal is collected and assessed by 16S rRNA sequencing to explore the association between gut microbiota, states of sleep disturbance and efficacy and prognosis. | 5 years |
| Tumor microenvironment signature |
Cohort 1:
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Cohort 2:
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Cohort 3:
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Cohort 4:
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Cohort 5:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Wu, MD. PhD | Contact | +86 13574858332 | wufang4461@csu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, The Second Xiangya Hospital, Central South University | Recruiting | Changsha | Hunan | 410011 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D020447 | Parasomnias |
| D016609 | Neoplasms, Second Primary |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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baseline tumor tissue, serial blood and stool samples (baseline and treatment follow-up time points).
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| 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. | 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) | 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. | 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. | 3 years |
The baseline paraffin-embedded tissue is collected and assessed by multiplex immunohistochemistry, single-cell sequencing, and spatial transcriptome sequencing to explore the association between tumor microenvironment signature, states of sleep disturbance and efficacy and prognosis.
| 5 years |
| Peripheral blood biomarker and immune cells signature | The baseline peripheral venous blood is collected. Sleep-related biomarkers (including melatonin, epinephrine, norepinephrine, cortisol, serotonin, dopamine, and endorphins) are measured. The peripheral immune cells signature is assessed by flow cytometry, including T lymphocytes, B lymphocytes, NK lymphocytes, macrophagocyte, and dendritic cells (DCs). And explore the associations between peripheral blood biomarkers, immune cells signature, states of sleep disturbance and efficacy and prognosis. | 5 years |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |