NCT05477979Toboroz
The Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer (STRESS-LUNG)
Cohort Studies of Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer, Including Non-small-cell Lung Cancer and Small-cell Lung Cancer With Early and Advanced Staging (STRESS-LUNG)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. febr. 25. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
This is the prospective, observational cohort study (STRESS-LUNG) to explore the associations of psychological stress 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 the first-line therapy or neoadjuvant therapy of ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early small-cell lung cancer (SCLC) receiving surgery.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 750 (tervezett)
- Első benyújtás
- 2022. júl. 23.
- Kezdés
- 2020. jún. 1.
- Elsődleges befejezés
- 2027. dec. 31.
- Fő szponzor
- Second Xiangya Hospital of Central South University
- Betegségek
- Tüdőrák
- NCT-szám
- NCT05477979
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 750
- 2020. jún. 1. és az elsődleges befejezés (2027. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Concurrent acute or chronic psychiatric disorders;
- Current receiving anti-depressive or anti-anxiety therapy;
- Previous treatment with other clinical drug trials;
- Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
- Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
- Concurrent acute or chronic psychiatric disorders;
- Current receiving anti-depressive or anti-anxiety therapy;
- Previous treatment with other clinical drug trials;
- Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
- Receiving PD-1/PD-L1 inhibitors combined with chemotherapy as neoadjuvant therapy.
- Cardiopulmonary function can withstand surgery; 7. Informed and agreed to participate in the study;
- Concurrent acute or chronic psychiatric disorders;
- Current receiving anti-depressive or anti-anxiety therapy;
- Previous treatment with other clinical drug trials;
- Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
- Receiving radical surgery;
- Concurrent acute or chronic psychiatric disorders;
- Current receiving anti-depressive or anti-anxiety therapy;
- Previous treatment with other clinical drug trials;
Más betegség
- Combined with other malignant tumors in the past 3 years;
- Pathologically diagnosed as small cell lung cancer;
- Combined with other malignant tumors in the past 3 years;
- Pathologically diagnosed as non-small cell lung cancer;
- Combined with other malignant tumors in the past 3 years;
- Pathologically diagnosed as non-small-cell lung cancer;
- Combined with other malignant tumors in the past 3 years;
Laborértékek
- Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) gene and/or ROS proto-oncogene 1 (ROS1) fusion-positive;
- Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) gene and/or ROS proto-oncogene 1 (ROS1) fusion-positive;
Életkor
- Age ≥ 18 years;
- Age ≥18 years ;
- Age ≥18 years;
Egyéb
- Patients with symptomatic brain metastasis;
- Can't cooperate with psychological scale assessment;
- Cohort 2 (STRESS-LUNG-2):
- Unresectable locally advanced, metastatic, or recurrent stage Ⅲ-Ⅳ based on AJCC TNM staging 8th edition;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ;
- Informed and agreed to participate in the study;
- Patients with symptomatic brain metastasis;
- Can't cooperate with psychological scale assessment;
- Cohort 3 (STRESS-LUNG-3):
- Resectable clinical stage IB-IIIB based on AJCC TNM staging 8th edition;
- At least one measurable lesion can be evaluated according to the RECIST 1.1 standard;
- Can't cooperate with psychological scale assessment;
- Cohort 4 (STRESS-LUNG-4):
- Pathologically stage conformed as early stage of IA-IIIA
- Available for tumor tissue samples;
- Informed and agreed to participate in the study;
- Can't cooperate with psychological scale assessment;
Kiket keres a vizsgálat
- Age ≥ 18 years;
- 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 of 0-1;
- Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
- 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 and agreed to participate in the study;
A regiszterben nem jelölt feltételek
- Cohort 1 (STRESS-LUNG-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 | Changsha | Kína | Toboroz |
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