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Patient-derived Xenograft Models of Tumor From Patients With Head and Neck Cancer (UCL-Xenog)

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ClinicalTrials.gov Identifier: NCT02572778
Recruitment Status : Recruiting
First Posted : October 9, 2015
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:

The investigators want to have a collection of fresh primary or recurrent tumor tissue for establishment of patients-derived xenografts in order to:

generate a biobank of in vivo patient xenografts representing the different subgroups of tumors for head and neck cancer

  • perform genetic and transcriptional profiling of the primary, metastatic tumors and xenograft tumors
  • evaluate the efficacy of new targeted agents, whether or not in combination with standard treatment options
  • evaluate biomarkers of drug sensitivity
  • study primary and secondary (acquired) resistance in these models

Condition or disease Intervention/treatment
Squamous Cell Carcinoma of the Head and Neck Procedure: Local biopsy in the tumor

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Establishment of Primary Patient-derived Xenograft Models of Tumor From Patients With Head and Neck Cancer for Preclinical Evaluation of Targeted Therapies.
Study Start Date : September 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Local biopsy in the tumor
    A tumor biopsy of 0.5 cm2 or more will be collected from every patient during surgery or endoscopy after informed consent and if there is enough material after review by the pathologist.


Primary Outcome Measures :
  1. Identification of the biomarkers of new cancer therapies for head and neck cancer on the patient-derived xenografts with immunohistochemistry (KI67) on FFPE slides [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Caracterization of the biomarkers of new cancer therapies for head and neck cancer on the patient-derived xenografts with genetic techniques [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA
Biopsies of the tumor of the patients with squamous cell carcinoma of the head and neck


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
Sampling Method:   Probability Sample
Study Population

All patients with a primary advanced or recurrent head and neck tumor.

  • Inclusion preoperatively or before biopsy
  • Written informed consent prior to surgery or biopsy
Criteria

Inclusion Criteria:

  • In the first phase, all patients with primary or recurrent/ metastatic disease of head and neck cancer can be included pre-operatively or before a tumor biopsy after obtaining informed consent
  • Data on stage, grade, histology, adjuvant treatment, responses, relapse should be available
  • Follow-up data should be available
  • Patients with recurrent disease are allowed
  • Written informed consent

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): NCT02572778


Contacts
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Contact: Aline Gillain, MedSciences 00322764 ext 5498 aline.gillain@uclouvain.be
Contact: Sandra Schmitz, MD, PhD 00322764 ext 5470 sandra.schmitz@uclouvain.be

Locations
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Belgium
Cliniques universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Jean-Pascal Machiels, MD, PhD       jean-pascal.machiels@uclouvain.be   
Contact: Aline Gillain, MedSciences       aline.gillain@uclouvain.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Jean-Pascal Machiels, MD, PhD Cliniques universitaires Saint-Luc

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02572778     History of Changes
Other Study ID Numbers: UCL-ONCO2015-02
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site