Examples
Translational research in action
Cardiovascular
trials
Oncology
trials
Personalised
medicine
Translational research
in cardiovascular trials
In the FIELD trial (Fenofibrate Intervention and Event Lowering
in Diabetes), blood samples were collected from
1800 consenting patients. Genome-wide association studies
(GWAS) for prognostic biomarkers are currently under way.
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Translational research
in oncology trials
Patients in about 25% of our oncology trials have had the option
to consent to biospecimen collection for research. Over 85% of
currently recruiting oncology trials have laboratory components,
that is:
- Biomarker pretesting for
eligibility 20% (8
trials)
- Defined laboratory
studies
50% (21 trials)
- Future unspecified future
studies over
15% (>12 trials)
In the past 6 years, publications relating to integrated
translational research have increased from 0% to about 50%.
Molecular testing for eligibility for a clinical
trial
Sometimes a trial focuses on a specific subgroup of
patients. For example, in CATNON (EORTC 26053_22054, COGNO
collaborative trials group), only anaplastic glioma patients
without the 1p/19q chromosomal deletion are eligible. This subgroup
is known to have a median survival of 2 to 3 years; patients with
the 1p/19q co-deletion have a much longer median survival, over 6
to 7 years.
Defined translational research studies
In the EVERSUN trial (ANZUP collaborative
trials group), renal cell carcinoma patients receive an alternating
regimen of mTOR inhibitor (everolimus) and a receptor tyrosine
kinase inhibitor (sunitinib). The laboratory component of the
study will examine circulating tumour cells and a range
of serum biomarkers, including those involved in the angiogenesis
pathway, as potential prognostic biomarkers or predictors of
response.
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Personalised medicine
One of our aims is to develop evidence
for personalised medicine, where the treatment is tailored to
the individual.
An example of T1 research that changed clinical
practice is the CO.17 colorectal cancer trial conducted
by the CTC and the AGITG in collaboration with the
National Cancer Institute of Canada Clinical Trials
Group.
The trial commenced in 2003, and the results, published in
the New England Journal of Medicine (Karapetis et al. 2008), showed that
patients whose colorectal tumours had the wild-type
(normal) KRAS gene treated with the epidermal
growth-factor receptor (EGRF) inhibitor, cetuximab, had
significantly better overall survival than patients with
the mutated KRAS gene.
That same year, the National Comprehensive Cancer Network
published clinical practice guidelines regarding KRAS
gene testing for colorectal cancer patients. This
illustrates very rapid uptake of a research finding in
clinical practice.
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