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NCT02572778 Clinical Trial

Patient-derived Xenograft Models of Tumor From Patients With Head and Neck Cancer

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

— UCL-Xenog  

Official title:
Establishment of Primary Patient-derived Xenograft Models of Tumor From Patients With Head and Neck Cancer for Preclinical Evaluation of Targeted Therapies.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02572778
Other study ID # UCL-ONCO2015-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2015
Est. completion date December 2025

Study information
Verified date March 2021
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact Aline Gillain, MedSciences
Phone 00322764
Email aline.gillain@uclouvain.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 2025
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Belgium Cliniques universitaires Saint-Luc Brussels

Sponsors (1)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of the biomarkers of new cancer therapies for head and neck cancer on the patient-derived xenografts with immunohistochemistry (KI67) on FFPE (fixation followed by paraffin embedding) slides Identification of the biomarkers of new cancer therapies for head and neck 10 years
Secondary Characterization of the biomarkers of new cancer therapies for head and neck cancer on the patient-derived xenografts with genetic techniques Characterization of the biomarkers of new cancer therapies for head and neck cancer on the patient-derived xenografts with genetic techniques 10 years
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