NCT03071900

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2017

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

March 1, 2017

Last Update Submit

March 1, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • CTC isolation

    Isolate circulating tumor cells in vivo with CellCollector

    9 month

Study Arms (2)

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

Detect circulating tumor cells with CellCollector in SCCHN and control group.

ControlSCCHN

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • the other cancer types

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Tongren Hospital

Nanjing, Jiangsu, 211102, China

RECRUITING

MeSH Terms

Conditions

Neoplastic Cells, CirculatingSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeHead and Neck NeoplasmsNeoplasms by Site

Central Study Contacts

Zhenkun Yu, PhD

CONTACT

Haidong Zhang, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 7, 2017

Study Start

June 22, 2016

Primary Completion

March 15, 2017

Study Completion

April 20, 2017

Last Updated

March 7, 2017

Record last verified: 2017-03

Locations