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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Lung Cancer; Gastrointestinal Cancer; Malignant Neoplasms
• Intervention / Treatment: Diagnostic test: Flora analysis

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Xiaonan Cui, MD, PhD; Phone Number: +8618098876725; Email: cxn23@sina.com
• Study Contact Backup: Name: Yuwei Ma, MM; Phone Number: +8618742567906; Email: 2932166904@qq.com

Study Locations

• China
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • The First Affiliated Hospital of Dalian Medical University
      • Contact: Xiaonan Cu, MD,PhD; Phone Number: +8618098876725; Email: cxn23@sina.com
      • Contact: Yuwei Ma, MM; Phone Number: +8618742567906; Email: 2932166904@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with malignant tumors

Description

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;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Dalian Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 20, 2019
• Primary Completion (Anticipated): November 11, 2022
• Study Completion (Anticipated): November 11, 2022

Study Registration Dates

• First Submitted: December 8, 2019
• First Submitted That Met QC Criteria: December 15, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 15, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Flora
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Neoplasms; Gastrointestinal Neoplasms
• Other Study ID Numbers: PJ-KS-KY-2019-134

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No