Back to resultsCTC Detection Rate in SCCHN With a in Vivo Device
Primary Purpose
Circulating Tumor Cell, Squamous Cell Carcinoma of the Head and Neck
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
circulating tumor cell analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Circulating Tumor Cell
Eligibility Criteria
Inclusion Criteria:
- SCCHN confirmed with clinical examination
- Have agreed to undergo CTC analysis in vivo;
- ECOG：0-2
Exclusion Criteria:
- the other cancer types
Sites / Locations
- Nanjing Tongren HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SCCHN
Control
Arm Description
squamous cell carcinoma of the head and neck
health volunteers
Outcomes
Primary Outcome Measures
CTC isolation
Isolate circulating tumor cells in vivo with CellCollector
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03071900
Brief Title
CTC Detection Rate in SCCHN With a in Vivo Device
Official Title
Enumeration and Molecular Characterization of Circulating Tumor Cells (CTCs) Using a in Vivo Device in Squamous Cell Carcinoma of Head and Neck (SCCHN)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 22, 2016 (Actual)
Primary Completion Date
March 15, 2017 (Anticipated)
Study Completion Date
April 20, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing Tongren Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Detection rate and isolation yield of CTC is low in squamous cell carcinoma of head and neck (SCCHN) with in vitro approaches rely on limited sample volumes. In this study, we applied a new method, the CellCollector, which could capture CTC in vivo from peripheral blood.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circulating Tumor Cell, Squamous Cell Carcinoma of the Head and Neck
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SCCHN
Arm Type
Experimental
Arm Description
squamous cell carcinoma of the head and neck
Arm Title
Control
Arm Type
Experimental
Arm Description
health volunteers
Intervention Type
Diagnostic Test
Intervention Name(s)
circulating tumor cell analysis
Intervention Description
Detect circulating tumor cells with CellCollector in SCCHN and control group.
Primary Outcome Measure Information:
Title
CTC isolation
Description
Isolate circulating tumor cells in vivo with CellCollector
Time Frame
9 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
SCCHN confirmed with clinical examination
Have agreed to undergo CTC analysis in vivo;
ECOG：0-2
Exclusion Criteria:
the other cancer types
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenkun Yu, PhD
Phone
+8625 66987199
Email
yuzk@njtrh.org
First Name & Middle Initial & Last Name or Official Title & Degree
Haidong Zhang, PhD
Phone
+86 1879598127
Email
zhanghdent@163.com
Facility Information:
Facility Name
Nanjing Tongren Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
211102
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ZK Yu, PhD
Phone
+8625 66987199
Email
yuzk@njtrh.org
First Name & Middle Initial & Last Name & Degree
HD Zhang, PhD
Email
zhanghdent@163.com
12. IPD Sharing Statement
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CTC Detection Rate in SCCHN With a in Vivo Device
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