microRNAs Tool for Stratifying Stage II Colon Cancer | NCT02635087

Studies
microRNAs Tool for Stratifying Stage II Colon Cancer

NCT02635087

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Status

Unknown status

Last Update Posted

Dec 30, 2015Estimated

Enrollment

630Estimated

Phase

Not provided

Conditions

Colonic Neoplasms
Effects of Chemotherapy

Interventions

miRNA tool

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Jul 2020Estimated

Completion Date

Jul 2025Estimated

First Submitted Date

Dec 16, 2015

First Submission Date that Met QC Criteria

Dec 17, 2015

First Posted Date

Dec 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2015

Last Update Posted Date

Dec 30, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wu Song, archiater, First Affiliated Hospital, Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital, Sun Yat-Sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

630Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high risk group		the miRNA tool predict this group of patients as "high risk"	Device: miRNA tool

Interventions

Name	Type	Description	Arm Group Labels	Other Names
miRNA tool	Device	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.

Measure	Description	Time Frame
DFS		3 years

Measure	Description	Time Frame
OS		5 years

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

The patients who had stage II colon cancer and received surgery.They agree to use miRNA tool to test their postoperative specimen.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zehong Chen, master	Contact	+8613751773229		Stevenchen8@qq.com

Overall Officials

Name	Affiliation	Role
Wu Song, MD	First Affiliated Hospital, Sun Yat-Sen University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
FisrtSunYetsen	Recruiting	Guangzhou	Guangdong	510000	China

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

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