CClinicalTrials.gg
CompletedNCT03485196Updated Aug 10, 2022

The Relationship Between Microsatellite Instability and Efficacy of Fluorouracil Based Adjuvant Chemotherapy in Gastric Cancer After Operation

An observational study in Gastric Cancer, sponsored by Affiliated Hospital of Qinghai University. Completed at 3 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-10.

Sponsored by Affiliated Hospital of Qinghai University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Gastric Cancer

Keywords

  • Microsatellite Instability
  • Fluorouracil
  • Adjuvant chemotherapy
  • Efficacy
  • Operation
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

gastric cancer

Inclusion criteria

  1. Histopathology or cytopathology proven gastric cancer;
  2. Operable advanced gastric cancer patients: primary lesions can be completely excision, no distant metastasis;
  3. Postoperative patients who can tolerate 5-FU based (5-FU,S-1 or Capecitabine) adjuvant chemotherapy;
  4. Life expectancy of at least 6 months;
  5. ECOG(Eastern Cooperative Oncology Group ) score 0-1;
  6. Age: 18\~80 years old;
  7. 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;
  8. Roughly normal cardiopulmonary function: No coronary heart disease, myocardial infarction, pulmonary heart disease, refractory hypertension;
  9. Not concomitant with other uncontrollable benign diseases before the recruitment;
  1. Voluntarily signed the informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Advanced gastric cancer patients with distant metastasis and inoperable ;
  2. Patients who cannot tolerate 5-FU based adjuvant chemotherapy;
  3. Pregnant or lactating women;
  4. Patients who have no desire to participate in the study.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (actual)
Patient registry
No

Groups and cohorts

  • 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).

    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).

    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).

    Other: Microsatellite instability

Interventions

  • OtherMicrosatellite instability

    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.

05

What researchers measure

Primary outcomes

  1. Disease Free Survival

    The time from the primary operation to disease recurrence or death.

    Time frame: 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.

    Time frame: 5 years

06

Study locations

3 sites
  • The Second Hospital Affiliated to Lanzhou University
    Lanzhou, Gansu, China
  • Qinghai University Affiliated Hospital
    Xining, Qinghai 810000, China
  • People's Hospital of Qinghai Province
    Xining, Qinghai, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03485196
Lead sponsor
Affiliated Hospital of Qinghai University
Collaborators
Qinghai People's Hospital, LanZhou University
Responsible party
Jiuda Zhao (Professor, Affiliated Hospital of Qinghai University) — Principal investigator
First posted
Apr 2, 2018
Start date
Mar 1, 2017
Primary completion
Apr 1, 2021
Completion
Apr 1, 2021
Last update
Aug 10, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion