Detection of CTCs in Stage III Rectal Cancer Patients Undergoing Neoadjuvant Therapy
Primary Purpose
Rectal Neoplasms, Circulating Tumor Cells
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ISET system
Sponsored by
About this trial
This is an interventional screening trial for Rectal Neoplasms focused on measuring Circulating Tumor Cells, rectal Neoplasms, neoadjuvant otherapy
Eligibility Criteria
Inclusion Criteria:
- Age: >18 years old.
- Diagnosis of stage III rectal cancer based on histology.
- Will receive neoadjuvant treatment using Folfox or chemoradiotherapy .
- Life expectancy: Greater than 3 months.
- Patients have no severe inflammation, such as vasculitis.
- Ability to understand the study protocol and a willingness to sign a written informed consent document
Exclusion Criteria:
- Patients with other primary tumor except rectal cancer.
- History of coagulation disorders or anemia.
Sites / Locations
- The Sixth Affiliate Hospital of Sun Yat-Sen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Circulating Tumor Cells
Arm Description
Use ISET system to test the number of CTCs from patients before and during treatment.
Outcomes
Primary Outcome Measures
The number of Circulating Tumor Cells (CTCs)
Secondary Outcome Measures
Full Information
NCT ID
NCT02554448
First Posted
September 17, 2015
Last Updated
May 28, 2016
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02554448
Brief Title
Detection of CTCs in Stage III Rectal Cancer Patients Undergoing Neoadjuvant Therapy
Official Title
Detection of CTCs in Stage III Rectal Cancer Patients Undergoing Neoadjuvant Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the value of dynamic change in detecting CTCs in peripheral blood from stage III rectal cancer patients undergoing neoadjuvant Folfox treatment and chemoradiotherapy,before and after surgery.
Detailed Description
Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. Enumeration of CTCs in rectal cancer patients could play an important role in diagnosis, predicting the risk for tumor recurrence and effectiveness of neoadjuvant therapy.
The investigators choose several timepoints to detect the dynamic change of CTCs,1 day before the 1st ,3rd and 5th(if the patient needs before surgery) neoadjuvant therapy course,1 day before and 7days ,3 month,6 month after surgery. Approximately 7.5-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients with rectal cancer . Briefly, the number of CTCs will be count by the cellsearch system , recorded and analysed by the investigator.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms, Circulating Tumor Cells
Keywords
Circulating Tumor Cells, rectal Neoplasms, neoadjuvant otherapy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Circulating Tumor Cells
Arm Type
Experimental
Arm Description
Use ISET system to test the number of CTCs from patients before and during treatment.
Intervention Type
Other
Intervention Name(s)
ISET system
Intervention Description
Use ISET system to test the number of CTCs from patients before and during treatment.
Primary Outcome Measure Information:
Title
The number of Circulating Tumor Cells (CTCs)
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: >18 years old.
Diagnosis of stage III rectal cancer based on histology.
Will receive neoadjuvant treatment using Folfox or chemoradiotherapy .
Life expectancy: Greater than 3 months.
Patients have no severe inflammation, such as vasculitis.
Ability to understand the study protocol and a willingness to sign a written informed consent document
Exclusion Criteria:
Patients with other primary tumor except rectal cancer.
History of coagulation disorders or anemia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanxin Luo, PhD
Phone
+86-13826190263
Email
luoyx25@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Weida Lin, master
Phone
+86-13430354015
Email
linweida529@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanxin Luo, PhD
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sixth Affiliate Hospital of Sun Yat-Sen University
City
GuangZhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanxin Luo, PhD
Phone
+86-13826190263
Email
luoyx25@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Weida Lin, master
Phone
+86-13430354015
Email
linweida529@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
not ready to share the data
Learn more about this trial
Detection of CTCs in Stage III Rectal Cancer Patients Undergoing Neoadjuvant Therapy
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