Detection of CTCs in Stage III Rectal Cancer Patients Undergoing Neoadjuvant Therapy

Rectal Neoplasms Clinical Trial

Official title:

Detection of CTCs in Stage III Rectal Cancer Patients Undergoing Neoadjuvant Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02554448
• Other study ID #: CTC-1
• Status: Recruiting
• Phase: N/A
• First received: September 17, 2015
• Last updated: May 28, 2016
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: April 2016
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Yanxin Luo, PhD
• Phone: +86-13826190263
• Email: luoyx25[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age: >18 years old.

2. Diagnosis of stage III rectal cancer based on histology.

3. Will receive neoadjuvant treatment using Folfox or chemoradiotherapy .

4. Life expectancy: Greater than 3 months.

5. Patients have no severe inflammation, such as vasculitis.

6. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except rectal cancer.

2. History of coagulation disorders or anemia.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Circulating Tumor Cells
• Neoplastic Cells, Circulating
• Rectal Neoplasms

Intervention

Other:
• ISET system
Use ISET system to test the number of CTCs from patients before and during treatment.

Locations

Country	Name	City	State
China	The Sixth Affiliate Hospital of Sun Yat-Sen University	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of Circulating Tumor Cells (CTCs)		6 month	Yes