NCT05477979Recruiting

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)

Source: ClinicalTrials.gov · Last updated 25 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Observational
Enrollment: 750 (estimated)
First submitted: 23 Jul 2022
Start date: 1 Jun 2020
Primary completion date: 31 Dec 2027
Lead sponsor: Second Xiangya Hospital of Central South University
Diseases: Lung cancer
NCT number: NCT05477979

What you commit to

Study type: Observational
Planned participants: 750
From 1 Jun 2020 to the primary completion date, 31 Dec 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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.
- 6\. 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;

Other illness

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;

Lab values

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;

Age

Age ≥ 18 years；
Age ≥18 years ；
Age ≥18 years;

Other

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;

Who the study is looking for

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;

Criteria the registry did not label

Cohort 1 (STRESS-LUNG-1):

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Department of Oncology, The Second Xiangya Hospital, Central South University Coordinator of this site? Confirm its status	Changsha	China	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.