The Clinical Study of Modern Therapies on Flora in Body Fluids and Blood of Malignant Tumor Patients
Keywords
Abstract
Description
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.
Dates
| Last Verified: | 11/30/2019 |
| First Submitted: | 12/07/2019 |
| Estimated Enrollment Submitted: | 12/14/2019 |
| First Posted: | 12/17/2019 |
| Last Update Submitted: | 12/14/2019 |
| Last Update Posted: | 12/17/2019 |
| Actual Study Start Date: | 12/19/2019 |
| Estimated Primary Completion Date: | 11/10/2022 |
| Estimated Study Completion Date: | 11/10/2022 |
Condition or disease
Intervention/treatment
Diagnostic Test: Flora analysis
Phase
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Probability Sample |
| Accepts Healthy Volunteers | No |
| Criteria | Inclusion Criteria: 1. Age 18-85 years old, male or female 2. Clinical diagnosis of malignant tumors 3. It is planned to receive cancer treatment 4. 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: 1. Cancer treatment before therapies 2. 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 3. Neurological, psychiatric or unconscious disorders. 4. The following drugs were used within 2 weeks before enrollment: 1. Probiotic preparations, various prebiotic preparations, etc 2. gastrointestinal peristaltic drug; 3. 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.) 5. Other situations that the researcher considers unsuitable to participate in the experiment; |
Outcome
Primary Outcome Measures
1. 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]
2. 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]
3. 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]
4. 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]
5. 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]
6. 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]
7. 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]
8. 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]
9. 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]
10. 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
1. 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]
2. 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]
3. 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]
4. 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]
5. 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]
