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

December 15, 2019 updated by: The First Affiliated Hospital of Dalian Medical University
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Xiaonan Cui, MD, PhD
  • Phone Number: +8618098876725
  • Email: cxn23@sina.com

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • The First Affiliated Hospital of Dalian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The change of diversity of intestinal flora in faeces during therapy
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The change of the number of tumor necrosis factor(TNF)-α in blood during the therapy
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital of Dalian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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