microRNAs Tool for Stratifying Stage II Colon Cancer

Colonic Neoplasms Clinical Trial

Official title:

microRNAs Tool for Stratifying Stage II Colon Cancer:a Perspective Study of Adjuvant Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02635087
• Other study ID #: 2015[112]
• Status: Recruiting
• Phase: N/A
• First received: December 16, 2015
• Last updated: December 29, 2015
• Start date: December 2015
• Est. completion date: July 2025

Study information

• Verified date: December 2015
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Zehong Chen, master
• Phone: +8613751773229
• Email: Stevenchen8[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 630
• Est. completion date: July 2025
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Neoplasms
• Effects of Chemotherapy

Intervention

Device:
• miRNA 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.

Locations

Country	Name	City	State
China	FisrtSunYetsen	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS		3 years	No
Secondary	OS		5 years	No