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

NCT03485196 | Completed

• 1 other identifier: AHQU-2017003
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

Brief Summary

The relationship between Microsatellite instability and efficacy of fluorouracil based adjuvant chemotherapy in gastric cancer after operation.

Conditions

Gastric Cancer

Keywords

Microsatellite Instability; Fluorouracil; Adjuvant chemotherapy; Efficacy; Operation

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival

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

  5 years

Secondary Outcomes (1)

• Overall survival(OS)

  5 years

Study Arms (3)

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

Microsatellite instability OTHER

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.

MSI-H group; MSI-L group; MSS group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

gastric cancer

You may qualify if:

• 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;
• 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;
• \. Voluntarily signed the informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Qinghai University: lead
• Qinghai People's Hospital: collaborator
• LanZhou University: collaborator

Study Sites (3)

The Second Hospital Affiliated to Lanzhou University

Lanzhou, Gansu, China

Location

Qinghai University Affiliated Hospital

Xining, Qinghai, 810000, China

Location

People's Hospital of Qinghai Province

Xining, Qinghai, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Microsatellite Instability

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Genomic Instability; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2018
• First Posted: April 2, 2018
• Study Start: March 1, 2017
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)