Gastrointestinal MicrobiomeIMMDCNCT04302363
Analysis of Intestinal Microflora Combined With DNA Methylation in Stool to Detect Colorectal Cancer
An observational study of Gastrointestinal Microbiome and DNA Methylation, run by WEIDONG LIU，MD at 1 site in China.
Trial summary
Introduction: Colorectal cancer (CRC) has the third highest incidence rate and the fourth mortality rate in the world. Traditional colonoscopy as an invasive examination method cannot be widely used in screening for colorectal neoplasia. The fecal immunochemical test has some limitations in sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Microbiome, DNA Methylation, Colorectal Neoplasms
- What is being tested?
- Fecal microbiota detection and exfoliated cell gene detection
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 1 Dec 2021
- 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 75 years
- All sexes
- Adult, Older adult
Study population: This program was performed in Xiangya Hospital(Still recruiting), Changsha, Hunan, China. Only participants who received a colonoscopy were enrolled
Who may be able to join
- colonoscopy revealing colon or rectal tumor and biopsy-confirmed adenocarcinoma or adenoma.
- no chemotherapy or surgery, and no history of other cancer.
- must be able to understand and be willing to sign informed consent.
- Healthy controls don't have tumors and history of cancer.
Who cannot join
- Those who not willing to provide specimens or answer questionnaires before the study began.
- People whose stool samples does not meet the requirements.
- People who are unwilling to sign written informed consent or follow a research protocol.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Liu wei dong, doctor, 0086-13873124855, davidcsu@foxmail.com
mingmei Liao, PhD
About this study
Official title: Analysis of Intestinal Microflora Combined With DNA Methylation in Stool to Detect Colorectal Cancer: a Study Protocol for Colorectal Neoplasms Screening
Introduction: Colorectal cancer (CRC) has the third highest incidence rate and the fourth mortality rate in the world. Traditional colonoscopy as an invasive examination method cannot be widely used in screening for colorectal neoplasia. The fecal immunochemical test has some limitations in sensitivity. Also, race and regional differences may affect results. Abnormality in the composition of the gut microbiota has been implicated as a potentially important etiologic factor in the initiation and progression of colorectal cancer. Analyzing fecal flora and exfoliated cell genes may represent a new screening tool for colorectal cancer.This research aims to use 16S rRNA to compare differences in fecal flora between colorectal cancer patients and healthy controls. These data combined with DNA findings of fecal exfoliated cells may further clarify this difference to build a model for screening early colorectal cancer in Chinese people.
Methods and analysis: In total, 300 patients with positive colonoscopy results and 200 health controls will be recruited. All participants will complete an information form and questionnaires. Fecal samples will be examined by 16S rRNA analysis. Gene methylation levels will be detected in fecal exfoliated cells. Models of related intestinal microbiota and methylation genes will be built. Receiver operating characteristic (ROC) curve analysis will be used to select some models with appropriate sensitivity and specificity.The models will be further validated by multicenter studys.
Read the detailed description
Introduction： Colorectal cancer (CRC) has the third highest incidence rate and the fourth mortality rate in the world. In China, CRC is the fifth leading cause of cancer deaths. Age-standardized incidence rates in CRC have shown an upward trend.A Westernized lifestyle, particularly physical inactivity, and an increase in the prevalence of obesity in recent decades in China may explain the increase in CRC incidence .
The 5-year survival rate for people with CRC is 65%. Survival rates for CRC can vary depending on various factors, particularly cancer stage. The 5-year survival rate with localized-stage CRC is 90%. About 39% of patients are diagnosed at this early stage. Because of the lack of typical clinical symptoms, early CRC is difficult to detect, and most patients are already in the advanced stage when CRC is diagnosed, thus missing the best intervention stage. Therefore, early detection and early treatment are effective means to reduce the mortality with CRC. Screening has benefits, including diagnosis at an earlier stage, reduced incidence of CRC and reduced mortality.
