A 6 microRNA Tool for Stratifying Stage II Colon Cancer of Receiving Adjuvant Chemotherapy
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|ClinicalTrials.gov Identifier: NCT02466113|
Recruitment Status : Not yet recruiting
First Posted : June 9, 2015
Last Update Posted : June 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Colonic Neoplasms Effects of Chemotherapy||Other: A 6 microRNA stratified tool Other: A classic stratified tool||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||430 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-site, Open, Perspective Study of Prognostic Value and Benefit From Chemotherapy of Stage II Colon Cancer Based on a 6 microRNA Stratified Tool|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||January 2026|
|Estimated Study Completion Date :||January 2026|
Experimental: An experimental group
A 6 microRNA stratified tool is applied in this group.Investigators defined high risk patient and low risk patient according to the microRNA stratified tool.The high risk group should receive adjuvant chemotherapy while the low risk group observation.
Other: A 6 microRNA stratified tool
Investigators randomly assign patients to be assessed by a 6 microRNA stratified tool. MicroRNA(miRNA) 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 miRNA-21-5p)+(0.086×status of miRNA-20a-5p)+(0.240×status of miRNA-103a-3p)+(0.095×status of miRNA-106b-5p)-(0.238×status of miRNA-143-5p)-(0.237×status of miRNA-215),low expression status equals 0 and high expression status equals 1). Investigators defined high risk patient if their score larger than 1, the others as low risk patient.The high risk group should receive adjuvant chemotherapy while the low risk group deserve observation.
A control group
A classic stratified tool is applied in this group. Investigators defined high risk and low risk patient according to classical pathological features.The high risk group should receive adjuvant chemotherapy while the low risk group observation.
Other: A classic stratified tool
Investigators randomly assign patients to be assessed by by classical pathological features. Pathological features include poorly differentiated histology(exclusive of those cancers that are MSI-H),lymphatic/vascular invasion,bowel obstruction and <12 lymph nodes examined. Investigators defined high risk patient if they had any pathological features, the others as low risk patient. The high risk group should receive adjuvant chemotherapy while the low risk group deserve observation.
- Disease free survival [ Time Frame: 3 years or 5 years ]
- Overall survival [ Time Frame: 5 years or 10 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466113
|Contact: Zehong Chen, firstname.lastname@example.org|
|Study Director:||Wu Song, MD||First Affiliated Hospital, Sun Yat-Sen University|