连全球医疗资源，享前沿医疗服务
4006 776 356
免费咨询 9:00-18:00
免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Colorectal Cancer Associated Host and Microbiome Study
Colorectal Cancer Associated Host and Microbiome Study
Study Description
Brief Summary:
Recruit of healthy, precancer and colorectal cancer patients and record necessary information of demographic and also other messages. All the volunteers were asked to provide samples including stool, blood, urine and tissues. This protocol is performed with the permission of the ethics committee and all the participants were provided with informed consent.
| Condition or disease |
|---|
| Colorectal Neoplasms |
Detailed Description:
Healthy subjects, precancer patients identified by colonoscopy or colonoscopy history and colorectal cancer patients identified by two independent pathologists will be enrolled. The demographic message including age, weight, height, drug history, family history of all participants will be recorded. Blood, stool and urine samples will be collected of all subjects. Tumor and adjacent tissue samples of colorectal cancer and precancer patients were collected, as well as normal tissue of healthy subjects.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 2000 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Cross-Sectional |
| Official Title: | A Study Focused on the Host and Microbiome of Colorectal Cancer Patients |
| Actual Study Start Date : | December 2015 |
| Estimated Primary Completion Date : | December 2020 |
| Estimated Study Completion Date : | December 2025 |
Arms and Interventions
| Group/Cohort |
|---|
|
healthy
Subjects without colorectal disorders.
|
|
precancerous
Subjects with risk factors that may contribute to the carcinogenesis.
|
|
colorectal cancer
Patients who were identified by standard procedures to suffer with colorectal cancer.
|
Outcome Measures
Primary Outcome Measures :
- Gut microbiota structure and function difference between colorectal cancer, precancer and healthy controls [ Time Frame: average of 5 years ]The results were based on the 16S rRNA metagenomic sequencing.
Secondary Outcome Measures :
- Metabolic difference of blood samples between colorectal cancer, precancer and healthy controls [ Time Frame: average of 5 years ]The metabolites of the blood samples by LC-MS will be detected.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Three different groups were created by healthy volunteers, precancerous and colorectal cancer patients. The information of these individuals will be analyzed and some conclusions will be drawn.
Criteria
Inclusion Criteria
- individuals who were clear and signed the informed consent.
- Male and female.
- Age >18
Exclusion Criteria:
- Any one who can not provide accurate information.
- Any one who denies the study.
- Younger than 18.
Contacts and Locations
Contacts
| Contact: Huanlong Qin, Ph.D | 86-021-66301161 | huanlqin@126.com |
Locations
| China, Shanghai | |
| Shanghai 10th People's Hospital | Recruiting |
| Shanghai, Shanghai, China, 200072 | |
| Contact: Renyuan Gao, MD renyuangao@126.com | |
| Principal Investigator: Huanlong Qin, PhD | |
Sponsors and Collaborators
Shanghai 10th People's Hospital
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | December 26, 2016 | ||||
| First Posted Date | June 26, 2019 | ||||
| Last Update Posted Date | July 2, 2019 | ||||
| Actual Study Start Date | December 2015 | ||||
| Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Gut microbiota structure and function difference between colorectal cancer, precancer and healthy controls [ Time Frame: average of 5 years ] The results were based on the 16S rRNA metagenomic sequencing.
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
Metabolic difference of blood samples between colorectal cancer, precancer and healthy controls [ Time Frame: average of 5 years ] The metabolites of the blood samples by LC-MS will be detected.
|
||||
| Original Secondary Outcome Measures |
Metabolic difference of blood samplesbetween colorectal cancer, precancer and healthy controls [ Time Frame: average of 5 years ] The metabolites of the blood samples will be detected.
|
||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Colorectal Cancer Associated Host and Microbiome Study | ||||
| Official Title | A Study Focused on the Host and Microbiome of Colorectal Cancer Patients | ||||
| Brief Summary | Recruit of healthy, precancer and colorectal cancer patients and record necessary information of demographic and also other messages. All the volunteers were asked to provide samples including stool, blood, urine and tissues. This protocol is performed with the permission of the ethics committee and all the participants were provided with informed consent. | ||||
| Detailed Description | Healthy subjects, precancer patients identified by colonoscopy or colonoscopy history and colorectal cancer patients identified by two independent pathologists will be enrolled. The demographic message including age, weight, height, drug history, family history of all participants will be recorded. Blood, stool and urine samples will be collected of all subjects. Tumor and adjacent tissue samples of colorectal cancer and precancer patients were collected, as well as normal tissue of healthy subjects. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Three different groups were created by healthy volunteers, precancerous and colorectal cancer patients. The information of these individuals will be analyzed and some conclusions will be drawn. | ||||
| Condition | Colorectal Neoplasms | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
2000 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 2025 | ||||
| Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts |
|
||||
| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03998644 | ||||
| Other Study ID Numbers | CCAHMS | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement |
|
||||
| Responsible Party | Huanlong Qin, Shanghai 10th People's Hospital | ||||
| Study Sponsor | Shanghai 10th People's Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Shanghai 10th People's Hospital | ||||
| Verification Date | June 2019 | ||||
