The Head and Neck Tumor Biobank

Sponsor

Maastricht Radiation Oncology (Other)

Overall Status

Recruiting

CT.gov ID

NCT01644786

Collaborator

(none)

800

Enrollment

Location

156

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the biobank is to enable future genomic based research on this Head and Neck Cancer patient population. The investigators will try to identify tumor factors that will predict cancer-related outcome in order to improve the outcome prediction after treatment in a patient-individualized manner.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Squamous Cell Carcinoma

Detailed Description

This is a prospective, non-interventional longitudinal study in patients with HNSCC. Patients will have their normal routine workup including the standard panendoscopy, during which usually multiple biopsies for diagnostic histo-pathology are obtained. Part of one of these biopsies will be stored in the HN Tumor Biobank. There will be no change in the subsequent proposed treatment, which may consist of primary surgery (with or without postoperative (chemo-) radiation) or definitive (chemo-) radiation.

The primary and general objective of this project is to develop, validate, and improve predictive models for different endpoints that are relevant for patients after curatively intended treatment of HNSCC. These endpoints include loco-regional tumour control and overall survival.

Primary Objective: To build a biobank of tumor tissue from all HNSCC patients for future genomic analyses.

Secondary Objective: To improve the outcome prediction, based on both clinical factors and tumour gene expression profiles.

Hypothesis:

Our general hypothesis is that a more accurate estimation of locoregional control and overall survival can be achieved when prognostic factors are taken into account different from than the currently used 'classical' prognostic factors, such as TNM-stage.

The investigators hypothesize that the final outcome of this project will allow us to improve the performance of predictive models for HNSCC. The performance of our prediction models will be quantified by AUC for binary outcome measures and with the c-statistic for survival analysis. The ultimate objective will be to achieve an AUC of at least 0.90. Such a performance will allow us to build a Decision Support System based on these predictive models that provides information to physicians with regard to the probability of loco-regional failure and overall survival in individual patients.

Study parameters/endpoints:

Because no specific gene-signature has yet been defined that is applicable to a large population of HNSCC patients, no specific endpoint can be named.

However, the main study endpoint will be the accuracy of a certain gene-signature that may contribute or rather improve the outcome prediction of patients. Outcome is defined as locoregional control and/or survival. The outcome of the patients is currently recorded in the electronic medical charts of azM and of Maastro Clinic and at the time of analysis, these clinical outcome data will be coupled blinded to the data generated from the tumor-biopsy analysis The goal is to achieve an AUC of at least 0.90. Such a performance will allow us to build a Decision Support System.

Study Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Storage of Head and Neck Tumor Samples in a Biobank for Future Genomic-based Research Aiming at Improved Outcome Prediction: " The Head and Neck Tumor Biobank".

Actual Study Start Date :

Aug 1, 2012

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2025

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient with (suspected) mucosal HNSCC
Tumor site: oropharynx, hypopharynx, larynx, nasopharynx, or oral cavity
Scheduled for panendoscopy under general anesthesia
Tumor size that permits harvesting of multiple biopsies, without risk of functional damage
No previous treatment, except previous biopsy
Age >= 18 years

Exclusion Criteria:

Small primary tumors, e.g. vocal cord tumors, that are too small to obtain multiple biopsies because of the associated risk of functionale damage
Patients not undergoing panendoscopy during routine clinical work-up, e.g. because of examination under general anaesthesia already performed elsewhere, before referral to azM.