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

NCT04202848 | Unknown

• 1 other identifier: PJ-KS-KY-2019-134
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Breast Cancer; Gastrointestinal Cancer; Malignant Neoplasms

Keywords

Flora

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (5)

• 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

Interventions

Flora analysis DIAGNOSTIC_TEST

diversity and abundance of bacteria in patients who received malignant tumors

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with malignant tumors

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

feces, urine, pharyngeal swab specimens from patients with malignant tumors and discarded blood from clinical laboratory

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms; Gastrointestinal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Central Study Contacts

Xiaonan Cui, MD, PHD

CONTACT

+8618098876725; cxn23@sina.com

Yuwei Ma, MM

CONTACT

+8618742567906; 2932166904@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: December 18, 2019
• Study Start: December 20, 2019
• Primary Completion: November 11, 2022
• Study Completion: November 11, 2022
• Last Updated: December 18, 2019

Record last verified: 2019-12

Locations

CN (1)