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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
Sponsor:
Collaborators:
Sun Yat-sen University
Third Affiliated Hospital, Sun Yat-Sen University
Sixth Affiliated Hospital, Sun Yat-sen University
Information provided by (Responsible Party):
Wu Song, First Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment Phase
Colonic Neoplasms Effects of Chemotherapy Other: A 6 microRNA stratified tool Other: A classic stratified tool Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 3 years or 5 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years or 10 years ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466113


Contacts
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Contact: Zehong Chen, master +8613751773229 stevenchen8@qq.com

Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University
Third Affiliated Hospital, Sun Yat-Sen University
Sixth Affiliated Hospital, Sun Yat-sen University
Investigators
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Study Director: Wu Song, MD First Affiliated Hospital, Sun Yat-Sen University

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Responsible Party: Wu Song, Archiater, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02466113     History of Changes
Other Study ID Numbers: 2015[28]
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: June 9, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases