Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

microRNAs Tool for Stratifying Stage II Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02635087
Recruitment Status : Recruiting
First Posted : December 18, 2015
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):
Wu Song, First Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
The investigators discover the investigators' miRNA tool can be a useful tool to predict the patients with stage II colon who can benefit from chemotherapy.Then the investigators plan to make an observation study that may validation this tool.

Condition or disease Intervention/treatment
Colonic Neoplasms Effects of Chemotherapy Device: miRNA tool

Detailed Description:
This is an observation study. The investigators recruit patients who agree to use their postoperative specimen for miRNA tool examination and receive the investigators' follow up.Their receiving chemotherapy or not will decided by their doctors. The investigators just see whether the stratifying tool could predict prognosis.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 630 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: microRNAs Tool for Stratifying Stage II Colon Cancer:a Perspective Study of Adjuvant Chemotherapy
Study Start Date : December 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2025

Group/Cohort Intervention/treatment
high risk group
the miRNA tool predict this group of patients as "high risk"
Device: miRNA tool
patients to be assessed by the miRNA tool. 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.Then we determine the patients who with a score higher than 1 as exposed patient.




Primary Outcome Measures :
  1. DFS [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. OS [ Time Frame: 5 years ]

Biospecimen Retention:   Samples Without DNA
We will use the samples to make q-RT-PCR of our miRNA tool,then predict the patients as high risk one or not.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients who had stage II colon cancer and received surgery.They agree to use miRNA tool to test their postoperative specimen.
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): NCT02635087


Contacts
Layout table for location contacts
Contact: Zehong Chen, master +8613751773229 Stevenchen8@qq.com

Locations
Layout table for location information
China, Guangdong
FisrtSunYetsen Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Zehong Chen, master    8613751773229    stevenchen8@qq.com   
Contact: Wu Song, doctor    8613751773229    songwu@mail.sysu.com   
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
Layout table for investigator information
Study Director: Wu Song, MD First Affiliated Hospital, Sun Yat-Sen University

Layout table for additonal information
Responsible Party: Wu Song, archiater, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02635087     History of Changes
Other Study ID Numbers: 2015[112]
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015

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