NCT06975384Toboroz
The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. máj. 16. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 1270 (tervezett)
- Első benyújtás
- 2025. máj. 9.
- Kezdés
- 2024. nov. 1.
- Elsődleges befejezés
- 2029. dec. 31.
- Fő szponzor
- Second Xiangya Hospital of Central South University
- Betegségek
- Tüdőrák
- NCT-szám
- NCT06975384
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 1270
- 2024. nov. 1. és az elsődleges befejezés (2029. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Concurrent acute or chronic psychiatric disorders;
- Patients receiving sleep medication;
- Prior participation in other clinical drug trials;
- Concurrent acute or chronic psychiatric disorders;
- Patients receiving sleep medication;
- Prior participation in other clinical drug trials;
- Concurrent acute or chronic psychiatric disorders;
- Patients receiving sleep medication;
- Prior participation in other clinical drug trials;
- Concurrent acute or chronic psychiatric disorders;
- Patients receiving sleep medication;
- Prior participation in other clinical drug trials;
- Concurrent acute or chronic psychiatric disorders;
- Patients receiving sleep medication;
- Prior participation in other clinical drug trials;
Más betegség
- Presence of other malignant tumors or malignant diseases within 3 years;
- Presence of other malignant tumors or malignant diseases within 3 years;
- Presence of other malignant tumors or malignant diseases within 3 years;
- Presence of other malignant tumors or malignant diseases within 3 years;
- Presence of other malignant tumors or malignant diseases within 3 years;
Laborértékek
- Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) fusion and/or ROS proto-oncogene 1 (ROS1) fusion-positive;
- EGFR-sensitizing mutation and/or ALK fusion and/or ROS1 fusion-positive;
Egyéb
- Symptomatic brain metastasis;
- Inability to complete scale assessments.
- Cohort 2:
- Symptomatic brain metastasis;
- Inability to complete scale assessments.
- Cohort 3:
- Symptomatic brain metastasis;
- Inability to complete scale assessments.
- Cohort 4:
- Inability to complete scale assessments.
- Cohort 5:
- Symptomatic brain metastasis;
- Inability to complete scale assessments.
Kiket keres a vizsgálat
- 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;
- 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;
- 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.
- 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;
- 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.
A regiszterben nem jelölt feltételek
- Cohort 1:
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Department of Oncology, The Second Xiangya Hospital, Central South University Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Changsha | Kína | Toboroz |
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