Gastric CancerNCT03485196
The Relationship Between Microsatellite Instability and Efficacy of Fluorouracil Based Adjuvant Chemotherapy in Gastric Cancer After Operation
An observational study of Gastric Cancer, run by Affiliated Hospital of Qinghai University at 3 sites in China.
Trial summary
The relationship between Microsatellite instability and efficacy of fluorouracil based adjuvant chemotherapy in gastric cancer after operation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Microsatellite instability
- How many people
- 1,000 participants
- Where
- 3 sitesChina
- Study dates
- 1 Mar 2017to 1 Apr 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: gastric cancer
Who may be able to join
- Histopathology or cytopathology proven gastric cancer;
- Operable advanced gastric cancer patients: primary lesions can be completely excision, no distant metastasis;
- Postoperative patients who can tolerate 5-FU based (5-FU，S-1 or Capecitabine) adjuvant chemotherapy;
- Life expectancy of at least 6 months;
- ECOG（Eastern Cooperative Oncology Group ） score 0-1;
- Age: 18~80 years old;
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- Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function).
- For example: WBC（White blood cell count ）>4.0×109/L; NEU（Neutrophils）>1.5×109/L; PLT（Platelet）>100×109/L;
- Roughly normal cardiopulmonary function: No coronary heart disease, myocardial infarction, pulmonary heart disease, refractory hypertension;
- Not concomitant with other uncontrollable benign diseases before the recruitment;
- 9. Voluntarily signed the informed consent.
Who cannot join
- Advanced gastric cancer patients with distant metastasis and inoperable ;
- Patients who cannot tolerate 5-FU based adjuvant chemotherapy;
- Pregnant or lactating women;
- Patients who have no desire to participate in the study.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Second Hospital Affiliated to Lanzhou University
Lanzhou, Gansu
Qinghai University Affiliated Hospital
Xining, Qinghai, 810000
People's Hospital of Qinghai Province
Xining, Qinghai
About this study
The relationship between Microsatellite instability and efficacy of fluorouracil based adjuvant chemotherapy in gastric cancer after operation.
Read the detailed description
To explore the relationship between Microsatellite instability and efficacy of fluorouracil based adjuvant chemotherapy in gastric cancer after operation.
- Conditions
- Gastric Cancer
- Being tested
- Microsatellite instability
- Keywords
- Microsatellite Instability, Fluorouracil, Adjuvant chemotherapy, Efficacy, Operation
- Medical subject headings
- Stomach Neoplasms, Microsatellite Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microsatellite instabilityOther
The microsatellite instability status are definite to three type:MSI-H, MSI-L,and MSS. The gastric cancer patients who received D2 resection were included in 3 groups：MSI-H group， MSI-L group，and MSS group. All patient must be accept fluorouracil(5-FU) based adjuvant chemotherapy. We will analyze the relationship between MSI status and efficacy of 5-FU based adjuvant chemotherapy by observing the survival period of patients with different MSI status.
| Study group | Role | What they receive |
|---|---|---|
| MSI-H group | We use the immunohistochemical expression of mismatch repair proteins (MutS protein homolog 2( MSH2),MutS protein homolog 6( MSH6) and PMS2（postmeiotic segregation increased 2 ）) to Determine the MSI status . When one antibodies or more show negative nuclear staining of the tumor cells, the MSI state can be defined as Microsatellite instability high (MSI-H). Receives: Other: Microsatellite instability | |
| MSI-L group | We use the immunohistochemical expression of mismatch repair proteins (MLH1, MSH2, MSH6 and PMS2) to Determine the MSI status . when all the four antibodies show positive nuclear staining of the tumor cells, the MSI state can be defined as Microsatellite stable (MSI-L). Receives: Other: Microsatellite instability | |
| MSS group | We use the immunohistochemical expression of mismatch repair proteins (MLH1, MSH2, MSH6 and PMS2) to Determine the MSI status . when all the four antibodies show positive nuclear staining of the tumor cells, the MSI state can be defined as Microsatellite stable (MSS). Receives: Other: Microsatellite instability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival
The time from the primary operation to disease recurrence or death.
Measured: 5 years
Secondary outcomes (1)
Overall survival(OS)
The The time from operation to death or the last follow-up. The time from operation to death or the last follow-up.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start1 Mar 2017
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Qinghai University
- Sponsor type
- University, hospital or other
- Collaborators
- Qinghai People's Hospital, LanZhou University
- Responsible party
- Principal investigator, Jiuda Zhao, Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485196
- Sponsor's protocol ID
- AHQU-2017003
- Status last verified
- Aug 2022
- First submitted
- 25 Mar 2018
- Last updated
- 10 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Microsatellite Instability and Efficacy of Fluorouracil Based Adjuvant Chemotherapy in Gastric Cancer After Operation
- ClinicalTrials.gov ID
- NCT03485196
- Acronym / sponsor ID
- AHQU-2017003
- Conditions
- Gastric Cancer
- Keywords
- Microsatellite Instability, Fluorouracil, Adjuvant chemotherapy, Efficacy, Operation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Affiliated Hospital of Qinghai UniversityUniversity, hospital or other
- Collaborators
- Qinghai People's Hospital, LanZhou University
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 2 Apr 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 relationship between Microsatellite instability and efficacy of fluorouracil based adjuvant chemotherapy in gastric cancer after operation.
Detailed description
To explore the relationship between Microsatellite instability and efficacy of fluorouracil based adjuvant chemotherapy in gastric cancer after operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MSI-H group | – | Other: Microsatellite instabilityWe use the immunohistochemical expression of mismatch repair proteins (MutS protein homolog 2( MSH2),MutS protein homolog 6( MSH6) and PMS2（postmeiotic segregation increased 2 ）) to Determine the MSI status . When one antibodies or more show negative nuclear staining of the tumor cells, the MSI state can be defined as Microsatellite instability high (MSI-H). |
| MSI-L group | – | Other: Microsatellite instabilityWe use the immunohistochemical expression of mismatch repair proteins (MLH1, MSH2, MSH6 and PMS2) to Determine the MSI status . when all the four antibodies show positive nuclear staining of the tumor cells, the MSI state can be defined as Microsatellite stable (MSI-L). |
| MSS group | – | Other: Microsatellite instabilityWe use the immunohistochemical expression of mismatch repair proteins (MLH1, MSH2, MSH6 and PMS2) to Determine the MSI status . when all the four antibodies show positive nuclear staining of the tumor cells, the MSI state can be defined as Microsatellite stable (MSS). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- gastric cancer
Key inclusion criteria (11 listed)
- Histopathology or cytopathology proven gastric cancer;
- Operable advanced gastric cancer patients: primary lesions can be completely excision, no distant metastasis;
- Postoperative patients who can tolerate 5-FU based (5-FU，S-1 or Capecitabine) adjuvant chemotherapy;
- Life expectancy of at least 6 months;
- ECOG（Eastern Cooperative Oncology Group ） score 0-1;
Key exclusion criteria (4 listed)
- Advanced gastric cancer patients with distant metastasis and inoperable ;
- Patients who cannot tolerate 5-FU based adjuvant chemotherapy;
- Pregnant or lactating women;
- Patients who have no desire to participate in the 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 |
|---|---|---|
| Microsatellite instabilityThe microsatellite instability status are definite to three type:MSI-H, MSI-L,and MSS. The gastric cancer patients who received D2 resection were included in 3 groups：MSI-H group， MSI-L group，and MSS group. All patient must be accept fluorouracil(5-FU) based adjuvant chemotherapy. We will analyze the relationship between MSI status and efficacy of 5-FU based adjuvant chemotherapy by observing the survival period of patients with different MSI status. | Other | MSI-H group, MSI-L group, MSS group |
Primary outcome
Disease Free Survival
Time frame: 5 years
The time from the primary operation to disease recurrence or death.
1 secondary outcome
Overall survival(OS)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Affiliated Hospital of Qinghai University at 3 sites 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 11 inclusion and 4 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: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (time frame: 5 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 10 Aug 2022.