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
Sponsor study identifier
interventional
430
0 countries
N/A
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Whether patients with stage II colon cancer should receive adjuvant chemotherapy or not is still on debate.MicroRNA(miRNA) is a promising tool. Investigators invented a tool consisting of 6 miRNA(miR-21、miR-20a-5p、miR-103a-3p、miR-106b-5p、miR-143-5p and miR-215) that was effective to identify one should accept adjuvant chemotherapy or not. Here investigators randomly assign patients to be assessed by classical pathological features or the miRNA tool of determining who should accept chemotherapy. Disease free survival and overall survival are the end points of observation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2026
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 30, 2015
Actual (reported)June 9, 2015
Actual (reported)January 2016
Date type not reportedThis date has not been verified as actual or estimated.
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Disease free survival
3 years or 5 years
Overall survival
5 years or 10 years
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.
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.
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.
Wu Song, MD
First Affiliated Hospital, Sun Yat-Sen University
First Submitted
April 30, 2015
First Posted
June 9, 2015
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2026
Estimated (date passed)Endoscopic Ultrasound and Contrast Enhancement for Staging and Evaluation of Angiogenesis of Left Sided Colon Cancers
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.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 9, 2015
Record last verified: 2015-06
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