Colorectal CancerNCT03868215
Use of Plasma ctDNA Methylation Haplotypes in Detecting Local Residual or Lymph Node Metastasis
An observational study of Colorectal Cancer and Lymph Node Metastases, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, clinical study. This study is to evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Lymph Node Metastases
- What is being tested?
- Next-generation sequencing (NGS)
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 31 Aug 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with endoscopically removed malignant polyps must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent.
Who may be able to join
- Patients with endoscopically removed malignant polyps.
- Male or female ≥ 18 years of age on the day of signing informed consent.
- Patients who received surgical resection following removal of malignant polyps by colonoscopy.
- Patients must have a performance status of ≤1 on the ECOG Performance Scale.
- Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study
Who cannot join
- Patients received adjuvant treatment prior to the surgical resection.
- Patients received blood transfusion two weeks before or during the surgical resection.
- Patients with unresected advanced colorectal adenoma.
- Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
- Patients who are pregnant.
- Patients who are alcoholic or drug abusers.
- Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Guoxiang Cai, M.D. Ph.D.
About this study
Official title: Use of Plasma ctDNA Methylation Haplotypes in Detecting Local Residual or Lymph Node Metastasis: a Prospective, Clinical Study
This is a prospective, clinical study. This study is to evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis.
Read the detailed description
Colorectal cancer (CRC) is the third most common cancer worldwide, the second deadliest cancer in the United States. DNA methylation is a commonly used biomarker for non-invasive CRC detection in plasma. The low sensitivity of blood-based tests is due to several limitations of detecting ctDNA in early-stage cancer. We developed and validated a high-throughput methylation-based blood test highly sensitive for colorectal cancer and precancerous lesions. This previously established colorectal tumor-specific plasma ctDNA methylation markers (diagnostic model established by next-generation sequencing of 2181 gene loci methylation) had a high sensitivity in CRC patients and a high specificity in healthy individuals in a large retrospective sample study. This prospective, clinical study is to further evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis.
- Conditions
- Colorectal Cancer, Lymph Node Metastases
- Being tested
- Next-generation sequencing (NGS)
- Keywords
- Colorectal Cancer, Lymph Node Metastases, Local Residual
- Medical subject headings
- Colorectal Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next-generation sequencing (NGS)Diagnostic test
NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy and before surgical resection.
| Study group | Role | What they receive |
|---|---|---|
| Patients with endoscopically removed malignant polyps | Patients with endoscopically removed malignant polyps Receives: Diagnostic Test: Next-generation sequencing (NGS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
The sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 May 2018
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2020 (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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoxiang Cai, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868215
- Sponsor's protocol ID
- FDLNM-CGX
- Status last verified
- Mar 2019
- First submitted
- 9 Nov 2018
- Last updated
- 11 Mar 2019
- 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 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Plasma ctDNA Methylation Haplotypes in Detecting Local Residual or Lymph Node Metastasis: a Prospective, Clinical Study
- ClinicalTrials.gov ID
- NCT03868215
- Acronym / sponsor ID
- FDLNM-CGX
- Conditions
- Colorectal Cancer, Lymph Node Metastases
- Keywords
- Colorectal Cancer, Lymph Node Metastases, Local Residual
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 11 Mar 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.
This is a prospective, clinical study. This study is to evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis.
Detailed description
Colorectal cancer (CRC) is the third most common cancer worldwide, the second deadliest cancer in the United States. DNA methylation is a commonly used biomarker for non-invasive CRC detection in plasma. The low sensitivity of blood-based tests is due to several limitations of detecting ctDNA in early-stage cancer. We developed and validated a high-throughput methylation-based blood test highly sensitive for colorectal cancer and precancerous lesions. This previously established colorectal tumor-specific plasma ctDNA methylation markers (diagnostic model established by next-generation sequencing of 2181 gene loci methylation) had a high sensitivity in CRC patients and a high specificity in healthy individuals in a large retrospective sample study. This prospective, clinical study is to further evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with endoscopically removed malignant polyps | – | Diagnostic Test: Next-generation sequencing (NGS)Patients with endoscopically removed malignant polyps |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with endoscopically removed malignant polyps must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent.
Key inclusion criteria (5 listed)
- Patients with endoscopically removed malignant polyps.
- Male or female ≥ 18 years of age on the day of signing informed consent.
- Patients who received surgical resection following removal of malignant polyps by colonoscopy.
- Patients must have a performance status of ≤1 on the ECOG Performance Scale.
- Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study
Key exclusion criteria (7 listed)
- Patients received adjuvant treatment prior to the surgical resection.
- Patients received blood transfusion two weeks before or during the surgical resection.
- Patients with unresected advanced colorectal adenoma.
- Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
- Patients who are pregnant.
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 |
|---|---|---|
| Next-generation sequencing (NGS)NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy and before surgical resection. | Diagnostic test | Patients with endoscopically removed malignant polyps |
Primary outcome
Sensitivity
Time frame: 2 years
The sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
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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 Lymph Node Metastases, 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 5 inclusion and 7 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 11 Mar 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 Guoxiang Cai, M.D. Ph.D. (+86 13611831623, gxcai@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 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 11 Mar 2019.