Colonic Neoplasms, Effects of Chemotherapy
Conditions
Brief summary
The investigators discover the investigators' miRNA tool can be a useful tool to predict the patients with stage II colon who can benefit from chemotherapy.Then the investigators plan to make an observation study that may validation this tool.
Detailed description
This is an observation study. The investigators recruit patients who agree to use their postoperative specimen for miRNA tool examination and receive the investigators' follow up.Their receiving chemotherapy or not will decided by their doctors. The investigators just see whether the stratifying tool could predict prognosis.
Interventions
DEVICEmiRNA tool
patients to be assessed by the miRNA tool. MicroRNA tool contains miRNA of miR-21、miR-20a-5p、miR-103a-3p、miR-106b-5p、miR-143-5p and miR-215. Investigators evaluate these miRNA status of surgical specimens using qRT-PCR and calculate their risk score(risk score =(0.108×status of miR-21-5p)+(0.086×status of miR-20a-5p)+(0.240×status of miR-103a-3p)+(0.095×status of miR-106b-5p)- (0.238×status of miR-143-5p)-(0.237×status of miR-215),low expression status equals 0 and high expression status equals 1.Then we determine the patients who with a score higher than 1 as exposed patient.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The informed consent has been obtained from the patient. * With confirmed diagnosis of stage II colon cancer. * With moderate/good ECOG health rating (PS): 0-1 score. * The patient receive no anti-cancer treatment before primary surgery. * The patient receive radical operation for colon cancer with negative margin.
Exclusion criteria
* With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction. * With bad compliance or contraindication to enrollment. * Pregnant woman or lactating woman. * With contraindication to receive adjuvant chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| OS | 5 years |
Countries
China
Contacts
Primary ContactZehong Chen, master
Outcome results
None listed