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

NCT ID: NCT02554448

Last Updated: 2016-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Rectal Neoplasms Circulating Tumor Cells

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Circulating Tumor Cells

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

Group Type EXPERIMENTAL

ISET system

Intervention Type OTHER

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

Interventions

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ISET system

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yanxin Luo, PhD

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Locations

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The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanxin Luo, PhD

Role: CONTACT

+86-13826190263

Weida Lin, master

Role: CONTACT

+86-13430354015

Facility Contacts

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Yanxin Luo, PhD

Role: primary

+86-13826190263

Weida Lin, master

Role: backup

+86-13430354015

Other Identifiers

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CTC-1

Identifier Type: -

Identifier Source: org_study_id

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