Colorectal CancerNCT03676075
A Multi-center Trial to Establish a Model for the Early Diagnosis of Colorectal Cancer by the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA
An observational study of Colorectal Cancer and Adenoma, run by Fudan University at 1 site in China.
Trial summary
In this study, the investigators establish a model for the early diagnosis of colorectal cancer based on the detection of 5-hydroxymethylcytosine (5-hmC) in training group and validate the effectiveness of the model using a validation group recruited from multiple centers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Adenoma
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 30 Jun 2019
- How long will I take part?
- 1 Month
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults diagnosed with colorectal cancer, adenoma or with normal colonoscopy.
Who may be able to join
- 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
Show all 15Show fewer
- Histologically proven colorectal adenoma
- 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 C
- 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
Who cannot join
- 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
Show all 16Show fewer
- Arm B
- Patients received endoscopic resection 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 C
- Patients and/or family members can not understand and accept this study
- Pregnancy or lactation
- Unsuitable to take part in the clinical trial judged by doctors
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wenju Chang
Shanghai, Shanghai Municipality, 200032
Wenju Chang, MD, +8613764476150, chang_erich@hotmail.com
About this study
Official title: A Multi-center, 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
In this study, the investigators establish a model for the early diagnosis of colorectal cancer based on the detection of 5-hydroxymethylcytosine (5-hmC) in training group and validate the effectiveness of the model using a validation group recruited from multiple centers.
Read the detailed description
According to precious studies, 5-methylcytosine (5-mC) and 5-hydroxymethylcytosine (5-hmC) are both important epigenetic markers whose changes are associated with many kinds of diseases, including cancers. This changes may help diagnose cancer. The new detection method for 5-hmC can meet the requirements of liquid biopsy.
The traditional diagnostic methods for colorectal cancer is colonoscopy and pathology which are inconvenient and unpleasant, and sometimes, it is difficult for the very patients to get tissues or get enough tissues to confirm the pathologic diagnosis. In addition, other screening methods for colorectal cancer,such as guaiac-based fecal occult blood testing and a blood test for methylated SEPT9 DNA, have the shortcomings of relatively low sensitivity and specificity. As a result, it is imperative to find a new detection method for early diagnosis of colorectal cancer with the advantages of high sensitivity and specificity, minimally invasive and convenient.
The aim of this multi-center research is to establish a model for the early diagnosis of colorectal cancer by the detection of 5-hmC in plasma cell-free DNA. Patients who are diagnosed with colorectal cancer by colonoscopy and pathology and not received any anti-tumor therapy (Arm A) will be eligible for inclusion. In addition, patients who suffer with adenoma and not received endoscopic resection (Arm B) will be eligible as well as healthy individuals with normal colonoscopy (Arm C). Then, 5-hmC in plasma cell-free DNA will be detected and compared among the three arms of patients (training group) to establish a model to diagnosis other individuals (validation group) who may suffer from colorectal cancer or adenoma.
- Conditions
- Colorectal Cancer, Adenoma
- Keywords
- colorectal cancer, early diagnosis, 5-hydroxymethylcytosine
- Medical subject headings
- Colorectal Neoplasms, Adenoma, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma
Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma in training group and validation group
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Dec 2018 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676075
- Sponsor's protocol ID
- METHOD-2
- Status last verified
- Aug 2018
- First submitted
- 16 Sep 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, 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
- ClinicalTrials.gov ID
- NCT03676075
- Acronym / sponsor ID
- METHOD-2
- Conditions
- Colorectal Cancer, Adenoma
- Keywords
- colorectal cancer, early diagnosis, 5-hydroxymethylcytosine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 18 Sep 2018 (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.
In this study, the investigators establish a model for the early diagnosis of colorectal cancer based on the detection of 5-hydroxymethylcytosine (5-hmC) in training group and validate the effectiveness of the model using a validation group recruited from multiple centers.
Detailed description
According to precious studies, 5-methylcytosine (5-mC) and 5-hydroxymethylcytosine (5-hmC) are both important epigenetic markers whose changes are associated with many kinds of diseases, including cancers. This changes may help diagnose cancer. The new detection method for 5-hmC can meet the requirements of liquid biopsy.
The traditional diagnostic methods for colorectal cancer is colonoscopy and pathology which are inconvenient and unpleasant, and sometimes, it is difficult for the very patients to get tissues or get enough tissues to confirm the pathologic diagnosis. In addition, other screening methods for colorectal cancer,such as guaiac-based fecal occult blood testing and a blood test for methylated SEPT9 DNA, have the shortcomings of relatively low sensitivity and specificity. As a result, it is imperative to find a new detection method for early diagnosis of colorectal cancer with the advantages of high sensitivity and specificity, minimally invasive and convenient.
The aim of this multi-center research is to establish a model for the early diagnosis of colorectal cancer by the detection of 5-hmC in plasma cell-free DNA. Patients who are diagnosed with colorectal cancer by colonoscopy and pathology and not received any anti-tumor therapy (Arm A) will be eligible for inclusion. In addition, patients who suffer with adenoma and not received endoscopic resection (Arm B) will be eligible as well as healthy individuals with normal colonoscopy (Arm C). Then, 5-hmC in plasma cell-free DNA will be detected and compared among the three arms of patients (training group) to establish a model to diagnosis other individuals (validation group) who may suffer from colorectal cancer or adenoma.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with colorectal cancer, adenoma or with normal colonoscopy.
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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
Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma
Time frame: 6 months
Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma in training group and validation group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
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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.
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 Cancer and Adenoma, run by Fudan 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 15 inclusion and 16 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 18 Sep 2018. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma (time frame: 6 months). 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 18 Sep 2018.