Colorectal NeoplasmsNCT02845973
Study of Fecal Bacteria in Early Diagnosis of Colorectal Cancer
An observational study of Colorectal Neoplasms, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The aim of the study is to identify and verify one or more gut bacteria of which the abundance in feces may help to early diagnosis colorectal cancer. Read more about this study
- Who is it for?
- Ages 40 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- gut microbiota
- How many people
- 1,325 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Jul 2017
- 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 40 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese people
Who may be able to join
- Patients age from 40 to 85 years old
- Patients with endoscopic or pathological confirmed healthy, adenoma, inflammation, early or late stage of colorectal cancer
- Patients with valid CEA(carcino embryonic antigen) and OB(occult blood) test result in 1 year before or after the coloscopy or surgery
Who cannot join
- Patients with history of colorectal cancer
- Patients with long term use of antibiotics or probiotics
- Patients with uncontrolled diabetes, hypertension or hepatitis
- Patients with a history of subtotal gastrectomy or partial bowel resection
- Patients who are not able to cooperate
- Patients with medical conditions who are not appropriate to participate the study
- Patients who are taking aspirin, NSAIDs (nonsteroidal antiinflammatory drugs), COX2(cyclo-oxygen-ase 2) inhibitors.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to identify and verify one or more gut bacteria of which the abundance in feces may help to early diagnosis colorectal cancer.
Read the detailed description
Gut microbiota is closely related to human gut neoplasm. According to recent statistics, the abundance of FN (Fusobacterium Nucleatum) is connected with the development and progression of CRCs (colorectal cancers). Subsequent research shows identifying multiple microbial-specific genes in human feces using qPCR (quantitative Polymerase Chain Reaction) may help diagnosis of early stage colorectal cancer. Currently little is known about the relationship between single abundance of specific gut microbiota and colorectal cancer in different stage. Moreover, finding early-stage CRCs is still of great challenge partially due to precancerous diseases like colorectal adenoma which remain difficult to differentiate from early-stage CRC under endoscope. Conventional clinic methods predicting CRCs largely depend on serum CEA (serum Carcino Embryonic Antigen) and OB(fecal occult blood test), which lack of adequate sensitivity and specificity especially in early stage CRCs. The investigators' work focuses on the abundance of gut microbiota in feces from people with colon neoplasm and its comparison with classical indicators such as CEA and OB, aiming to reveal and testify its potential role on assisting diagnosis of CRCs in different stage as a none-invasive cost-effective method.
- Conditions
- Colorectal Neoplasms
- Being tested
- gut microbiota
- Keywords
- gut microbiota
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gut microbiotaBiological
| Study group | Role | What they receive |
|---|---|---|
| test cohort | The test cohort was from Fudan University Shanghai Cancer Center (August 2016 to December 2016) and ECRJ-East Campus of Renji hospital (January 2012 to March 2017); Receives: Biological: gut microbiota | |
| validation cohort | The validation cohort was from Shanghai Tenth People's Hospital (October 2015 to November 2016) and WCRJ-West Campus of Renji hospital (July 2016 to March 2017) Receives: Biological: gut microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in abundance of gut microbiota
differences in abundance of gut microbiota for participants with different clinical outcomes confirmed by qPCR(quantitive polymerase chain reaction)
Measured: 1 year
Secondary outcomes (1)
evidence of colorectal neoplasia
Different outcomes for colorectal neoplasia confirmed by coloscopy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startJan 2012
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, Fudan University
- Responsible party
- Principal investigator, Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845973
- Sponsor's protocol ID
- RJ20160701
- Status last verified
- Nov 2019
- First submitted
- 17 Jul 2016
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xie YH, Gao QY, Cai GX, Sun XM, Sun XM, Zou TH, Chen HM, Yu SY, Qiu YW, Gu WQ, Chen XY, Cui Y, Sun D, Liu ZJ, Cai SJ, Xu J, Chen YX, Fang JY. Fecal Clostridium symbiosum for Noninvasive Detection of Early and Advanced Colorectal Cancer: Test and Validation Studies. EBioMedicine. 2017 Nov;25:32-40. doi: 10.1016/j.ebiom.2017.10.005. Epub 2017 Oct 4.
PubMed 29033369
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Fecal Bacteria in Early Diagnosis of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02845973
- Acronym / sponsor ID
- RJ20160701
- Conditions
- Colorectal Neoplasms
- Keywords
- gut microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,325 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, Fudan University
- Study start
- Jan 2012 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 27 Jul 2016 (estimated)
- 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.
The aim of the study is to identify and verify one or more gut bacteria of which the abundance in feces may help to early diagnosis colorectal cancer.
Detailed description
Gut microbiota is closely related to human gut neoplasm. According to recent statistics, the abundance of FN (Fusobacterium Nucleatum) is connected with the development and progression of CRCs (colorectal cancers). Subsequent research shows identifying multiple microbial-specific genes in human feces using qPCR (quantitative Polymerase Chain Reaction) may help diagnosis of early stage colorectal cancer. Currently little is known about the relationship between single abundance of specific gut microbiota and colorectal cancer in different stage. Moreover, finding early-stage CRCs is still of great challenge partially due to precancerous diseases like colorectal adenoma which remain difficult to differentiate from early-stage CRC under endoscope. Conventional clinic methods predicting CRCs largely depend on serum CEA (serum Carcino Embryonic Antigen) and OB(fecal occult blood test), which lack of adequate sensitivity and specificity especially in early stage CRCs. The investigators' work focuses on the abundance of gut microbiota in feces from people with colon neoplasm and its comparison with classical indicators such as CEA and OB, aiming to reveal and testify its potential role on assisting diagnosis of CRCs in different stage as a none-invasive cost-effective method.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test cohort | – | Biological: gut microbiotaThe test cohort was from Fudan University Shanghai Cancer Center (August 2016 to December 2016) and ECRJ-East Campus of Renji hospital (January 2012 to March 2017); |
| validation cohort | – | Biological: gut microbiotaThe validation cohort was from Shanghai Tenth People's Hospital (October 2015 to November 2016) and WCRJ-West Campus of Renji hospital (July 2016 to March 2017) |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese people
Key inclusion criteria (3 listed)
- Patients age from 40 to 85 years old
- Patients with endoscopic or pathological confirmed healthy, adenoma, inflammation, early or late stage of colorectal cancer
- Patients with valid CEA(carcino embryonic antigen) and OB(occult blood) test result in 1 year before or after the coloscopy or surgery
Key exclusion criteria (7 listed)
- Patients with history of colorectal cancer
- Patients with long term use of antibiotics or probiotics
- Patients with uncontrolled diabetes, hypertension or hepatitis
- Patients with a history of subtotal gastrectomy or partial bowel resection
- Patients who are not able to cooperate
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 |
|---|---|---|
| gut microbiota | Biological | test cohort, validation cohort |
Primary outcome
differences in abundance of gut microbiota
Time frame: 1 year
differences in abundance of gut microbiota for participants with different clinical outcomes confirmed by qPCR(quantitive polymerase chain reaction)
1 secondary outcome
evidence of colorectal neoplasia
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Results publication: PubMed 29033369Xie YH, Gao QY, Cai GX, Sun XM, Sun XM, Zou TH, Chen HM, Yu SY, Qiu YW, Gu WQ, Chen XY, Cui Y, Sun D, Liu ZJ, Cai SJ, Xu J, Chen YX, Fang JY. Fecal Clostridium symbiosum for Noninvasive Detection of Early and Advanced Colorectal Cancer: Test and Validation Studies. EBioMedicine. 2017 Nov;25:32-40. doi: 10.1016/j.ebiom.2017.10.005. Epub 2017 Oct 4.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Jiao Tong University School of Medicine 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 7 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: finished, as of the sponsor's last update on 26 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differences in abundance of gut microbiota (time frame: 1 year). 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 NCT02845973, which also lists 1 linked publication.
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 26 Nov 2019.