NCT01644786

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
419

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

11 years

First QC Date

July 17, 2012

Last Update Submit

September 30, 2025

Conditions

Keywords

head and neckHNSCCorophaynxhypopharynxlarynxnasopharynxoral cavityprospective studypredictive models for HNSCCgenomic analysesoutcome prediction

Outcome Measures

Primary Outcomes (1)

  • Main Study Outcome

    Locoregional control and/or survival

    from enrollment to follow-up at 5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All new patients with (suspected) mucosal HNSCC who are scheduled for diagnostic panendoscopy

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastro

Maastricht, 6229, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

mucosal HNSCC oropharynx, hypopharynx, larynx, nasopharynx, oral cavity

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckLaryngeal Diseases

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 19, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2023

Study Completion

August 1, 2025

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations