The Clinical Study of Modern Therapies on Flora in Body Fluids and Blood of Malignant Tumor Patients

Study Overview
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Brief Summary
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The clinical study of modern therapies on flora changing in blood, oral cavity, urethra and intestinal tract of patients with malignant tumors. The study is observational. Patients are diagnosed cancer based on pathology or cell biology. The sample of flora will be obtained from their blood, oral cavity, urethra and intestinal tract, mainly to study what modern therapies lead to the influence of microecological environment including diversity and abundance of bacteria in patients who received malignant tumors. Immunological examination and Blood biochemistry evaluation include the number ratio, activity and function of immune cell, the immune cell marker(CD3, CD4, CD8, etc), C-reactive protein(CRP), tumor necrosis factor(TNF), Inflammatory stimulant factor(IL-2, IL-6, etc), tumor marker(CEA, AFP, etc),etc. Clinical evaluation includes image data(CT/MRI), quality of life(QOL), no disease progression survival, total survival, objective disease remission rate, etc.

Detailed Description
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This study collected samples of feces, urine, discarded blood and pharyngeal swab specimens from clinical laboratory from patients with malignant tumors in thoracic surgery department, general surgery department, oncology department and etc before and after treatments which contain chemotherapy, radiation therapy, immune targeted, endocrine therapy, surgery, traditional Chinese medicine and other modern therapies. Researchers will analyze the samples by oral flora, urethra, blood flora bacteria, the species diversity and abundance of the intestinal flora. Besides, quantitative analysis of inflammatory stimulators, c-reactive protein and tumor necrosis factor in peripheral blood was conducted to observe the relationship between the change characteristics of blood, oral, intestinal, urinary tract flora and urine composition caused by treatment and the therapeutic effect and prognosis.

Official Title
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The Clinical Study of Modern Therapies on Flora in Body Fluids and Blood of Malignant Tumor Patients

Conditions
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Lung Cancer, Breast Cancer, Gastrointestinal Cancer, Malignant Neoplasms

Intervention / Treatment
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* Diagnostic Test: Flora analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-85 years old, male or female Clinical diagnosis of malignant tumors It is planned to receive cancer treatment The genre of therapies is not limited, which contain chemotherapy, radiation therapy, immune targeted, endocrine therapy, surgery, traditional Chinese medicine and other modern therapies Exclusion Criteria: Cancer treatment before therapies Previous history: He has suffered from intestinal microecology-related diseases such as cirrhosis, ulcerative colitis, Crohn's disease, irritable bowel syndrome, and urinary system diseases Neurological, psychiatric or unconscious disorders. The following drugs were used within 2 weeks before enrollment: Probiotic preparations, various prebiotic preparations, etc gastrointestinal peristaltic drug; Take drugs known to have a significant effect on the intestinal and urethral flora within half a year (such as proton pump inhibitors, purgatives, bismuth, adsorbents, non-steroidal anti-inflammatory drugs, etc.) Other situations that the researcher considers unsuitable to participate in the experiment;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Flora analysis|diversity and abundance of bacteria in patients who received malignant tumors|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of diversity of intestinal flora in faeces during therapy |  | the 1st day before the start of each kind of therapies, through cancer treatment, day 1, day 3, day 7 after treatment completion, 6 months | 
| The change of diversity of urethral flora in urine during therapy |  | the 1st day before the start of each kind of therapies, through cancer treatment, day 1, day 3, day 7 after treatment completion, 6 months | 
| The change of diversity of oral flora in pharyngeal swab during therapy |  | the 1st day before the start of each kind of therapies, through cancer treatment, day 1, day 3, day 7 after treatment completion, 6 months | 
| The change of diversity of flora in blood during therapy |  | the 1st day before the start of each kind of therapies, through cancer treatment, day 1, day 3, day 7 after treatment completion, 6 months | 
| The change of abundance of intestinal flora in faeces during therapy |  | the 1st day before the start of each kind of therapies, through cancer treatment, day 1, day 3, day 7 after treatment completion, 6 months | 
| The change of abundance of urethral flora in urine during therapy |  | the 1st day before the start of each kind of therapies, through cancer treatment, day 1, day 3, day 7 after treatment completion, 6 months | 
| The change of abundance of oral flora in pharyngeal swab in urine during therapy |  | the 1st day before the start of each kind of therapies, through cancer treatment, day 1, day 3, day 7 after treatment completion, 6 months | 
| The change of abundance of flora in blood during therapy |  | the 1st day before the start of each kind of therapies, through cancer treatment, day 1, day 3, day 7 after treatment completion, 6 months | 
| The change of concentration of purine metabolites in urine during therapy |  | the 1st day before the start of each kind of therapies, through cancer treatment, day 1, day 3, day 7 after treatment completion, 6 months | 
| The change of concentration of P-hydroxyphenylalanine metabolites in urine |  | the 1st day before the start of each kind of therapies, through cancer treatment, day 1, day 3, day 7 after treatment completion, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of the number of tumor necrosis factor(TNF)-α in blood during the therapy |  | the 1st day before the start of each kind of therapies, through cancer treatment, day 1, day 3, day 7 after treatment completion, 6 months | 
| The change of the number of immune cell marker(CD3, CD4, CD8, etc) in blood during the therapy |  | the 1st day before the start of each kind of therapies, through cancer treatment, day 1, day 3, day 7 after treatment completion, 6 months | 
| The change of the number of C-reactive protein(CRP) in blood during the therapy |  | the 1st day before the start of each kind of therapies, through cancer treatment, day 1, day 3, day 7 after treatment completion, 6 months | 
| The change of the number of tumor marker(CEA, AFP, etc) in blood during the therapy |  | the 1st day before the start of each kind of therapies, through cancer treatment, day 1, day 3, day 7 after treatment completion, 6 months | 
| The change of the number of Gastrin in blood during the therapy |  | the 1st day before the start of each kind of therapies, through cancer treatment, day 1, day 3, day 7 after treatment completion, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flora