Head and Neck Squamous Cell CarcinomaNCT01644786
The Head and Neck Tumor Biobank
An observational study of Head and Neck Squamous Cell Carcinoma, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- How many people
- 419 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2012to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All new patients with (suspected) mucosal HNSCC who are scheduled for diagnostic panendoscopy
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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".
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.
Read the 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.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- head and neck, HNSCC, orophaynx, hypopharynx, larynx, nasopharynx, oral cavity, prospective study, predictive models for HNSCC, genomic analyses, outcome prediction
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Laryngeal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Main Study Outcome
Locoregional control and/or survival
Measured: from enrollment to follow-up at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2023
- Study completionAug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernd Kremer, MD, PhD, Principal investigator, Maastricht University Medical CenterBernd Lethaus, MD, PhD, Principal investigator, Maastricht University Medical CenterErnst-Jan Speel, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644786
- Sponsor's protocol ID
- 12-4-004
- Status last verified
- Sep 2025
- First submitted
- 17 Jul 2012
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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".
- ClinicalTrials.gov ID
- NCT01644786
- Acronym / sponsor ID
- 12-4-004
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- head and neck, HNSCC, orophaynx, hypopharynx, larynx, nasopharynx, oral cavity, prospective study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Aug 2023 (actual)
- Study completion
- Aug 2025 (actual)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All new patients with (suspected) mucosal HNSCC who are scheduled for diagnostic panendoscopy
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Main Study Outcome
Time frame: from enrollment to follow-up at 5 years
Locoregional control and/or survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernd Kremer, MD, PhD principal investigator
Maastricht University Medical Center
Bernd Lethaus, MD, PhD principal investigator
Maastricht University Medical Center
Ernst-Jan Speel, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Squamous Cell Carcinoma, run by Maastricht Radiation Oncology at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main Study Outcome (time frame: from enrollment to follow-up at 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.