- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01644786
The Head and Neck Tumor Biobank
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".
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Frank Hoebers, Dr
- Phone Number: +31(0)88 44 55 666
- Email: frank.hoebers@maastro.nl
Study Contact Backup
- Name: Rody Zuidema
- Phone Number: +31(0)88 44 55 666
- Email: rody.zuidema@maastro.nl
Study Locations
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Maastricht, Netherlands, 6229
- Maastro
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bernd Kremer, MD, PhD, Maastricht University Medical Center
- Principal Investigator: Bernd Lethaus, MD, PhD, Maastricht University Medical Center
- Principal Investigator: Ernst-Jan Speel, MD, PhD, Maastricht University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-4-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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