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

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02572778
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 123
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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	Phase
Squamous Cell Carcinoma of the Head and Neck	Procedure: Local biopsy in the tumor

Study Design

• Study Type: Observational
• Anticipated 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: Sep 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2025

Outcome Measures

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 (fixation followed by paraffin embedding) slides [10 years]

   Identification of the biomarkers of new cancer therapies for head and neck

Secondary Outcome Measures

1. Characterization of the biomarkers of new cancer therapies for head and neck cancer on the patient-derived xenografts with genetic techniques [10 years]

   Characterization of the biomarkers of new cancer therapies for head and neck cancer on the patient-derived xenografts with genetic techniques

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cliniques universitaires Saint-Luc	Brussels		Belgium	1200

Sponsors and Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

• Principal Investigator: Jean-Pascal Machiels, MD, PhD, Cliniques universitaires Saint-Luc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• ClinicalTrials.gov Identifier: NCT02572778
• Other Study ID Numbers: UCL-ONCO2015-02
• First Posted: Oct 9, 2015
• Last Update Posted: Mar 19, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Mar 19, 2021