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

NCT ID: NCT02466113

Last Updated: 2015-06-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2026-01-31

Brief 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.

Detailed 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.

Conditions

Colonic Neoplasms; Effects of Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

A 6 microRNA stratified tool

Intervention Type: OTHER

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.

Group Type: OTHER

A classic stratified tool

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Wu Song

Archiater

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wu Song, MD

Role: STUDY_DIRECTOR

First Affiliated Hospital, Sun Yat-Sen University

Central Contacts

Zehong Chen, master

Role: CONTACT

stevenchen8@qq.com

+8613751773229

Other Identifiers

2015[28]

Identifier Type: -

Identifier Source: org_study_id