Breast Cancer Clinical Trial
Official title:
Exploring the Link Between Cancer Genetics and Persistent Post-surgical Pain (PPSP) Following Breast Cancer Treatment
NCT number | NCT04007861 |
Other study ID # | CCR 5006 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 2019 |
Est. completion date | December 2019 |
Pain is common in cancer, affecting between 40 and 60% of patients depending on tumour type
and stage of disease, and represents a major area of unmet need in cancer survivors. Despite
advances in treatment, there has been no significant reduction in those who experience pain.
Breast cancer is common. It represents 10% of newly diagnosed cancers globally and is often
associated with pain.
Exact physiological mechanisms for cancer pain are not yet fully established. There is a
complex relationship between a malignant lesion and its micro-environment; a tumour does not
exist in isolation but has a dynamic relationship with host cells. There is a growing
interest in delineating the relationship between tumour manifestations and pain.
By retrospectively identifying individuals who have been referred to specialist pain clinics
at a cancer centre and matching them to controls, the investigators can identify two groups
of patients (those who experienced significant problems with pain and those who did not).
Accessing paraffin-embedded tissue samples from those that have had surgical resections, will
allow the investigators to compare tissue samples, in particular the metabolic and genetic
differences, between the two groups.
No new tissue samples will be required for this study.
Pain is a major area of unmet need in cancer survivors. The investigators propose that this
project would provide valuable knowledge and pilot data regarding the link between pain and
tumour genetics. It has the potential to identify tumour genes or mutations that are
associated with greater incidences of pain and ultimately potentially guide targeted
interventions to help reduce the frequency and impact of pain on patients living with and
beyond cancer.
Status | Not yet recruiting |
Enrollment | 104 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients receiving treatment at the Royal Marsden Hospital. - Patients with a diagnosis of primary breast cancer. - Patients who have had surgical resection of their breast tumour. - Paraffin-embedded tissue samples available from Royal Marsden Tissue Banks. Exclusion Criteria: - Under 18 years of age. - Lack of adequate tissue sample available from the Tissue Bank. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Institute of Cancer Research, United Kingdom |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The difference in the proportion of mutations of the PIK3CA gene. | PIK3CA genomics will result in a binary measure (either wild-type or mutant). The difference in proportion of the PIK3CA gene mutation in those with persistent post-surgical pain compared with those without persistent post-surgical pain will be the primary outcome measure. | Within 6-8months | |
Secondary | Proportion of individual gene mutations in pain group compared with the no pain group. | DNA analysis will determine the presence or absence of other gene mutations (binary outcome). | Within 6-8months | |
Secondary | Difference in mean gene expression in those with pain compared with those without pain. | Exploring the difference in gene expression between the two groups. | Within 6-8months | |
Secondary | Proportion of individual DNA copy number changes (either amplification/gain or loss) in those with pain compared with those without pain. | DNA copy number can either be unchanged or changed. Changes are described as either 'amplification/gain' or 'loss'. Data will be analysed as binary data (either no change or change). | Within 6-8months | |
Secondary | Frequency of changes to DNA copy number (either amplification/gain or loss) in those with pain compared with those without pain. | DNA copy number can either be unchanged or changed. Changes are described as either 'amplification/gain' or 'loss'. Data will be analysed as binary data (either no change or change). | Within 6-8months | |
Secondary | Difference in median of magnitude of activation status of signalling pathways between those with pain and those without pain. | Comparison the activation status of signalling pathways between the two groups. The magnitude of activation status will be reported as a percentage. | Within 6-8months |
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