At present, the main screening methods for CRC are fecal occult blood test and colonoscopy. Colonoscopy is the gold standard for screening for CRC. However, traditional colonoscopy, an invasive examination method, cannot be widely used in screening for colorectal neoplasia.
Fecal samples are easily obtained.Using feces to screen CRC is the current research consensus. According to the most updated Asia Pacific consensus recommendations for CRC screening,FIT(fecal immunochemical test) is used to select high-risk patients for colonoscopy. FIT has also been widely used in other world regions . The sensitivity of FIT is limited (0.79; 95% CI, 0.69-0.86), and a recent systematic meta-analysis showed wide variation in sensitivity among studies . In addition, race and regional differences may affect test results. Therefore, the early screening methods which is non-invasive, highly sensitive and suitable for Chinese people are needed.
Detection of molecular biomarkers in feces for non-invasive diagnosis of CRC may be a promising alternative to detecting blood/plasma biomarkers in current clinical settings. Abnormalities in the composition of the gut microbiota have been implicated as potentially important causes of CRC. With the widespread use of metagenomic sequencing and pyrosequencing in intestinal microbiota research, more bacteria have been found positively associated with CRC incidence. In a recent study, 16S rRNA sequencing was used to classify microbial communities in human intestinal mucosa at different stages of colorectal tumorigenesis, and Fusobacterium was found enriched in colorectal tumors.
For CRC, the main process of benign polyps becoming malignant tumors is the accumulation of genetic and epigenetic alterations that transform colonic epithelial cells into colon adenocarcinoma cells. These cells are continuously shed into colonic lumen and mixed with the stool. During tumor formation, epigenetic changes may occur earlier than mutations. Deregulation of epigenetic mechanisms plays an important role in cancer. Most epigenetic changes in cancer are triggered by genomic alterations in specific genes that are involved in controlling one of the epigenetic mechanisms.Aberrant DNA methylation of tumor suppressor genes induces abnormal expression of downstream genes, which is an important step in the process of tumorigenesis.The methylation status of DNA changes during CRC progression. A number of gene methylation abnormalities associated with CRC discovered in recent studies include SFRP2, SEPT9, BMP3, NDRG4, and SPG20. In addition, some gene mutations are related to CRC. For example, TP53 and KRAS mutations are common in CRC.
In previous research the investigators found that SEPT9, NDRG4, and SDC2 had higher frequency and level of methylation in tumors than in normal or non-tumor adjacent CRC tissues, indicating that these methylated genes may have diagnostic potential for CRC screening. However, BMP3 had very limited contribution to detection accuracy in stool samples. Furthermore, the combination of methylated SEPT9, NDRG4, and SDC2 showed high feasibility of detection of CRC and adenoma and further study showed better performance in detecting CRC than adenoma. Our research also demonstrates differences in fecal genes between different ethnic groups.
This research aims to detect intestinal microbiota differences in stool by 16S rRNA analysis between CRC patients and healthy controls. It will combine DNA analysis of fecal exfoliated cells to further clarify this difference to build some models for screening early colorectal cancer in Chinese people. At the same time, the research will also study the impact of Chinese eating habits on Intestinal Microflora.
- Being tested
- Fecal microbiota detection and exfoliated cell gene detection
- Keywords
- Gastrointestinal Microbiome, DNA Methylation, Colorectal Neoplasms, Stool, biomaker
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota detection and exfoliated cell gene detectionOther
Fecal microbiota detection and exfoliated cell gene detection
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Healthy controls must be 18-75 years old with no tumors and no history of cancer. Receives: Other: Fecal microbiota detection and exfoliated cell gene detection | |
| Test Group | Inclusion criteria in the experimental group are age 18-75 years old, colonoscopy revealing colon or rectal tumor, biopsy-confirmed adenocarcinoma or adenoma, no chemotherapy or surgery, and no history of other cancer. Both groups must be able to understand and be willing to sign informed consent. Receives: Other: Fecal microbiota detection and exfoliated cell gene detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficacy of colorectal cancer model in Chinese people
the difference in intestinal flora and gene methylation between CRC patients and healthy individuals.
Measured: 2 years
Secondary outcomes (1)
Effect of diet on intestinal flora and DNA methylation in Chinese people
Investigate the frequency (e.g. ,"how many times a week"), quantity (e.g. ,"g") and types of food by semi-quantitative food frequency questionnaire (SQFFQ)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Feb 2018
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal MicrobiomeStudies 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WEIDONG LIU，MD
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Science Foundation of Hunan Province
- Responsible party
- Sponsor-investigator, WEIDONG LIU，MD, Xiangya Hospital of Central South University
- Investigators
- weidong Liu, PhD, Study chair, Xiangya Hospital of Central South Universitymingmei Liao, PhD, Study director, Xiangya Hospital of Central South Universityxi Xie, PhD, Principal investigator, Xiangya Hospital of Central South Universityjie Chen, PhD, Principal investigator, Xiangya Hospital of Central South Universityzhan Qu, PhD, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302363
- Sponsor's protocol ID
- CCRS-2
- Acronym
- IMMDC
- Status last verified
- Mar 2020
- First submitted
- 5 Nov 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.The data will be saved in digital form in the excel form and the image will be saved in PNG format.All data will be kept by Professor Wei-dong Liu.
Publications
Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-1502. doi: 10.1016/S0140-6736(13)61649-9. Epub 2013 Nov 11.
PubMed 24225001Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
PubMed 26808342Varghese C, Shin HR. Strengthening cancer control in China. Lancet Oncol. 2014 Apr;15(5):484-5. doi: 10.1016/S1470-2045(14)70056-7. No abstract available.
PubMed 24731401Wang YX, Zhu N, Zhang CJ, Wang YK, Wu HT, Li Q, Du K, Liao DF, Qin L. Friend or foe: Multiple roles of adipose tissue in cancer formation and progression. J Cell Physiol. 2019 Dec;234(12):21436-21449. doi: 10.1002/jcp.28776. Epub 2019 May 3.
PubMed 31054175Siegel RL, Miller KD, Fedewa SA, Ahnen DJ, Meester RGS, Barzi A, Jemal A. Colorectal cancer statistics, 2017. CA Cancer J Clin. 2017 May 6;67(3):177-193. doi: 10.3322/caac.21395. Epub 2017 Mar 1.
PubMed 28248415Hewitson P, Glasziou P, Watson E, Towler B, Irwig L. Cochrane systematic review of colorectal cancer screening using the fecal occult blood test (hemoccult): an update. Am J Gastroenterol. 2008 Jun;103(6):1541-9. doi: 10.1111/j.1572-0241.2008.01875.x. Epub 2008 May 13.
PubMed 18479499Sung JJ, Lau JY, Young GP, Sano Y, Chiu HM, Byeon JS, Yeoh KG, Goh KL, Sollano J, Rerknimitr R, Matsuda T, Wu KC, Ng S, Leung SY, Makharia G, Chong VH, Ho KY, Brooks D, Lieberman DA, Chan FK; Asia Pacific Working Group on Colorectal Cancer. Asia Pacific consensus recommendations for colorectal cancer screening. Gut. 2008 Aug;57(8):1166-76. doi: 10.1136/gut.2007.146316.
PubMed 18628378Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Ann Intern Med. 2014 Feb 4;160(3):171. doi: 10.7326/M13-1484.
PubMed 24658694Liang Q, Chiu J, Chen Y, Huang Y, Higashimori A, Fang J, Brim H, Ashktorab H, Ng SC, Ng SSM, Zheng S, Chan FKL, Sung JJY, Yu J. Fecal Bacteria Act as Novel Biomarkers for Noninvasive Diagnosis of Colorectal Cancer. Clin Cancer Res. 2017 Apr 15;23(8):2061-2070. doi: 10.1158/1078-0432.CCR-16-1599. Epub 2016 Oct 3.
PubMed 27697996Carmona FJ, Azuara D, Berenguer-Llergo A, Fernandez AF, Biondo S, de Oca J, Rodriguez-Moranta F, Salazar R, Villanueva A, Fraga MF, Guardiola J, Capella G, Esteller M, Moreno V. DNA methylation biomarkers for noninvasive diagnosis of colorectal cancer. Cancer Prev Res (Phila). 2013 Jul;6(7):656-65. doi: 10.1158/1940-6207.CAPR-12-0501. Epub 2013 May 21.
PubMed 23694962Maleszewska M, Wojtas B, Kaminska B. Deregulation of epigenetic mechanisms in cancer. Postepy Biochem. 2018 Oct 15;64(2):148-156. doi: 10.18388/pb.2018_125.
PubMed 30656897Park SK, Baek HL, Yu J, Kim JY, Yang HJ, Jung YS, Choi KY, Kim H, Kim HO, Jeong KU, Chun HK, Kim K, Park DI. Is methylation analysis of SFRP2, TFPI2, NDRG4, and BMP3 promoters suitable for colorectal cancer screening in the Korean population? Intest Res. 2017 Oct;15(4):495-501. doi: 10.5217/ir.2017.15.4.495. Epub 2017 Oct 23.
PubMed 29142517deVos T, Tetzner R, Model F, Weiss G, Schuster M, Distler J, Steiger KV, Grutzmann R, Pilarsky C, Habermann JK, Fleshner PR, Oubre BM, Day R, Sledziewski AZ, Lofton-Day C. Circulating methylated SEPT9 DNA in plasma is a biomarker for colorectal cancer. Clin Chem. 2009 Jul;55(7):1337-46. doi: 10.1373/clinchem.2008.115808. Epub 2009 Apr 30.
PubMed 19406918Melotte V, Lentjes MH, van den Bosch SM, Hellebrekers DM, de Hoon JP, Wouters KA, Daenen KL, Partouns-Hendriks IE, Stessels F, Louwagie J, Smits KM, Weijenberg MP, Sanduleanu S, Khalid-de Bakker CA, Oort FA, Meijer GA, Jonkers DM, Herman JG, de Bruine AP, van Engeland M. N-Myc downstream-regulated gene 4 (NDRG4): a candidate tumor suppressor gene and potential biomarker for colorectal cancer. J Natl Cancer Inst. 2009 Jul 1;101(13):916-27. doi: 10.1093/jnci/djp131. Epub 2009 Jun 17.
PubMed 19535783Okada S, Hata K, Kawai K, Yamamoto Y, Tanaka T, Nishikawa T, Sasaki K, Kaneko M, Emoto S, Murono K, Nozawa H. Association between KRAS G13D mutations and anastomotic recurrence in colorectal cancer: Two case reports. Medicine (Baltimore). 2019 Mar;98(12):e14781. doi: 10.1097/MD.0000000000014781.
PubMed 30896620
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Intestinal Microflora Combined With DNA Methylation in Stool to Detect Colorectal Cancer: a Study Protocol for Colorectal Neoplasms Screening
- ClinicalTrials.gov ID
- NCT04302363
- Acronym / sponsor ID
- IMMDC / CCRS-2
- Keywords
- Gastrointestinal Microbiome, DNA Methylation, Colorectal Neoplasms, Stool, biomaker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- WEIDONG LIU，MDUniversity, hospital or other
- Collaborators
- Natural Science Foundation of Hunan Province
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 10 Mar 2020 (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.
Introduction: Colorectal cancer (CRC) has the third highest incidence rate and the fourth mortality rate in the world. Traditional colonoscopy as an invasive examination method cannot be widely used in screening for colorectal neoplasia. The fecal immunochemical test has some limitations in sensitivity. Also, race and regional differences may affect results. Abnormality in the composition of the gut microbiota has been implicated as a potentially important etiologic factor in the initiation and progression of colorectal cancer. Analyzing fecal flora and exfoliated cell genes may represent a new screening tool for colorectal cancer.This research aims to use 16S rRNA to compare differences in fecal flora between colorectal cancer patients and healthy controls. These data combined with DNA findings of fecal exfoliated cells may further clarify this difference to build a model for screening early colorectal cancer in Chinese people.
Methods and analysis: In total, 300 patients with positive colonoscopy results and 200 health controls will be recruited. All participants will complete an information form and questionnaires. Fecal samples will be examined by 16S rRNA analysis. Gene methylation levels will be detected in fecal exfoliated cells. Models of related intestinal microbiota and methylation genes will be built. Receiver operating characteristic (ROC) curve analysis will be used to select some models with appropriate sensitivity and specificity.The models will be further validated by multicenter studys.
Detailed description
Introduction： Colorectal cancer (CRC) has the third highest incidence rate and the fourth mortality rate in the world. In China, CRC is the fifth leading cause of cancer deaths. Age-standardized incidence rates in CRC have shown an upward trend.A Westernized lifestyle, particularly physical inactivity, and an increase in the prevalence of obesity in recent decades in China may explain the increase in CRC incidence .
The 5-year survival rate for people with CRC is 65%. Survival rates for CRC can vary depending on various factors, particularly cancer stage. The 5-year survival rate with localized-stage CRC is 90%. About 39% of patients are diagnosed at this early stage. Because of the lack of typical clinical symptoms, early CRC is difficult to detect, and most patients are already in the advanced stage when CRC is diagnosed, thus missing the best intervention stage. Therefore, early detection and early treatment are effective means to reduce the mortality with CRC. Screening has benefits, including diagnosis at an earlier stage, reduced incidence of CRC and reduced mortality.
At present, the main screening methods for CRC are fecal occult blood test and colonoscopy. Colonoscopy is the gold standard for screening for CRC. However, traditional colonoscopy, an invasive examination method, cannot be widely used in screening for colorectal neoplasia.
Fecal samples are easily obtained.Using feces to screen CRC is the current research consensus. According to the most updated Asia Pacific consensus recommendations for CRC screening,FIT(fecal immunochemical test) is used to select high-risk patients for colonoscopy. FIT has also been widely used in other world regions . The sensitivity of FIT is limited (0.79; 95% CI, 0.69-0.86), and a recent systematic meta-analysis showed wide variation in sensitivity among studies . In addition, race and regional differences may affect test results. Therefore, the early screening methods which is non-invasive, highly sensitive and suitable for Chinese people are needed.
Detection of molecular biomarkers in feces for non-invasive diagnosis of CRC may be a promising alternative to detecting blood/plasma biomarkers in current clinical settings. Abnormalities in the composition of the gut microbiota have been implicated as potentially important causes of CRC. With the widespread use of metagenomic sequencing and pyrosequencing in intestinal microbiota research, more bacteria have been found positively associated with CRC incidence. In a recent study, 16S rRNA sequencing was used to classify microbial communities in human intestinal mucosa at different stages of colorectal tumorigenesis, and Fusobacterium was found enriched in colorectal tumors.
For CRC, the main process of benign polyps becoming malignant tumors is the accumulation of genetic and epigenetic alterations that transform colonic epithelial cells into colon adenocarcinoma cells. These cells are continuously shed into colonic lumen and mixed with the stool. During tumor formation, epigenetic changes may occur earlier than mutations. Deregulation of epigenetic mechanisms plays an important role in cancer. Most epigenetic changes in cancer are triggered by genomic alterations in specific genes that are involved in controlling one of the epigenetic mechanisms.Aberrant DNA methylation of tumor suppressor genes induces abnormal expression of downstream genes, which is an important step in the process of tumorigenesis.The methylation status of DNA changes during CRC progression. A number of gene methylation abnormalities associated with CRC discovered in recent studies include SFRP2, SEPT9, BMP3, NDRG4, and SPG20. In addition, some gene mutations are related to CRC. For example, TP53 and KRAS mutations are common in CRC.
In previous research the investigators found that SEPT9, NDRG4, and SDC2 had higher frequency and level of methylation in tumors than in normal or non-tumor adjacent CRC tissues, indicating that these methylated genes may have diagnostic potential for CRC screening. However, BMP3 had very limited contribution to detection accuracy in stool samples. Furthermore, the combination of methylated SEPT9, NDRG4, and SDC2 showed high feasibility of detection of CRC and adenoma and further study showed better performance in detecting CRC than adenoma. Our research also demonstrates differences in fecal genes between different ethnic groups.
This research aims to detect intestinal microbiota differences in stool by 16S rRNA analysis between CRC patients and healthy controls. It will combine DNA analysis of fecal exfoliated cells to further clarify this difference to build some models for screening early colorectal cancer in Chinese people. At the same time, the research will also study the impact of Chinese eating habits on Intestinal Microflora.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Other: Fecal microbiota detection and exfoliated cell gene detectionHealthy controls must be 18-75 years old with no tumors and no history of cancer. |
| Test Group | – | Other: Fecal microbiota detection and exfoliated cell gene detectionInclusion criteria in the experimental group are age 18-75 years old, colonoscopy revealing colon or rectal tumor, biopsy-confirmed adenocarcinoma or adenoma, no chemotherapy or surgery, and no history of other cancer. Both groups must be able to understand and be willing to sign informed consent. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This program was performed in Xiangya Hospital(Still recruiting), Changsha, Hunan, China. Only participants who received a colonoscopy were enrolled
Key inclusion criteria (4 listed)
- colonoscopy revealing colon or rectal tumor and biopsy-confirmed adenocarcinoma or adenoma.
- no chemotherapy or surgery, and no history of other cancer.
- must be able to understand and be willing to sign informed consent.
- Healthy controls don't have tumors and history of cancer.
Key exclusion criteria (3 listed)
- Those who not willing to provide specimens or answer questionnaires before the study began.
- People whose stool samples does not meet the requirements.
- People who are unwilling to sign written informed consent or follow a research protocol.
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 |
|---|---|---|
| Fecal microbiota detection and exfoliated cell gene detectionFecal microbiota detection and exfoliated cell gene detection | Other | Control Group, Test Group |
Primary outcome
Diagnostic efficacy of colorectal cancer model in Chinese people
Time frame: 2 years
the difference in intestinal flora and gene methylation between CRC patients and healthy individuals.
1 secondary outcome
Effect of diet on intestinal flora and DNA methylation in Chinese people
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Results publication: PubMed 24225001Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-1502. doi: 10.1016/S0140-6736(13)61649-9. Epub 2013 Nov 11.
- Results publication: PubMed 26808342Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
- Results publication: PubMed 24731401Varghese C, Shin HR. Strengthening cancer control in China. Lancet Oncol. 2014 Apr;15(5):484-5. doi: 10.1016/S1470-2045(14)70056-7. No abstract available.
- Results publication: PubMed 31054175Wang YX, Zhu N, Zhang CJ, Wang YK, Wu HT, Li Q, Du K, Liao DF, Qin L. Friend or foe: Multiple roles of adipose tissue in cancer formation and progression. J Cell Physiol. 2019 Dec;234(12):21436-21449. doi: 10.1002/jcp.28776. Epub 2019 May 3.
- Results publication: PubMed 28248415Siegel RL, Miller KD, Fedewa SA, Ahnen DJ, Meester RGS, Barzi A, Jemal A. Colorectal cancer statistics, 2017. CA Cancer J Clin. 2017 May 6;67(3):177-193. doi: 10.3322/caac.21395. Epub 2017 Mar 1.
- Results publication: PubMed 18479499Hewitson P, Glasziou P, Watson E, Towler B, Irwig L. Cochrane systematic review of colorectal cancer screening using the fecal occult blood test (hemoccult): an update. Am J Gastroenterol. 2008 Jun;103(6):1541-9. doi: 10.1111/j.1572-0241.2008.01875.x. Epub 2008 May 13.
- Results publication: PubMed 18628378Sung JJ, Lau JY, Young GP, Sano Y, Chiu HM, Byeon JS, Yeoh KG, Goh KL, Sollano J, Rerknimitr R, Matsuda T, Wu KC, Ng S, Leung SY, Makharia G, Chong VH, Ho KY, Brooks D, Lieberman DA, Chan FK; Asia Pacific Working Group on Colorectal Cancer. Asia Pacific consensus recommendations for colorectal cancer screening. Gut. 2008 Aug;57(8):1166-76. doi: 10.1136/gut.2007.146316.
- Results publication: PubMed 24658694Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Ann Intern Med. 2014 Feb 4;160(3):171. doi: 10.7326/M13-1484.
- Results publication: PubMed 27697996Liang Q, Chiu J, Chen Y, Huang Y, Higashimori A, Fang J, Brim H, Ashktorab H, Ng SC, Ng SSM, Zheng S, Chan FKL, Sung JJY, Yu J. Fecal Bacteria Act as Novel Biomarkers for Noninvasive Diagnosis of Colorectal Cancer. Clin Cancer Res. 2017 Apr 15;23(8):2061-2070. doi: 10.1158/1078-0432.CCR-16-1599. Epub 2016 Oct 3.
- Results publication: PubMed 23694962Carmona FJ, Azuara D, Berenguer-Llergo A, Fernandez AF, Biondo S, de Oca J, Rodriguez-Moranta F, Salazar R, Villanueva A, Fraga MF, Guardiola J, Capella G, Esteller M, Moreno V. DNA methylation biomarkers for noninvasive diagnosis of colorectal cancer. Cancer Prev Res (Phila). 2013 Jul;6(7):656-65. doi: 10.1158/1940-6207.CAPR-12-0501. Epub 2013 May 21.
- Results publication: PubMed 30656897Maleszewska M, Wojtas B, Kaminska B. Deregulation of epigenetic mechanisms in cancer. Postepy Biochem. 2018 Oct 15;64(2):148-156. doi: 10.18388/pb.2018_125.
- Results publication: PubMed 29142517Park SK, Baek HL, Yu J, Kim JY, Yang HJ, Jung YS, Choi KY, Kim H, Kim HO, Jeong KU, Chun HK, Kim K, Park DI. Is methylation analysis of SFRP2, TFPI2, NDRG4, and BMP3 promoters suitable for colorectal cancer screening in the Korean population? Intest Res. 2017 Oct;15(4):495-501. doi: 10.5217/ir.2017.15.4.495. Epub 2017 Oct 23.
- Individual participant dataSharing planned: Undecided. Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.The data will be saved in digital form in the excel form and the image will be saved in PNG format.All data will be kept by Professor Wei-dong Liu.
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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.
weidong Liu, PhD study chair
Xiangya Hospital of Central South University
mingmei Liao, PhD study director
Xiangya Hospital of Central South University
xi Xie, PhD principal investigator
Xiangya Hospital of Central South University
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 Gastrointestinal Microbiome and DNA Methylation, run by WEIDONG LIU，MD 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 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 10 Mar 2020. 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 weidong Liu, PhD (86-13873124855, weidong.liu@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic efficacy of colorectal cancer model in Chinese people (time frame: 2 years). 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 NCT04302363, which also lists 19 linked publications.
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 10 Mar 2020.