Protocol for The International Centre for Recurrent Head and Neck Cancer (IReC) Tissue Biobank and Data Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10,000,000
- 主要终点
- Define the 2 year overall survival rates in all patients with rHNC
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 1
Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data only
Group 2
Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data and optional biobank sampling
Group 3
Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data and optional quality of life data
Group 4
Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data and optional quality of life data and optional biobank sampling
结局指标
主要结局
Define the 2 year overall survival rates in all patients with rHNC
时间窗: 2 years
2-year overall survival from date of diagnosis
次要结局
- Define the 2-year disease-free (DFS), disease-specific (DSS), and local recurrence free survival (LRFS) rates in all patients with rHNC.(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.(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(2 years)