Detection of Circulating Tumor DNA in p16- Locally Advanced Head Neck Squamous Cell Carcinoma (PERSO-NECK)
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|ClinicalTrials.gov Identifier: NCT03896412|
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Locally advanced head and neck squamous cell carcinoma (LAHNSCC) is a heterogeneous disease, associated with a poor prognosis and no improvement in overall survival for years. Furthermore, treatments (surgery, radiotherapy, chemotherapy) are frequently associated with acute and late toxicities. Beside p16/HPV + tumors, only TNM classification can help estimating the prognosis of the patients. A better evaluation of the prognosis and of the risk of metastatic spread would help defining the best treatment.
Circulating tumor DNA (ctDNA) has been reported as both a prognostic factor and a non-invasive way to assess tumor relapse in several cancer types. Few data are available in HNSCC, and no data among p16/HPV- cancers. Indeed, ctDNA assessment is usually based on tumor mutation monitoring. But if recurrent mutations are frequent in several cancers types (PIK3CA, KRAS, ESR1, TERT…), there is no recurrent mutation observed in HNSCC. Thus ctDNA assessment in LAHNSCC must be performed after the identification of a tumor specific mutation for each patient.
In that context, the aim of this study is to perform a molecular analysis of primary LAHNSCC, and to look for the amount of ctDNA before surgery, after surgery, and during 18 months of follow up.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Squamous Cell Carcinoma||Other: Detecton of circulating tumor DNA||Not Applicable|
The patients will be enrolled before surgery and follow-up during 18 months. During patient participation, 20 ml of blood will be collected 7 times (before and after surgery, 6 months after diagnosis and every 3 months thereafter until 18 months of follow up).
Mutation analysis on tumor and healthy tissue will be performed on primary tumors and lymph node dissection, after removal by the surgeon.
Circulating tumor DNA will be detected on blood sample
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Detection of Circulating Tumor DNA by a Personalized Molecular Tool During Treatment of Locally Advanced Operable Head and Neck Squamous Cell Carcinoma|
|Actual Study Start Date :||January 21, 2019|
|Estimated Primary Completion Date :||May 19, 2021|
|Estimated Study Completion Date :||May 19, 2021|
Experimental: Detection of circulating tumor DNA
sampling of 20 ml of blood the day before surgery, the day after , 6 months after diagnosis and every 3 months thereafter until 18 months of follow up
Other: Detecton of circulating tumor DNA
7 blood samples to design a molecular probe
- Percentage of patients with a detectable mutation in ctDNA [ Time Frame: 18 months ]number of patient with detectable mutation with personalized molecular probe
- Kinetics of ctDNA [ Time Frame: 18 months ]Evaluation of the number of patients with an increase or decrease of circulating tumor DNA level
- Kinetics of ctDNA in case of relapse [ Time Frame: 18 months ]Evaluation of the number of patients with an increase or decrease of circulating tumor DNA level
- progression free survival [ Time Frame: 18 months ]time between inclusion and progression and correlation with circulating tumor DNA level
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896412
|Contact: Florian Clatot, MD,PhDfirstname.lastname@example.org|
|Contact: Doriane Richard, PhDemail@example.com|
|Centre Henri Becquerel||Recruiting|
|Rouen, France, 76000|
|Contact: Florian Clatot, Md,PhD +33232082231 firstname.lastname@example.org|
|Contact: Doriane Richard, PhD +33232082985 email@example.com|
|Rouen, France, 76000|
|Contact: Nicolas Bon Mardion, Md,PhD firstname.lastname@example.org|
|Principal Investigator:||Flrorian Clatot, MD,PhD||Centre Henri Becquerel|