Идёт набор NCT06975384

The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer

— Наблюдательное Lung Cancer Sleep Disturbance Immune Checkpoint Inhibitors Cancer, Treatment-Related

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Exposure: sleep disturbance status.
Кому может быть актуально: Состояния в реестре: Lung Cancer, Sleep Disturbance, Immune Checkpoint Inhibitors, Cancer, Treatment-Related. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer, Including Non-small-cell Lung Cancer and Small-cell Lung Cancer With Early and Advanced Staging

Обзор

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.

Подробное описание

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.

Вмешательства

Другое Exposure: sleep disturbance status
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

Первичные конечные точки

Cohort 1 & 5: Progression-free survival (PFS) [Срок оценки: 3 years]
Cohort 2: Overall survival (OS) [Срок оценки: 5 years]
Cohort 3: Event-free survival (EFS) [Срок оценки: 3 years]
Cohort 4: Disease-free survival (DFS) [Срок оценки: 5 years]

Вторичные конечные точки (6)

Cohort 2: Progression-free survival (PFS) [Срок оценки: 3 years]
Cohort 1 & 3 & 4 & 5: Overall survival (OS) [Срок оценки: 5 years]
Quality of life (QoL) [Срок оценки: 5 years]
Cohort 1 & 2 & 5: Objective Response Rate (ORR) [Срок оценки: 2 years]
Cohort 3: Pathologic complete response (pCR) rate [Срок оценки: 3 years]
Cohort 3: Major pathologic response (MPR) [Срок оценки: 3 years]

Критерии участия

Cohort 1:

Критерии включения

Age ≥ 18 years old;
Histologically confirmed diagnosis of NSCLC;
Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1;
Treatment naïve;
Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1);
Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
Informed consent to participate in the study;

Критерии исключения

Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) fusion and/or ROS proto-oncogene 1 (ROS1) fusion-positive;
Presence of other malignant tumors or malignant diseases within 3 years;
Concurrent acute or chronic psychiatric disorders;
Patients receiving sleep medication;
Prior participation in other clinical drug trials;
Symptomatic brain metastasis;
Inability to complete scale assessments.

Cohort 2:

Критерии включения

Age ≥ 18 years old;
Histologically confirmed diagnosis of SCLC；
Unresectable locally advanced, metastatic, or recurrent stage Ⅲ-Ⅳ based on AJCC TNM staging 8th edition;
ECOG PS of 0-1;
Treatment naïve;
Presence of at least one measurable lesion according to the RECIST v1.1 ;
Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
Informed consent to participate in the study;

Критерии исключения

Presence of other malignant tumors or malignant diseases within 3 years;
Concurrent acute or chronic psychiatric disorders;
Patients receiving sleep medication;
Prior participation in other clinical drug trials;
Symptomatic brain metastasis;
Inability to complete scale assessments.

Cohort 3:

Критерии включения

Age ≥18 years old;
Pathologically diagnosed as NSCLC;
Resectable clinical stage IB-IIIB based on AJCC TNM staging 8th edition;
At least one measurable lesion can be evaluated according to the RECIST v1.1;
Treatment naïve;
Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy as neoadjuvant therapy;
Cardiopulmonary function can withstand surgery;
Informed consent to participate in the study.

Критерии исключения

EGFR-sensitizing mutation and/or ALK fusion and/or ROS1 fusion-positive;
Presence of other malignant tumors or malignant diseases within 3 years;
Concurrent acute or chronic psychiatric disorders;
Patients receiving sleep medication;
Prior participation in other clinical drug trials;
Symptomatic brain metastasis;
Inability to complete scale assessments.

Cohort 4:

Критерии включения

Age ≥ 18 years old;
Pathologically diagnosed as NSCLC;
Pathologically stage confirmed as early stage of IA-IIIA;
Available for tumor tissue samples;
Treatment naïve;
Receiving radical surgery;
Informed consent to participate in the study;

Критерии исключения

Presence of other malignant tumors or malignant diseases within 3 years;
Concurrent acute or chronic psychiatric disorders;
Patients receiving sleep medication;
Prior participation in other clinical drug trials;
Inability to complete scale assessments.

Cohort 5:

Критерии включения

Age ≥ 18 years old;
Histologically confirmed diagnosis of NSCLC;
Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;
ECOG PS of 0-1;
Treatment naive;
Presence of at least one measurable lesion according to the RECIST v1.1;
Receiving targeted therapy or combination with chemotherapy;
Informed consent to participate in the study;
Driver gene-positive.