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This is the prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC) and non-small-cell lung cancer (NSCLC).
This is the prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC) and Non-Small-Cell Lung Cancer (NSCLC). Eligible patients were administered first-line treatment with either immune checkpoint inhibitor or a combination of immunotherapy and chemotherapy upon enrollment. This study will have 2 cohorts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Treatment-naïve, advanced and inoperable GEC patients receiving first-line ICIs | For treatment-naïve, advanced and inoperable Esophageal Cancer or Gastric Cancer or Gastroesophageal junction (GEJ) Cancer patients who have received immune checkpoint inhibitors as first-line therapy. |
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| Cohort 2: Treatment-naïve, advanced and inoperable NSCLC patients receiving first-line ICIs. | For treatment-naïve, advanced and inoperable Non-Small-Cell Lung Cancer patients who have received immune checkpoint inhibitors as first-line therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure: emotional distress status | Other | The assessment of depressive and anxiety symptoms was conducted using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment 7 (GAD-7). Patients with a sum score of PHQ-9 and GAD-7 ≥ 10 were categorized as the stressed group. |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1 & 2: Progression-free survival (PFS) | Time from the beginning of first-line immunotherapy to the first progression (PD) or death in patients | 4 year |
| Measure | Description | Time Frame |
|---|---|---|
| Value of Neutrophils to lymphocytes ratio (NLR) | NLR is an inflammatory marker, which is the ratio of neutrophils to lymphocytes. The higher the value is, the higher the inflammatory level may be. The information has been extracted from the medical record and evaluated longitudinally. | 0 day, 6 weeks |
| Value of Platelet-lymphocyte ratio (PLR) |
| Measure | Description | Time Frame |
|---|---|---|
| Prognostic models for immunotherapy | Tumor biomarkers, such as CEA, CA19-9, CA72-4, NSE, SCC, and the above-mentioned metabolic and inflammatory markers in peripheral blood were collected at baseline and after two cycles of treatment (6 weeks). The scores of PHQ-9 and GAD-7 questionnaires were also collected. The variables were screened to establish an optimal prognostic model. | 0 day, 6 weeks |
Cohort 1 & 2
Inclusion Criteria:
Exclusion Criteria:
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Cohort 1 comprises patients diagnosed with treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC), encompassing those with esophageal cancer, gastric cancer, and gastroesophageal junction cancer who are undergoing first-line ICI therapy. Cohort 2 consists of patients with treatment-naïve, advanced and inoperable Non-Small Cell Lung Cancer (NSCLC) receiving first-line ICI therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China |
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PLR is an inflammatory marker, a ratio of platelets to lymphocytes. A higher value of it indicates a higher level of inflammation in the body. The information has been extracted from the medical record and evaluated longitudinally. |
| 0 day, 6 weeks |
| Value of Monocyte-lymphocyte ratio (MLR) | MLR is an inflammatory indicator, which is the ratio of macrophages and lymphocytes. The higher the value is, the higher the inflammatory level in the body is. The information has been extracted from the medical record and evaluated longitudinally. | 0 day, 6 weeks |
| Value of Systemic immune inflammation index (SII) | SII is an inflammatory indicator, which is calculated as follows: SII= (neutrophil × platelet)/lymphocytes. A higher value indicates an elevated level of inflammation within the body. The information has been extracted from the medical record and evaluated longitudinally. | 0 day, 6 weeks |
| Value of Pan-immune inflammation value (PIV) | PIV is an inflammatory indicator, which is equal to neutrophils × monocytes × platelets/lymphocytes. The higher the value is, the higher the inflammatory level in the body is. The information has been extracted from the medical record and evaluated longitudinally. | 0 day, 6 weeks |
| Value of eosinophil fraction | The eosinophil fraction is a potential inflammation and tumor prognostic indicator, which equals the ratio of eosinophil absolute value to the total white blood cell count. The higher the value of this fraction, the better the tumor prognosis may be. The information has been extracted from the medical record and evaluated longitudinally. | 0 day, 6 weeks |
| Value of prognostic nutritional index (PNI) | PNI is a potential inflammation and tumor prognostic indicator, which is equal to albumin level (g/L) + 5 × absolute value of lymphocyte counts. The higher the value of this index, the better the tumor prognosis may be. The information has been extracted from the medical record and evaluated longitudinally. | 0 day, 6 weeks |
| Value of Blood glucose | Blood glucose is an indicator of metabolism in the body. The information has been extracted from the medical record and evaluated longitudinally. | 0 day, 6 weeks |
| Value of Triglycerides | Triglycerides is an indicator of metabolism in the body. The information has been extracted from the medical record and evaluated longitudinally. | 0 day, 6 weeks |
| Value of Total cholesterol | Total cholesterol is an indicator of metabolism in the body. The information has been extracted from the medical record and evaluated longitudinally. | 0 day, 6 weeks |
| Value of Albumin | Albumin is an indicator of metabolism in the body. The information has been extracted from the medical record and evaluated longitudinally. | 0 day, 6 weeks |
| Disease Control Rate (DCR) | DCR refers to the proportion of patients with tumor treated with a certain treatment who have tumor shrinkage or stable disease, and this state can be maintained for a certain period of time, including the proportion of Complete Response (CR), Partial Response (PR) and Stable Disease (SD). | 1 year |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D007249 | Inflammation |
| D016609 | Neoplasms, Second Primary |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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