Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05885490 |
Other study ID # |
5604 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 2024 |
Est. completion date |
December 2050 |
Study information
Verified date |
May 2024 |
Source |
Royal Marsden NHS Foundation Trust |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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.
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.