CTC Detection Rate in SCCHN With a in Vivo Device | NCT03071900

Studies
CTC Detection Rate in SCCHN With a in Vivo Device

NCT03071900

Sponsor

Nanjing Tongren Hospital

Status

Unknown status

Last Update Posted

Mar 7, 2017Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Circulating Tumor Cell
Squamous Cell Carcinoma of the Head and Neck

Interventions

circulating tumor cell analysis

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 22, 2016Actual

Primary Completion Date

Mar 15, 2017Estimated

Completion Date

Apr 20, 2017Estimated

First Submitted Date

Mar 1, 2017

First Submission Date that Met QC Criteria

Mar 1, 2017

First Posted Date

Mar 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2017

Last Update Posted Date

Mar 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SCCHN	Experimental	squamous cell carcinoma of the head and neck	Diagnostic Test: circulating tumor cell analysis
Control	Experimental	health volunteers	Diagnostic Test: circulating tumor cell analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
circulating tumor cell analysis	Diagnostic Test	Detect circulating tumor cells with CellCollector in SCCHN and control group.	Control SCCHN

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhenkun Yu, PhD	Contact	+8625 66987199		yuzk@njtrh.org
Haidong Zhang, PhD	Contact	+86 1879598127		zhanghdent@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing Tongren Hospital	Recruiting	Nanjing	Jiangsu	211102	China

Condition Browse Module

MeSH Terms

ID	Term
D009360	Neoplastic Cells, Circulating
D000077195	Squamous Cell Carcinoma of Head and Neck

Ancestor Terms

ID	Term
D009362	Neoplasm Metastasis
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes

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Browse Branches

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