A 6 microRNA Tool for Stratifying Stage II Colon Cancer of Receiving Adjuvant Chemotherapy

Colonic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02466113
• Other study ID #: 2015[28]
• Status: Not yet recruiting
• Phase: N/A
• First received: April 30, 2015
• Last updated: June 8, 2015
• Start date: January 2016
• Est. completion date: January 2026

Study information

• Verified date: June 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: Interventional

Clinical Trial Summary

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.

Description:

Investigators randomly assign patients to be assessed by classical pathological features(control group) or the miRNA tool(experimental group). Pathological features include poorly differentiated histology(exclusive of those cancers that are MSI-H),lymphatic/vascular invasion,bowel obstruction and <12 lymph nodes examined.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). Investigators defined high risk patient if had any pathological features in control group or the score larger than 1 in the experimental group ,the others as low risk patient.The high risk group should receive adjuvant chemotherapy while the low risk group deserve observation. Primary endpoint is the disease free survival and overall survival.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 430
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Colonic Neoplasms
• Effects of Chemotherapy

Intervention

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 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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		3 years or 5 years	Yes
Secondary	Overall survival		5 years or 10 years	Yes