Circulating Tumor Cells as an Early Predictive head-and -Neck Squamous-cell Carcinoma (CIRCUTEC)
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|ClinicalTrials.gov Identifier: NCT02119559|
Recruitment Status : Unknown
Verified September 2012 by University Hospital, Montpellier.
Recruitment status was: Recruiting
First Posted : April 21, 2014
Last Update Posted : December 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Head-and-neck Squamous-cell Carcinoma||Other: Blood analysis by EPISPOT and CellSearch®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||115 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Circulating Tumor Cells as an Early Predictive Marker of Response to a First Line Treatment Based on an Anti-Human Epidermal Growth Factor Receptor (HER), Cetuximab, in Patients With Inoperable Recurrent and/or Metastatic Head-and-neck Squamous-cell Carcinoma.|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||March 2018|
CTC assay, Cetuximab
Detection & characterization of viable CTC in the peripheral blood.
Other: Blood analysis by EPISPOT and CellSearch®
Other Name: A counting of CTC using three technologies: EPISPOT, CellSearch®, flow cytometer sorter/analyzer.
- Predictive value of the CTC on the Progression Free Survival [ Time Frame: Duration study 2 years ]The primary outcome aims to evaluate the predictive value of the early progression of the CTC performed with the EPISPOT assay on the progression free survival in a cohort of patients treated with protocol "Extreme". The progression disease is assessed based on imagery techniques.
- Prognostic value of the CTC at baseline (EPISPOT) and to compare for the first time the results with those obtained with the CellSearch system. [ Time Frame: Duration study 2 years ]
- Prognostic value of the CTC at baseline (EPISPOT) [ Time Frame: Duration study 2 years ]
- Predictive value of the early progression of CTC (EPISPOT) on the overall survival [ Time Frame: Duration study 2 years ]
- Compare for the first time the results with those obtained with the CellSearch® system [ Time Frame: Duration study 2 years ]
- Evaluate the expression of EGFR in CTCs before and after administration of cetuximab (Erbitux) with both technologies and EPISPOT CellSearch ® [ Time Frame: Duration study 2 years ]
- Evaluate the impact of the presence of epithelial-mesenchymal transition (EMT) marker on the prognosis [ Time Frame: Duration study 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119559
|Contact: Catherine Alix Panabieres, PhDemail@example.com|
|Principal Investigator:||RENAUD GARREL, MD||CHU GUI DE CHAULIAC|