CTC Detection Rate in SCCHN With a in Vivo Device

March 1, 2017 updated by: Nanjing Tongren Hospital

Enumeration and Molecular Characterization of Circulating Tumor Cells (CTCs) Using a in Vivo Device in Squamous Cell Carcinoma of Head and Neck (SCCHN)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 211102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • SCCHN confirmed with clinical examination
  • Have agreed to undergo CTC analysis in vivo;
  • ECOG：0-2

Exclusion Criteria:

  • the other cancer types

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CTC isolation
Time Frame: 9 month
Isolate circulating tumor cells in vivo with CellCollector
9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2016

Primary Completion (Anticipated)

March 15, 2017

Study Completion (Anticipated)

April 20, 2017

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

March 1, 2017

First Posted (Actual)

March 7, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJTRH_CellColletor01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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