- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02554448
Detection of CTCs in Stage III Rectal Cancer Patients Undergoing Neoadjuvant Therapy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yanxin Luo, PhD
- Phone Number: +86-13826190263
- Email: luoyx25@mail.sysu.edu.cn
Study Contact Backup
- Name: Weida Lin, master
- Phone Number: +86-13430354015
- Email: linweida529@163.com
Study Locations
-
-
Guangdong
-
GuangZhou, Guangdong, China
- Recruiting
- The Sixth Affiliate Hospital of Sun Yat-Sen University
-
Contact:
- Yanxin Luo, PhD
- Phone Number: +86-13826190263
- Email: luoyx25@mail.sysu.edu.cn
-
Contact:
- Weida Lin, master
- Phone Number: +86-13430354015
- Email: linweida529@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Circulating Tumor Cells
Use ISET system to test the number of CTCs from patients before and during treatment.
|
Use ISET system to test the number of CTCs from patients before and during treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of Circulating Tumor Cells (CTCs)
Time Frame: 6 month
|
6 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yanxin Luo, PhD, Sixth Affiliated Hospital, Sun Yat-sen University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Processes
- Colorectal Neoplasms
- Neoplasm Metastasis
- Rectal Neoplasms
- Neoplastic Cells, Circulating
Other Study ID Numbers
- CTC-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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