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

March 18, 2021 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 10 years
Identification of the biomarkers of new cancer therapies for head and neck
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of the biomarkers of new cancer therapies for head and neck cancer on the patient-derived xenografts with genetic techniques
Time Frame: 10 years
Characterization of the biomarkers of new cancer therapies for head and neck cancer on the patient-derived xenografts with genetic techniques
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (Estimate)

October 9, 2015

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCL-ONCO2015-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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