IReC-Bio and IReC Registry

Official title

Protocol for The International Centre for Recurrent Head and Neck Cancer (IReC) Tissue Biobank and Data Registry

Overview

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.

Detailed description

There are currently only a limited number of proven treatments for use in cancers of the head and neck, and a better understanding of the biology of different HNCs could lead to improved therapies. Although many patients with head and neck cancer can be offered potentially curative treatment, we do not understand why some people are cured and others are not. There has been an explosion in molecular research in many cancers, but this remains an understudied area in head and neck cancer. There are currently no treatments available to patients with head and neck cancer based on molecular characteristics.

The purpose of IReC-BIO is to support research into rHNCs. 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.

Cancer registries store large quantities of data from defined cancer populations. Registry aims vary, but include analysing cancer trends over time and supplying data for research studies5-7. The NCDB and SEER are extensively studied registries, producing \>200 publications per year6. Both provide a broad overview of all major cancers; however, they have notable datapoint gaps, in particular, recurrence and patient reported outcome measures (PROMs).

Establishing a cancer registry necessitates a balance of clinical, informatic, and financial influences. Cancer registry development is subject to numerous pitfalls, ranging from excessive datapoints to inadequate quality assurance7. These can be mitigated through adherence to best practice recommendations, for example the NAACCR and ENCR, which provide guidelines that standardise registry datasets8,9. However, not all recommendations are practical across all cancer diagnoses. In particular, rHNC requires a tailored approach to document the treatment and functional implications unique to this cohort, necessitating development of a registry specific to this disease.

Primary outcome measures

• Define the 2 year overall survival rates in all patients with rHNC [Time frame: 2 years]

Secondary outcome measures (3)

• Define the 2-year disease-free (DFS), disease-specific (DSS), and local recurrence free survival (LRFS) rates in all patients with rHNC. [Time frame: 2 years]
• 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 [Time frame: 2 years]
• Assess swallow with Performance Status Scale for head and neck cancer patients (PSS-HN) scores up to 2 years after diagnosis of rHNC. [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

• 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.
• Details of clinical follow-up available

For IReC-BIO only:

• FFPE blocks(s) or fresh frozen tumour tissue available for collection
• Two or more tumour-containing blocks available from the same specimen

For QoL Questionnaires only:

• Patients who have received a diagnosis of rHNC no earlier than 6 weeks prior to study entry

Exclusion criteria

• Recurrent cutaneous (e.g., SCC, melanoma), sarcomatous, and lymphatic or haematological (e.g. lymphoma) malignancies of the head and neck

For IReC-BIO only:

• FFPE tumour samples contain insufficient tumour sample for analysis.
• Insufficient clinical details available

For QoL Questionnaires only:

• Patients who have received a diagnosis of rHNC more than 6 weeks prior to study entry

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05885490 · 5604

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