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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02554448

Enrollment

Registered

2015-09-18

Start date

2016-01-31

Completion date

2016-12-31

Last updated

2016-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulating Tumor Cells, Rectal Neoplasms

Keywords

Circulating Tumor Cells, rectal Neoplasms, neoadjuvant otherapy

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.

Interventions

OTHERISET system

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
The number of Circulating Tumor Cells (CTCs)	6 month

Countries

China

Contacts

Primary ContactYanxin Luo, PhD

luoyx25@mail.sysu.edu.cn+86-13826190263

Backup ContactWeida Lin, master

linweida529@163.com+86-13430354015

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026