A Model for the Early Diagnosis of Colorectal Cancer by the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA
A Single-centre, Prospective Trial of the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA for Establishing a Model for the Early Diagnosis of Colorectal Cancer
1 other identifier
observational
1,400
1 country
1
Brief Summary
In this study, the investigators establish a model for the early diagnosis of colorectal cancer based on detection of 5-hydroxymethylcytosine (5-hmC) in training group and validate the effectiveness of the model using a validation group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 16, 2018
CompletedFirst Submitted
Initial submission to the registry
July 17, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedJuly 26, 2018
January 1, 2018
11 months
July 17, 2018
July 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity of the model in the diagnosis of colorectal cancer
Sensitivity and specificity of the model in the diagnosis of colorectal cancer in training group and validation group
6-month
Eligibility Criteria
Adults diagnosed with colorectal cancer or with normal colonoscopy.
You may qualify if:
- Arm A
- Histologically proven colorectal adenocarcinoma
- No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
- Eastern cooperative oncology group score 0-2
- Informed consent
- Arm B
- Healthy people with normal colonoscopy
- No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
- Eastern cooperative oncology group score 0-2
- Informed consent
You may not qualify if:
- Arm A
- Patients received chemoradiotherapy or other anti-tumor therapy before being enrolled
- Patients and/or family members can not understand and accept this study
- Familial Adenomatosis Polyposis, Lynch Syndrome, acute inflammatory bowel disease
- Pregnancy or lactation
- Unsuitable to take part in the clinical trial judged by doctors
- Arm B
- Pregnancy or lactation
- Unsuitable to take part in the clinical trial judged by doctors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Wenju Chang
Shanghai, Shanghai Municipality, 200032, China
Biospecimen
Peripheral venous blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
July 17, 2018
First Posted
July 26, 2018
Study Start
July 16, 2018
Primary Completion
May 31, 2019
Study Completion
May 31, 2019
Last Updated
July 26, 2018
Record last verified: 2018-01