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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
Sponsor:
Information provided by (Responsible Party):
Centre Henri Becquerel

Brief Summary:

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

Detailed Description:

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Percentage of patients with a detectable mutation in ctDNA [ Time Frame: 18 months ]
    number of patient with detectable mutation with personalized molecular probe


Secondary Outcome Measures :
  1. Kinetics of ctDNA [ Time Frame: 18 months ]
    Evaluation of the number of patients with an increase or decrease of circulating tumor DNA level

  2. 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

  3. progression free survival [ Time Frame: 18 months ]
    time between inclusion and progression and correlation with circulating tumor DNA level



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Operable Head and neck squamous cell carcinoma (T3-T4 stage and/or N+)
  • No p16 expression
  • Curative treatment proposed based on surgery + radiotherapy (+/- chemotherapy)
  • PS<3
  • Written consent signed

Exclusion Criteria:

  • Metastatic spread
  • Previous radiotherapy of head or neck
  • Previous HNSCC (except carcinoma restricted to glottis, with a surgery treatment alone and >3 years of follow up without relapse)

Information from the National Library of Medicine

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): NCT03896412


Contacts
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Contact: Florian Clatot, MD,PhD +33232082231 floriane.clatot@chb.unicancer.fr
Contact: Doriane Richard, PhD +33232082985 doriane.richard@chb.unicancer.fr

Locations
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France
Centre Henri Becquerel Recruiting
Rouen, France, 76000
Contact: Florian Clatot, Md,PhD    +33232082231    florian.clatot@chb.unicancer.fr   
Contact: Doriane Richard, PhD    +33232082985    doriane.richard@chb.unicancer.fr   
CHU Recruiting
Rouen, France, 76000
Contact: Nicolas Bon Mardion, Md,PhD       nicolas.bon-mardion@chu-rouen.fr   
Sponsors and Collaborators
Centre Henri Becquerel
Investigators
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Principal Investigator: Flrorian Clatot, MD,PhD Centre Henri Becquerel

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Responsible Party: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT03896412     History of Changes
Other Study ID Numbers: CHB18.03
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Henri Becquerel:
circulating tumor DNA
Next Generation Sequencing
Digital PCR
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site