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CTC Detection Rate in SCCHN With a in Vivo Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071900
Recruitment Status : Unknown
Verified March 2017 by Nanjing Tongren Hospital.
Recruitment status was:  Recruiting
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Nanjing Tongren Hospital

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.

Condition or disease Intervention/treatment Phase
Circulating Tumor Cell Squamous Cell Carcinoma of the Head and Neck Diagnostic Test: circulating tumor cell analysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
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)
Actual Study Start Date : June 22, 2016
Estimated Primary Completion Date : March 15, 2017
Estimated Study Completion Date : April 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SCCHN
squamous cell carcinoma of the head and neck
Diagnostic Test: circulating tumor cell analysis
Detect circulating tumor cells with CellCollector in SCCHN and control group.

Experimental: Control
health volunteers
Diagnostic Test: circulating tumor cell analysis
Detect circulating tumor cells with CellCollector in SCCHN and control group.




Primary Outcome Measures :
  1. CTC isolation [ Time Frame: 9 month ]
    Isolate circulating tumor cells in vivo with CellCollector



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071900


Contacts
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Contact: Zhenkun Yu, PhD +8625 66987199 yuzk@njtrh.org
Contact: Haidong Zhang, PhD +86 1879598127 zhanghdent@163.com

Locations
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China, Jiangsu
Nanjing Tongren Hospital Recruiting
Nanjing, Jiangsu, China, 211102
Contact: ZK Yu, PhD    +8625 66987199    yuzk@njtrh.org   
Contact: HD Zhang, PhD       zhanghdent@163.com   
Sponsors and Collaborators
Nanjing Tongren Hospital
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Responsible Party: Nanjing Tongren Hospital
ClinicalTrials.gov Identifier: NCT03071900    
Other Study ID Numbers: NJTRH_CellColletor01
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplastic Cells, Circulating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes