Esophageal Squamous Cell CarcinomaNCT03922230
Exploration and Verification of DNA Methylolation in Early Screening of Esophageal Cancer
An observational study of Esophageal Squamous Cell Carcinoma, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Mar 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population comes from the Nanfang Hospital of Southern Medical University.
Who may be able to join
- Diagnosis of esophageal squamous cell carcinoma by pathological cytology and histology.
- Clinically judged patients with p0~pIV initial treatment.（1 Variable risk factors are overeating food (habits) and family history. 2 Among all the patients, the ratio of male to female is 3:1, and the age is between 50 and 70 years old. In addition to eating too hot food, other eating habits (such as eating fresh fruits and vegetables, eating preserved food, etc.) are consistent, other factors (such as BMI, smoking, drinking, etc.) as much as possible. 3 In order to rule out the interference of other diseases, each sample needs to be determined to have no history of other diseases (such as neurodegenerative diseases, leukemia).）
- The normal population comes from the healthy population of Nanfang Hospital Health Center of Southern Medical University.
Who cannot join
- Preoperative patients have received relevant treatment, such as radiotherapy and chemotherapy;
- The subject has other diseases, such as tumors in other parts;
- Patients do not meet the age;
- There is no guarantee that other eating habits (such as eating fresh fruits and vegetables, not eating preserved foods) and other factors (such as BMI, smoking, drinking, etc.) are basically the same.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Kaican Cai, MD, 8620-61641822, doc_cai@163.com
About this study
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
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.
Read the 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.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- esophageal squamous cancer, DNA methylolation, early screening
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| Middle and advanced ES group | Pathological examination diagnosed as Middle and advanced esophageal cancer. | |
| Normal group | Confirmed as the normal by health checkups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydroxymethylation level
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.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start1 Mar 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- kaican cai, Study director, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922230
- Sponsor's protocol ID
- NFEC-2019-015
- Status last verified
- Feb 2019
- First submitted
- 15 Mar 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03922230
- Acronym / sponsor ID
- NFEC-2019-015
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- esophageal squamous cancer, DNA methylolation, early screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 19 Apr 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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Middle and advanced ES group | – | –Pathological examination diagnosed as Middle and advanced esophageal cancer. |
| Normal group | – | –Confirmed as the normal by health checkups. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population comes from the Nanfang Hospital of Southern Medical University.
Key inclusion criteria (3 listed)
- Diagnosis of esophageal squamous cell carcinoma by pathological cytology and histology.
- Clinically judged patients with p0~pIV initial treatment.（1 Variable risk factors are overeating food (habits) and family history. 2 Among all the patients, the ratio of male to female is 3:1, and the age is between 50 and 70 years old. In addition to eating too hot food, other eating habits (such as eating fresh fruits and vegetables, eating preserved food, etc.) are consistent, other factors (such as BMI, smoking, drinking, etc.) as much as possible. 3 In order to rule out the interference of other diseases, each sample needs to be determined to have no history of other diseases (such as neurodegenerative diseases, leukemia).）
- The normal population comes from the healthy population of Nanfang Hospital Health Center of Southern Medical University.
Key exclusion criteria (4 listed)
- Preoperative patients have received relevant treatment, such as radiotherapy and chemotherapy;
- The subject has other diseases, such as tumors in other parts;
- Patients do not meet the age;
- There is no guarantee that other eating habits (such as eating fresh fruits and vegetables, not eating preserved foods) and other factors (such as BMI, smoking, drinking, etc.) are basically the same.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
kaican cai study director
Nanfang Hospital, Southern Medical 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 Esophageal Squamous Cell Carcinoma, run by Nanfang Hospital, Southern Medical University 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 4 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 19 Apr 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 kaican cai (13902205332, doc_cai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hydroxymethylation level (time frame: up to 2 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 19 Apr 2019.