Head and Neck CancerCTCVADSNCT02892786
Detection in Peripheral Blood of Circulating Tumor Cells in Patient With Head and Neck Squamous Cell Carcinoma
A study testing Circulating Tumor Cells in people with Head and Neck Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
The dissemination of individual tumor cells is a common phenomenon in solid cancers. Detection of tumor cells in peripheral blood circulating tumor cells (CTC) in nonmetastatic situation is of high prognostic significance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Circulating Tumor Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2010to Apr 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patient with head and neck squamous cell cancer stage III or IV histologically proven
- Patient naive to any prior therapy
- Patient with operate cancer and resectable tumor
- Hemoglobin ≥ 10g / dL
- Performance status ≤ 2
- Ability to provide written informed consent
- Patient's legal capacity to consent to study participation
Who cannot join
- Other previous histology tumors
- Medical conditions or acute or chronic severe psychiatric disorders
- Deprived of liberty or under supervision
Trial locations and contacts
1 site in 1 country.
About this study
The dissemination of individual tumor cells is a common phenomenon in solid cancers. Detection of tumor cells in peripheral blood circulating tumor cells (CTC) in nonmetastatic situation is of high prognostic significance.
The objective of our study was to detect circulating tumor cells in two different method in patient with head and neck squamous cell carcinoma .
- Conditions
- Head and Neck Cancer
- Being tested
- Circulating Tumor Cells
- Keywords
- circulating tumor cell, CellSearch™ method, RT-PCR
- Medical subject headings
- Head and Neck Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating Tumor CellsOther
Patients with stage III and IV head and neck squamous cell carcinoma undergoing surgery were enrolled in this study
5 and 7.5 ml of peripheral venous blood will be taken before the surgery, just at the end of surgery and one week after surgery
Analysis was performed by RT-PCR and the CellSearch™ method using immunomagnetic and fluorescence approaches.
Patients will be followed every 3 months for two years.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Not described Receives: Other: Circulating Tumor Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating tumor cells in peripheral blood during head and neck surgery
The number of circulating tumor cells detected per milliliter of peripheral blood will be evaluated on the day before, the day of surgery and 7 days after the surgery.
Measured: 7 days
Secondary outcomes (2)
Comparison between RT-PCR and CellSearch™ method
The comparison between RT-PCR and CellSearch™ method will be the positivity sample rate
Measured: 1 day
Prognostic marker of relapse
Local recurrence, regional or metastatic head and neck cancer in the two years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start8 Dec 2010
- Primary completionDec 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MASTRONICOLA Romina, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892786
- Sponsor's protocol ID
- 2010-A00586-33
- Acronym
- CTCVADS
- Status last verified
- Aug 2026
- First submitted
- 2 Sep 2016
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection in Peripheral Blood of Circulating Tumor Cells in Patient With Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02892786
- Acronym / sponsor ID
- CTCVADS / 2010-A00586-33
- Conditions
- Head and Neck Cancer
- Keywords
- circulating tumor cell, CellSearch™ method, RT-PCR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 8 Dec 2010 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 8 Sep 2016 (estimated)
- 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.
The dissemination of individual tumor cells is a common phenomenon in solid cancers. Detection of tumor cells in peripheral blood circulating tumor cells (CTC) in nonmetastatic situation is of high prognostic significance.
The objective of our study was to detect circulating tumor cells in two different method in patient with head and neck squamous cell carcinoma .
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: Circulating Tumor Cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Patient with head and neck squamous cell cancer stage III or IV histologically proven
- Patient naive to any prior therapy
- Patient with operate cancer and resectable tumor
- Hemoglobin ≥ 10g / dL
Key exclusion criteria (3 listed)
- Other previous histology tumors
- Medical conditions or acute or chronic severe psychiatric disorders
- Deprived of liberty or under supervision
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 CellsPatients with stage III and IV head and neck squamous cell carcinoma undergoing surgery were enrolled in this study 5 and 7.5 ml of peripheral venous blood will be taken before the surgery, just at the end of surgery and one week after surgery Analysis was performed by RT-PCR and the CellSearch™ method using immunomagnetic and fluorescence approaches. Patients will be followed every 3 months for two years. | Other | experimental |
Primary outcome
Circulating tumor cells in peripheral blood during head and neck surgery
Time frame: 7 days
The number of circulating tumor cells detected per milliliter of peripheral blood will be evaluated on the day before, the day of surgery and 7 days after the surgery.
2 secondary outcomes
Comparison between RT-PCR and CellSearch™ method
Time frame: 1 day
Prognostic marker of relapse
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
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RecruitingPhase 2
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RecruitingPhase 4
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Head and Neck Cancer (H&N)
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.
MASTRONICOLA Romina, MD principal investigator
Institut de Cancérologie de Lorraine
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 Cells in people with Head and Neck Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
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 8 inclusion and 3 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: finished, as of the sponsor's last update on 1 Sep 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating tumor cells in peripheral blood during head and neck surgery (time frame: 7 days). 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 1 Sep 2026.