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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

Következő lépések

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

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Department of Oncology, The Second Xiangya Hospital, Central South UniversityChangshaKínaToboroz

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