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

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02466113

Enrollment

430

Registered

2015-06-09

Start date

2016-01-31

Completion date

2026-01-31

Last updated

2015-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Neoplasms, Effects of Chemotherapy

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.

Interventions

OTHERA 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.

OTHERA 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Disease free survival	3 years or 5 years

Secondary

Measure	Time frame
Overall survival	5 years or 10 years

Contacts

Primary ContactZehong Chen, master

stevenchen8@qq.com+8613751773229

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026