IReC-Bio and IReC Registry
ConditionHead Cancer Neck
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorRoyal Marsden NHS Foundation Trust
About this trial
IReC is the world's first centre for recurrent head and neck cancers. We have the ambitious aim to create a centre of international excellence and set international standards in the curative treatment of recurrent head and neck cancers.
One of IReC's key objectives is to develop a national research tissue bank to support laboratory and translational research. The cornerstone of translational research is a well-annotated biobank of cancer samples to explore and validate key research findings.
The purpose of IReC-Bio is to support research into recurrent head and neck cancers. A central repository for the rarer recurrent cancers will allow the concentration of cases required in order to support translational research programmes. The overall aim is to facilitate research into understanding disease biology, identifying potentially curative treatments, and allow detailed investigations into the relationships between clinical, pathological and molecular characteristics and clinical outcomes.
Combining the IReC Registry and Biobank gives us a comprehensive data and sample set which has never been created before for recurrent head and neck cancer. The aim is to have a national, and in the future international, resource of the study of recurrent head and neck cancer on a molecular and clinical level to support novel ways of treating rHNC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged over 18 at time of diagnosis.
Confirmed clinical, radiological, and/ or histological diagnosis of residual, recurrent, or new primary malignant head and neck cancer arising from the nasopharynx, oropharynx, oral cavity, larynx, hypopharynx, sinonasal cavities, major salivary glands and thyroid gland.
Any mucosal, salivary gland, and thyroid histological subtype
Ability to give informed consent.
Disqualifiers
FFPE tumour samples contain insufficient tumour sample for analysis.
Insufficient clinical details available
Trial population
Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
10,000,000 Participants
are grouped into 4 trial groupsGroup A: Group 1
Group B: Group 2
Group C: Group 3
Group D: Group 4
Trial outcomes
Primary outcomes
1
Define the 2 year overall survival rates in all patients with rHNC
2-year overall survival from date of diagnosis
Time frame
2 yearsSecondary outcomes
1
Define the 2-year disease-free (DFS), disease-specific (DSS), and local recurrence free survival (LRFS) rates in all patients with rHNC.
2 year disease free survival, disease specific and local recurrence free survival rates in all patients with rHNC
Time frame
2 years2
Define long-term functional outcomes after diagnosis of rHNC using gastrostomy and tracheostomy use as a surrogate marker up to 2 years after diagnosis with rHNC
1 and 2-year gastrostomy and tracheostomy status from date of diagnosis
Time frame
2 years3
Assess swallow with Performance Status Scale for head and neck cancer patients (PSS-HN) scores up to 2 years after diagnosis of rHNC.
Entry, 6, 12 and 24-month PSS-HN NOD scores
Time frame
2 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: