Detection of CTCs in Stage III Rectal Cancer Patients Undergoing Neoadjuvant Therapy
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2015
CompletedFirst Posted
Study publicly available on registry
September 18, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 1, 2016
April 1, 2016
9 months
September 17, 2015
May 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of Circulating Tumor Cells (CTCs)
6 month
Study Arms (1)
Circulating Tumor Cells
EXPERIMENTALUse ISET system to test the number of CTCs from patients before and during treatment.
Interventions
Use ISET system to test the number of CTCs from patients before and during treatment.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with other primary tumor except rectal cancer.
- History of coagulation disorders or anemia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Sixth Affiliate Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanxin Luo, PhD
Sixth Affiliated Hospital, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2015
First Posted
September 18, 2015
Study Start
January 1, 2016
Primary Completion
October 1, 2016
Study Completion
December 1, 2016
Last Updated
June 1, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share
not ready to share the data