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

NCT ID: NCT04202848

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-20

Study Completion Date

2022-11-11

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.

Conditions

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Lung Cancer Breast Cancer Gastrointestinal Cancer Malignant Neoplasms

Keywords

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Flora

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Flora analysis

diversity and abundance of bacteria in patients who received malignant tumors

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status

Countries

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China

Central Contacts

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Xiaonan Cui, MD, PHD

Role: CONTACT

Phone: +8618098876725

Email: [email protected]

Yuwei Ma, MM

Role: CONTACT

Phone: +8618742567906

Email: [email protected]

Facility Contacts

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Xiaonan Cu, MD,PhD

Role: primary

Yuwei Ma, MM

Role: backup

Other Identifiers

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PJ-KS-KY-2019-134

Identifier Type: -

Identifier Source: org_study_id