AzTrials
AzTrials

Lung CancerNCT04202848

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

An observational study of Lung Cancer and Breast Cancer, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Flora analysis
How many people
500 participants
Where
1 siteChina
Study dates
20 Dec 2019to 11 Nov 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Adult, Older adult

Study population: patients with malignant tumors

Who may be able to join

  • 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

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

Xiaonan Cui, MD, PHD contact

+8618098876725

cxn23@sina.com

Yuwei Ma, MM contact

+8618742567906

2932166904@qq.com

China1 site

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

    Xiaonan Cu, MD,PhD, +8618098876725, cxn23@sina.com

    Yuwei Ma, MM, +8618742567906, 2932166904@qq.com

Other trials in China

About this study

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.

Read the 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.

Being tested
Flora analysis
Keywords
Flora
Medical subject headings
Lung Neoplasms, Breast Neoplasms, Gastrointestinal Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flora analysisDiagnostic test

    diversity and abundance of bacteria in patients who received malignant tumors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change of diversity of intestinal flora in faeces during therapy

    Measured: 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

  2. The change of diversity of urethral flora in urine during therapy

    Measured: 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

  3. The change of diversity of oral flora in pharyngeal swab during therapy

    Measured: 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

  4. The change of diversity of flora in blood during therapy

    Measured: 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

  5. The change of abundance of intestinal flora in faeces during therapy

    Measured: 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

  6. The change of abundance of urethral flora in urine during therapy

    Measured: 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

  7. The change of abundance of oral flora in pharyngeal swab in urine during therapy

    Measured: 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

  8. The change of abundance of flora in blood during therapy

    Measured: 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

  9. The change of concentration of purine metabolites in urine during therapy

    Measured: 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

  10. The change of concentration of P-hydroxyphenylalanine metabolites in urine

    Measured: 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)

  1. The change of the number of tumor necrosis factor(TNF)-α in blood during the therapy

    Measured: 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

  2. The change of the number of immune cell marker(CD3, CD4, CD8, etc) in blood during the therapy

    Measured: 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

  3. The change of the number of C-reactive protein(CRP) in blood during the therapy

    Measured: 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

  4. The change of the number of tumor marker(CEA, AFP, etc) in blood during the therapy

    Measured: 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

  5. The change of the number of Gastrin in blood during the therapy

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2019
  2. Study start20 Dec 2019 (estimated)
  3. Primary completion11 Nov 2022 (estimated)
  4. Study completion11 Nov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04202848
Sponsor's protocol ID
PJ-KS-KY-2019-134
Status last verified
Dec 2019
First submitted
8 Dec 2019
Last updated
18 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer and Breast Cancer, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaonan Cui, MD, PHD (+8618098876725, cxn23@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04202848.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in