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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

Tracking Information
First Submitted Date  ICMJE February 5, 2019
First Posted Date  ICMJE April 1, 2019
Last Update Posted Date April 1, 2019
Actual Study Start Date  ICMJE January 21, 2019
Estimated Primary Completion Date May 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
Percentage of patients with a detectable mutation in ctDNA [ Time Frame: 18 months ]
number of patient with detectable mutation with personalized molecular probe
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Detection of Circulating Tumor DNA in p16- Locally Advanced Head Neck Squamous Cell Carcinoma
Official Title  ICMJE Detection of Circulating Tumor DNA by a Personalized Molecular Tool During Treatment of Locally Advanced Operable Head and Neck Squamous Cell Carcinoma
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.

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Head and Neck Squamous Cell Carcinoma
Intervention  ICMJE Other: Detecton of circulating tumor DNA
7 blood samples to design a molecular probe
Study Arms  ICMJE 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
Intervention: Other: Detecton of circulating tumor DNA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 19, 2021
Estimated Primary Completion Date May 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Florian Clatot, MD,PhD +33232082231 floriane.clatot@chb.unicancer.fr
Contact: Doriane Richard, PhD +33232082985 doriane.richard@chb.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03896412
Other Study ID Numbers  ICMJE CHB18.03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Henri Becquerel
Study Sponsor  ICMJE Centre Henri Becquerel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Flrorian Clatot, MD,PhD Centre Henri Becquerel
PRS Account Centre Henri Becquerel
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP