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Correlation Analysis of TCM Syndromes, TCM Constitution Types, Intestinal Microbial Evolution and Tumor Biological Characteristics in Colorectal Cancer Patients Before and After Surgery

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ClinicalTrials.gov Identifier: NCT03892252
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Wei Xu, First Affiliated Hospital of Harbin Medical University

Brief Summary:
Guided by the idea of combining disease differentiation with syndrome differentiation in traditional Chinese medicine, this study used the form of questionnaire to summarize the changes of TCM syndromes, TCM constitution types in colorectal cancer patients before and after surgery. The Next-generation sequencing technology was used to explore the changes and differences of intestinal microorganisms before and after surgery. The correlation between changes of TCM syndromes, TCM constitution types, intestinal microbial evolution and tumor biological characteristics in colorectal cancer patients before and after surgery was analyzed. To explore the rationality of TCM in the prevention and treatment of colorectal cancer recurrence and metastasis in order to guide the individualized treatment and dietary regulation of TCM.

Condition or disease
Colorectal Neoplasms

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Correlation Analysis of TCM Syndromes, TCM Constitution Types, Intestinal Microbial Evolution and Tumor Biological Characteristics in Colorectal Cancer Patients Before and After Surgery
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : March 14, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
before surgery
no intervention(s)
after surgery
no intervention(s)



Primary Outcome Measures :
  1. According to the taxonomy information, differences among specimens or among clinical groups were analyzed using principal component analysis (PCA). [ Time Frame: 1 year ]
  2. All OTU data obtained from 16S rRNA sequencing and were processed using the caret (v6.0.76) R package. [ Time Frame: 1 year ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Colorectal cancer patients admitted to the first affiliated hospital of Harbin medical university
Criteria

Inclusion Criteria:

  1. Preoperative abdominal CT, colonoscopy and pathological examination were diagnosed as colorectal malignant tumor patients;
  2. Having surgical indications;
  3. Patients who were not treated with antibiotics or microbiological agents one week before surgery;
  4. Patients who had not received radiotherapy and chemotherapy before surgery;
  5. Patients or their legal representatives informed and agreed to participate in this clinical trial and signed a written informed consent;

Exclusion Criteria:

  1. Have other cancer history;
  2. Patients who have received invasive treatment within the past three months;
  3. Inflammatory bowel disease such as ulcerative colitis or crohn's disease;
  4. Combined with intestinal obstruction or intestinal perforation for emergency surgery;
  5. Psychiatric history, can not join and standardize the completion of clinical investigators;
  6. Pregnant or nursing women;
  7. Patients treated with antibiotics or microbiological agents one week before surgery;
  8. People have incomplete data;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892252


Contacts
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Contact: Wei Xu, Professor 0451-85555815 13796059990@163.com
Contact: Xun Da Piao, Professor 0451-85555183 piaodaxun@sina.com

Locations
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China, Heilongjiang
The First Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150001
Contact: Wei Xu, Professor    0451-85555815    13796059990@163.com   
Sponsors and Collaborators
Wei Xu
Investigators
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Principal Investigator: Wei Xu, Professor First Affiliated Hospital of Harbin Medical University

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Responsible Party: Wei Xu, Professor, First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT03892252     History of Changes
Other Study ID Numbers: V1.0
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases