Condition or disease |
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Esophageal Squamous Cell Carcinoma |
Study Type : | Observational |
Estimated Enrollment : | 300 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Digestive Tract Tumor Research Based on ctDNA Methylation Detection Technology and Early Non-invasive Screening: Exploration and Verification of DNA Methylolation in Early Screening of Esophageal Cancer |
Actual Study Start Date : | March 1, 2019 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | March 31, 2021 |
Group/Cohort |
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Early esophageal cancer group
Pathological examination diagnosed as Early esophageal cancer.The ratio of male to female is 3:1, and the age is between 50 and 70 years old.
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Middle and advanced ES group
Pathological examination diagnosed as Middle and advanced esophageal cancer.
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Normal group
Confirmed as the normal by health checkups.
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Ages Eligible for Study: | 50 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: kaican cai | 13902205332 | doc_cai@163.com |
China, Guangdong | |
Nanfang Hospital of Southern Medical University | Recruiting |
Guangzhou, Guangdong, China, 510515 | |
Contact: Kaican Cai, MD 8620-61641822 doc_cai@163.com |
Study Director: | kaican cai | Nanfang Hospital of Southern Medical University |
Tracking Information | |||||
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First Submitted Date | March 15, 2019 | ||||
First Posted Date | April 19, 2019 | ||||
Last Update Posted Date | April 19, 2019 | ||||
Actual Study Start Date | March 1, 2019 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Hydroxymethylation level [ Time Frame: up to 2 years ] To compare the differences in hydroxymethylation levels among patients in different groups, to identify the hydroxymethylation genes associated with esophageal squamous cell carcinoma, and to verify the genes related to esophageal squamous cell carcinoma by ctDNA hydroxymethylation.
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Exploration and Verification of DNA Methylolation in Early Screening of Esophageal Cancer | ||||
Official Title | Digestive Tract Tumor Research Based on ctDNA Methylation Detection Technology and Early Non-invasive Screening: Exploration and Verification of DNA Methylolation in Early Screening of Esophageal Cancer | ||||
Brief Summary | The aim of this study was to detect the whole genome hydroxymethylation of peripheral blood ct DNA in normal population, patients with p0~pI esophageal squamous cell carcinoma and pII~pIV esophageal squamous cell carcinoma by using DNA methylation detection technology. To compare the differences in genomic methylation levels between different groups, to find out the methylolation site system associated with early esophageal squamous cell carcinoma, and to verify the genes related to esophageal squamous cell carcinoma by ctDNA methylolation. Application of basicization in early screening of esophageal squamous cell carcinoma. | ||||
Detailed Description | The aim of this study was to detect the whole genome hydroxymethylation of peripheral blood ct DNA in normal population, patients with p0~pI esophageal squamous cell carcinoma and pII~pIV esophageal squamous cell carcinoma by using DNA methylation detection technology. The differences in genomic methylation levels between different groups were compared to identify the methylolation site system associated with early esophageal squamous cell carcinoma. Then, using the genomic methylolation technique, 5hmC-DNA enrichment was performed on the peripheral venous blood samples of the experimental group before surgery and the peripheral venous blood samples of the control group, respectively, and then the high abundance and high significance were selected. The 5hmC-DNA fragment was verified by PCR amplification. The genes related to esophageal squamous cell carcinoma were verified by ctDNA methylolation. Finally, the methylolation genes related to esophageal squamous cell carcinoma were identified, and the application of DNA methylation in early screening of esophageal squamous cell carcinoma was explored. | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description:
Peripheral venous blood
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Sampling Method | Non-Probability Sample | ||||
Study Population | Population comes from the Nanfang Hospital of Southern Medical University. | ||||
Condition | Esophageal Squamous Cell Carcinoma | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
300 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | March 31, 2021 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 50 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03922230 | ||||
Other Study ID Numbers | NFEC-2019-015 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Nanfang Hospital of Southern Medical University | ||||
Study Sponsor | Nanfang Hospital of Southern Medical University | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Nanfang Hospital of Southern Medical University | ||||
Verification Date | February 2019 |