The Clinical Outcome and the Exploration of Related Bioma... | NCT02523495

Studies
The Clinical Outcome and the Exploration of Related Biomarkers of Target Therapy in Metastasis Colorectal Cancer

NCT02523495

Sponsor

Huazhong University of Science and Technology

Status

Unknown status

Last Update Posted

Aug 7, 2018Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Neoplasms, Therapy-Associated

Interventions

Not provided

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

Aug 2018

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

Jun 2012

Primary Completion Date

Jul 2020Estimated

Completion Date

Jul 2022Estimated

First Submitted Date

Aug 4, 2015

First Submission Date that Met QC Criteria

Aug 12, 2015

First Posted Date

Aug 14, 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

Aug 5, 2018

Last Update Posted Date

Aug 7, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xianglin Yuan, Professor, Chief physician, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Huazhong University of Science and TechnologyOTHER

Collaborators

Not provided

Description Module

Brief Summary

Through clinical observation and data statistics, conclude the clinical outcome of target therapy in metastasis colorectal cancer and explore some biomarkers that relate to target therapy.

Detailed Description

Establish a clinical database of patients who are diagnosed with metastasis colorectal cancer in tongji hospital.
Build a biological specimen banks of metastasis colorectal cancer through collecting blood samples from those patients who have reached an agreement with us.
Through clinical observation and data statistics, conclude the clinical outcome of target therapy in metastasis colorectal cancer.
To extract DNA from the blood and explore some biomarkers that related to target therapy in metastasis colorectal cancer.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Estimated

Measure	Description	Time Frame
overall survival		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Metastasis colorectal cancer confirmed by histologically and radiography
Receive target therapy over half a year
Have a measurable lesions

Exclusion Criteria:

1. A history of other malignant tumors in five years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Metastasis colorectal cancer patients in Chinese Han population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuan Xianglin, Professional	Contact	13667241722		yxl@medmail.com.cn
Zhao Ben, Master	Contact	15071206621		zhaoben0609@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Huazhong University of Science and Technology	Recruiting	Wuhan	Hubei	430000	China