Colorectal NeoplasmsNCT03561350
Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing
An observational study of Colorectal Neoplasms, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
Trial summary
The method to analyze the microsatellite instability (MSI) status by next-generation sequencing (NGS) has been established to assess the deficiency of DNA mismatch repair (MMR) system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2017to Sep 2018
- 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 hospitalized in Shanghai Minimally Invasive Surgery Center
Who may be able to join
- a biopsy proven histological diagnosis of colorectal carcinoma
- MSI status of tissue sample known by IHC or PCR method
- willing to participate and informed consent signed
Who cannot join
- history of other malignant tumors
- patients with inflammatory bowel disease
- patients with familial adenomatous polyposis
- patients treated by surgery or adjuvant treatment
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Minimally Invasive Surgery Canter, Ruijin hospital
Shanghai, Shanghai Municipality, 200000
Zhenghai CAI, MD
About this study
The method to analyze the microsatellite instability (MSI) status by next-generation sequencing (NGS) has been established to assess the deficiency of DNA mismatch repair (MMR) system. The aim of our study is to evaluate the feasibility and reliability of this NGS method by testing the circulating tumor DNA (ctDNA) in blood sample of advanced colorectal cancer patients. If the result is positive, the MSI status could be easily learned without the acquisition of tissue samples.
- Conditions
- Colorectal Neoplasms
- Keywords
- Microsatellite Instability, Circulating Tumor DNA, Colorectal Neoplasms
- Medical subject headings
- Colorectal Neoplasms, Microsatellite Instability
What is being measured
The primary outcome is the main question the study is designed to answer.
MSI status in blood sample
ctDNA and leucocyte are extracted from blood sample for MSI detection by ColonCore NGS panel (Burning Rock, Guangzhou, China). There are three types of MSI status, MSI-H, MSI-L and MSS.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start28 Sep 2017
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561350
- Sponsor's protocol ID
- MISC-MSI
- Status last verified
- May 2018
- First submitted
- 25 May 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing
- ClinicalTrials.gov ID
- NCT03561350
- Acronym / sponsor ID
- MISC-MSI
- Conditions
- Colorectal Neoplasms
- Keywords
- Microsatellite Instability, Circulating Tumor DNA, Colorectal Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 19 Jun 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.
The method to analyze the microsatellite instability (MSI) status by next-generation sequencing (NGS) has been established to assess the deficiency of DNA mismatch repair (MMR) system. The aim of our study is to evaluate the feasibility and reliability of this NGS method by testing the circulating tumor DNA (ctDNA) in blood sample of advanced colorectal cancer patients. If the result is positive, the MSI status could be easily learned without the acquisition of tissue samples.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in Shanghai Minimally Invasive Surgery Center
Key inclusion criteria (3 listed)
- a biopsy proven histological diagnosis of colorectal carcinoma
- MSI status of tissue sample known by IHC or PCR method
- willing to participate and informed consent signed
Key exclusion criteria (5 listed)
- history of other malignant tumors
- patients with inflammatory bowel disease
- patients with familial adenomatous polyposis
- patients treated by surgery or adjuvant treatment
- pregnant or lactating women
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
MSI status in blood sample
Time frame: through study completion, an average of 1 year
ctDNA and leucocyte are extracted from blood sample for MSI detection by ColonCore NGS panel (Burning Rock, Guangzhou, China). There are three types of MSI status, MSI-H, MSI-L and MSS.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 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 Neoplasms, run by Shanghai Minimally Invasive Surgery Center 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 5 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 Jun 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?
Contact Zhenghao CAI (86-21-64458887, czh12005@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSI status in blood sample (time frame: through study completion, an average of 1 year). 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 Jun 2018.