Colorectal NeoplasmsNCT03998644
Colorectal Cancer Associated Host and Microbiome Study
An observational study of Colorectal Neoplasms, run by Shanghai 10th People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- individuals who were clear and signed the informed consent.
- Male and female.
- Age >18
Who cannot join
- Any one who can not provide accurate information.
- Any one who denies the study.
- Younger than 18.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, 200072
Renyuan Gao, MD, renyuangao@126.com
Huanlong Qin, PhD
About this study
Official title: A Study Focused on the Host and Microbiome of Colorectal Cancer Patients
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.
Read the 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.
- Conditions
- Colorectal Neoplasms
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota structure and function difference between colorectal cancer, precancer and healthy controls
The results were based on the 16S rRNA metagenomic sequencing.
Measured: average of 5 years
Secondary outcomes (1)
Metabolic difference of blood samples between colorectal cancer, precancer and healthy controls
The metabolites of the blood samples by LC-MS will be detected.
Measured: average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study startDec 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huanlong Qin, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998644
- Sponsor's protocol ID
- CCAHMS
- Status last verified
- Jun 2019
- First submitted
- 26 Dec 2016
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Focused on the Host and Microbiome of Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT03998644
- Acronym / sponsor ID
- CCAHMS
- Conditions
- Colorectal Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- individuals who were clear and signed the informed consent.
- Male and female.
- Age >18
Key exclusion criteria (3 listed)
- Any one who can not provide accurate information.
- Any one who denies the study.
- Younger than 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | colorectal cancer, healthy, precancerous |
Primary outcome
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.
1 secondary outcome
Metabolic difference of blood samples between colorectal cancer, precancer and healthy controls
Time frame: average of 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by Shanghai 10th People's Hospital 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 3 inclusion and 3 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 2 Jul 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 Huanlong Qin, Ph.D (86-021-66301161, huanlqin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota structure and function difference between colorectal cancer, precancer and healthy controls (time frame: average of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2019.