microRNAs Tool for Stratifying Stage II Colon Cancer

Sun Yat-sen University

Status: Enrolling

Conditions: Colonic Neoplasms; Effects of Chemotherapy

Treatments: Device: miRNA tool

Study type: Observational

Funder types: Other

Identifiers

NCT02635087

2015[112]

Details and patient eligibility

About

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.

Full 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.

Enrollment: 630 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

630 participants in 1 patient group

high risk group

Description:

the miRNA tool predict this group of patients as "high risk"

Treatment:

Device: miRNA tool