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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04202848
• Other study ID #: PJ-KS-KY-2019-134
• Status: Not yet recruiting
• Start date: December 20, 2019
• Est. completion date: November 11, 2022

Study information

• Verified date: December 2019
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: Xiaonan Cui, MD, PHD
• Phone: +8618098876725
• Email: cxn23[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: November 11, 2022
• Est. primary completion date: November 11, 2022
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• Breast Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Lung Cancer
• Malignant Neoplasms
• Neoplasms

Intervention

Diagnostic Test:
• Flora analysis
diversity and abundance of bacteria in patients who received malignant tumors

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	The change of the number of tumor necrosis factor(TNF)-a 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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