Gastrointestinal CancerNCT03915171
Sensitivity and Specificity of NGS in Detecting bMSI in Patients With Gastric, Duodenal and Small Intestinal Cancer
A study testing Next generation sequencing in people with Gastrointestinal Cancer, run by China Medical University, China at 1 site in China.
Trial summary
To study the sensitivity and specificity of NGS in detecting Microsatellite State in blood and to evaluate its potential application in gastrointestinal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- Next generation sequencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 1 Jun 2020
- Phase
- Interventional
- 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
Who may be able to join
- Age (>18 years old).
- Histologically diagnosed as gastric cancer, duodenal cancer or small intestinal cancer (stage III, stage IV).
- The status of dMMR/pMMR was confirmed by IHC/PCR.
- with tissue and blood samples (including ctDNA and white blood cells) that meet the requirements.
- Agree to provide demographic, medical history, pathological diagnosis, imaging diagnosis, TNM staging, ECOG score and other information.
Who cannot join
- Suffering from other malignant tumors at the same time.
- Others that the investigator consider that is inappropriate for this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Yunpeng Liu, Ph.D
About this study
To study the sensitivity and specificity of NGS in detecting Microsatellite State in blood and to evaluate its potential application in gastrointestinal cancer.
Read the detailed description
NGS can not only detect tissue samples, but also blood samples. For some inoperable cancer patients, the acquisition of tissue samples is difficult and traumatic. It is of great significance for the diagnosis and treatment of these patients to determine MSI status by blood testing. In addition, the heterogeneity of malignant tumors is usually strong, blood testing can overcome the heterogeneity of tissue, and can dynamically monitor the patient's condition. 50 patients with gastric cancer, duodenal cancer and small intestinal cancer will be enrolled in the study. Among them, 30 patients with MSI-H and 20 patients with MSS confirmed by IHC/PCR.The investigators will use 520 gene panel for NGS sequencing of tissue and blood samples from selected patients to study the sensitivity and specificity of NGS in detecting Microsatellite State in blood.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Next generation sequencing
- Keywords
- NGS bMSI Gastrointestinal
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next generation sequencingDiagnostic test
NGS can provide genetic and MSI test for patients
| Study group | Role | What they receive |
|---|---|---|
| MSI-H | Experimental | IHC/PCR tested as dMMR/ MSI-H Receives: Diagnostic Test: Next generation sequencing |
| MSS | Experimental | IHC/PCR tested as pMMR/ MSS Receives: Diagnostic Test: Next generation sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of blood MSI detected by NGS
To study the sensitivity and specificity of blood MSI detected by NGS.
Measured: 1 year
Secondary outcomes (3)
Ideal sequencing depth of MSI in blood test
To study the ideal sequencing depth of MSI in blood test.
Measured: 1 year
Correlation between MSI status and TMB
To study the correlation between MSI status and TMB.
Measured: 1 year
Correlation between MMR gene and other gene mutations
To study thecorrelation between MMR gene and other gene mutations.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Mar 2019
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunpeng Liu, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915171
- Sponsor's protocol ID
- RSTL2018011
- Status last verified
- Apr 2019
- First submitted
- 25 Mar 2019
- Last updated
- 16 Apr 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 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity of NGS in Detecting bMSI in Patients With Gastric, Duodenal and Small Intestinal Cancer
- ClinicalTrials.gov ID
- NCT03915171
- Acronym / sponsor ID
- RSTL2018011
- Conditions
- Gastrointestinal Cancer
- Keywords
- NGS bMSI Gastrointestinal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 16 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.
To study the sensitivity and specificity of NGS in detecting Microsatellite State in blood and to evaluate its potential application in gastrointestinal cancer.
Detailed description
NGS can not only detect tissue samples, but also blood samples. For some inoperable cancer patients, the acquisition of tissue samples is difficult and traumatic. It is of great significance for the diagnosis and treatment of these patients to determine MSI status by blood testing. In addition, the heterogeneity of malignant tumors is usually strong, blood testing can overcome the heterogeneity of tissue, and can dynamically monitor the patient's condition. 50 patients with gastric cancer, duodenal cancer and small intestinal cancer will be enrolled in the study. Among them, 30 patients with MSI-H and 20 patients with MSS confirmed by IHC/PCR.The investigators will use 520 gene panel for NGS sequencing of tissue and blood samples from selected patients to study the sensitivity and specificity of NGS in detecting Microsatellite State in blood.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSI-H | Experimental | Diagnostic Test: Next generation sequencingIHC/PCR tested as dMMR/ MSI-H |
| MSS | Experimental | Diagnostic Test: Next generation sequencingIHC/PCR tested as pMMR/ MSS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age (>18 years old).
- Histologically diagnosed as gastric cancer, duodenal cancer or small intestinal cancer (stage III, stage IV).
- The status of dMMR/pMMR was confirmed by IHC/PCR.
- with tissue and blood samples (including ctDNA and white blood cells) that meet the requirements.
- Agree to provide demographic, medical history, pathological diagnosis, imaging diagnosis, TNM staging, ECOG score and other information.
Key exclusion criteria (2 listed)
- Suffering from other malignant tumors at the same time.
- Others that the investigator consider that is inappropriate for this study.
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 sequencingNGS can provide genetic and MSI test for patients | Diagnostic test | MSI-H, MSS |
Primary outcome
Sensitivity and specificity of blood MSI detected by NGS
Time frame: 1 year
To study the sensitivity and specificity of blood MSI detected by NGS.
3 secondary outcomes
Ideal sequencing depth of MSI in blood test
Time frame: 1 year
Correlation between MSI status and TMB
Time frame: 1 year
Correlation between MMR gene and other gene mutations
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 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?
A study testing Next generation sequencing in people with Gastrointestinal Cancer, run by China Medical University, China 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 2 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 16 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 Yunpeng Liu, ph.D (＋86(0)24 961200, cmuliuyunpeng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of blood MSI detected by NGS (time frame: 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 16 Apr 2019.