Circulating Tumor CellNCT03071900
CTC Detection Rate in SCCHN With a in Vivo Device
A study testing circulating tumor cell analysis in people with Circulating Tumor Cell and Squamous Cell Carcinoma of the Head and Neck, run by Nanjing Tongren Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Circulating Tumor Cell, Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- circulating tumor cell analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2016to 20 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SCCHN confirmed with clinical examination
- Have agreed to undergo CTC analysis in vivo;
- ECOG：0-2
Who cannot join
- the other cancer types
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Tongren Hospital
Nanjing, Jiangsu, 211102
ZK Yu, PhD, +8625 66987199, yuzk@njtrh.org
HD Zhang, PhD, zhanghdent@163.com
About this study
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)
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.
- Being tested
- circulating tumor cell analysis
- Medical subject headings
- Neoplastic Cells, Circulating, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circulating tumor cell analysisDiagnostic test
Detect circulating tumor cells with CellCollector in SCCHN and control group.
| Study group | Role | What they receive |
|---|---|---|
| SCCHN | Experimental | squamous cell carcinoma of the head and neck Receives: Diagnostic Test: circulating tumor cell analysis |
| Control | Experimental | health volunteers Receives: Diagnostic Test: circulating tumor cell analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTC isolation
Isolate circulating tumor cells in vivo with CellCollector
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start22 Jun 2016
- Primary completion15 Mar 2017 (estimated)
- Study completion20 Apr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Tumor CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071900
- Sponsor's protocol ID
- NJTRH_CellColletor01
- Status last verified
- Mar 2017
- First submitted
- 1 Mar 2017
- Last updated
- 7 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03071900
- Acronym / sponsor ID
- NJTRH_CellColletor01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nanjing Tongren HospitalUniversity, hospital or other
- Study start
- 22 Jun 2016 (actual)
- Primary completion
- 15 Mar 2017 (estimated)
- Study completion
- 20 Apr 2017 (estimated)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCCHN | Experimental | Diagnostic Test: circulating tumor cell analysissquamous cell carcinoma of the head and neck |
| Control | Experimental | Diagnostic Test: circulating tumor cell analysishealth volunteers |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- SCCHN confirmed with clinical examination
- Have agreed to undergo CTC analysis in vivo;
- ECOG：0-2
Key exclusion criteria (1 listed)
- the other cancer types
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| circulating tumor cell analysisDetect circulating tumor cells with CellCollector in SCCHN and control group. | Diagnostic test | Control, SCCHN |
Primary outcome
CTC isolation
Time frame: 9 month
Isolate circulating tumor cells in vivo with CellCollector
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing circulating tumor cell analysis in people with Circulating Tumor Cell and Squamous Cell Carcinoma of the Head and Neck, run by Nanjing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenkun Yu, PhD (+8625 66987199, yuzk@njtrh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTC isolation (time frame: 9 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.