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

NCT02572778 | Recruiting

• 1 other identifier: UCL-ONCO2015-02
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (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

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

  10 years

Secondary Outcomes (1)

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

  10 years

Interventions

Local biopsy in the tumor PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biopsies of the tumor of the patients with squamous cell carcinoma of the head and neck

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Jean-Pascal Machiels, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aline Gillain, MedSciences

CONTACT

00322764; aline.gillain@uclouvain.be

Sandra Schmitz, MD, PhD

CONTACT

00322764; sandra.schmitz@uclouvain.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: October 9, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-12

Locations

BE (1)