Cancer-related PainNCT04007861
Exploring the Link Between Cancer Genetics and PPSP
An observational study of Cancer-related Pain and Chronic Post Cancer Surgery Pain, run by Institute of Cancer Research, United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-related Pain, Chronic Post Cancer Surgery Pain, Breast Cancer
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Although two groups of patients will be identified retrospectively: 1. The first group will be patients who have been referred to the pain management team for persistent-post surgical pain following breast cancer treatment. 2. The second group, will consist of patients who have been matched for age, procedure and time-lapsed since operation. These patients will not have persistent post-surgical pain. Ultimately, archived paraffin-embedded tissue samples, that have previously been taken from these patients, will be requested. Samples accessed will be from patients who have previously provided consent for their samples to be used for research purposes.
Who may be able to join
- 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.
Who cannot join
- Under 18 years of age.
- Lack of adequate tissue sample available from the Tissue Bank.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Exploring the Link Between Cancer Genetics and Persistent Post-surgical Pain (PPSP) Following Breast Cancer Treatment
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.
Read more
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.
Read the detailed description
This study will be a retrospective, case-control study. There will be two groups of patients identified retrospectively:
The first group will be patients who have been referred to the pain management team for persistent-post surgical pain following breast cancer treatment.
The second group, will consist of patients who have been matched for age, procedure and time-lapsed since operation. These patients will not have persistent post-surgical pain.
Archived paraffin-embedded tissue samples, that have previously been taken from these patients, will be required. Samples accessed will be from patients who have previously provided consent for their samples to be used for research purposes. Once appropriate samples have been identified by the tissue banks, all data will be pseudonymised. This will include details that patients have consented to providing for research purposes via the Pain Management Database, which has Trust (CCR 442) and Research Ethics Committee (REC 16/LO/1989) approval.
Laboratory studies will then be conducted to A) investigate the underlying variations of the PIK3CA gene of tumours within the two cohorts of patients, B) investigate other genetic variations between these two groups and C) establish the key genetic and signalling pathway alterations between these two groups.
The methods by which these investigations will be conducted will be by performing PIK3CA genomics, genetic profiling, next generation sequencing and finally immunohistochemistry for activation of signalling pathways.
This study will analyse archived paraffin embedded tissue samples in a laboratory only.
The anticipated time-scale for this project would be approximately one year.
- Medical subject headings
- Cancer Pain, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pain | This will be the group of patients in whom pain is a significant enough problem, that they have been referred to the specialist Pain Management Team. These patients will be identified retrospectively. Patients seen in Pain Management Clinics between 1st of January 2016 and 31st of December 2018, who have consented to be included in the Pain Management database and have a clinician specified pain diagnosis of pain persistent post-surgical pain following breast cancer treatment will be identified. If these patients have an unclear pain diagnosis, they will not be included. | |
| Patients without pain | This will be the group of patients in whom pain is deemed not to be a significant problem. Once again, these patients will be identified retrospectively. Appropriately matched patients to the 52 patients in the "patients with pain" will be identified using records of hospital operating lists by the peri-operative medicine team. Patients will be matched based upon the following details: * Age (within 5 years of matched case) * Surgical procedure (matched for the following elements: * Surgery to breast tissue (biopsy, lumpectomy, wide-local excision or mastectomy) * +/- Sentinal lymph node biopsy or axillary dissection * +/- Reconstruction * Surgical procedure within 3-months of matched case. Provided these individuals have not had an appointment with or referral to the Pain Management Team, they will be included in the matched controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 6-8months
Secondary outcomes (5)
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).
Measured: Within 6-8months
Difference in mean gene expression in those with pain compared with those without pain.
Exploring the difference in gene expression between the two groups.
Measured: Within 6-8months
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).
Measured: Within 6-8months
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).
Measured: Within 6-8months
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.
Measured: Within 6-8months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study startJul 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matt Brown, MBBS, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007861
- Sponsor's protocol ID
- CCR 5006
- Status last verified
- Jul 2019
- First submitted
- 21 Jun 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Link Between Cancer Genetics and Persistent Post-surgical Pain (PPSP) Following Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT04007861
- Acronym / sponsor ID
- CCR 5006
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a retrospective, case-control study. There will be two groups of patients identified retrospectively:
The first group will be patients who have been referred to the pain management team for persistent-post surgical pain following breast cancer treatment.
The second group, will consist of patients who have been matched for age, procedure and time-lapsed since operation. These patients will not have persistent post-surgical pain.
Archived paraffin-embedded tissue samples, that have previously been taken from these patients, will be required. Samples accessed will be from patients who have previously provided consent for their samples to be used for research purposes. Once appropriate samples have been identified by the tissue banks, all data will be pseudonymised. This will include details that patients have consented to providing for research purposes via the Pain Management Database, which has Trust (CCR 442) and Research Ethics Committee (REC 16/LO/1989) approval.
Laboratory studies will then be conducted to A) investigate the underlying variations of the PIK3CA gene of tumours within the two cohorts of patients, B) investigate other genetic variations between these two groups and C) establish the key genetic and signalling pathway alterations between these two groups.
The methods by which these investigations will be conducted will be by performing PIK3CA genomics, genetic profiling, next generation sequencing and finally immunohistochemistry for activation of signalling pathways.
This study will analyse archived paraffin embedded tissue samples in a laboratory only.
The anticipated time-scale for this project would be approximately one year.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pain | – | –This will be the group of patients in whom pain is a significant enough problem, that they have been referred to the specialist Pain Management Team. These patients will be identified retrospectively. Patients seen in Pain Management Clinics between 1st of January 2016 and 31st of December 2018, who have consented to be included in the Pain Management database and have a clinician specified pain diagnosis of pain persistent post-surgical pain following breast cancer treatment will be identified. If these patients have an unclear pain diagnosis, they will not be included. |
| Patients without pain | – | –This will be the group of patients in whom pain is deemed not to be a significant problem. Once again, these patients will be identified retrospectively. Appropriately matched patients to the 52 patients in the "patients with pain" will be identified using records of hospital operating lists by the peri-operative medicine team. Patients will be matched based upon the following details: * Age (within 5 years of matched case) * Surgical procedure (matched for the following elements: * Surgery to breast tissue (biopsy, lumpectomy, wide-local excision or mastectomy) * +/- Sentinal lymph node biopsy or axillary dissection * +/- Reconstruction * Surgical procedure within 3-months of matched case. Provided these individuals have not had an appointment with or referral to the Pain Management Team, they will be included in the matched controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Although two groups of patients will be identified retrospectively: 1. The first group will be patients who have been referred to the pain management team for persistent-post surgical pain following breast cancer treatment. 2. The second group, will consist of patients who have been matched for age, procedure and time-lapsed since operation. These patients will not have persistent post-surgical pain. Ultimately, archived paraffin-embedded tissue samples, that have previously been taken from these patients, will be requested. Samples accessed will be from patients who have previously provided consent for their samples to be used for research purposes.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Under 18 years of age.
- Lack of adequate tissue sample available from the Tissue Bank.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The difference in the proportion of mutations of the PIK3CA gene.
Time frame: Within 6-8months
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.
5 secondary outcomes
Proportion of individual gene mutations in pain group compared with the no pain group.
Time frame: Within 6-8months
Difference in mean gene expression in those with pain compared with those without pain.
Time frame: Within 6-8months
Proportion of individual DNA copy number changes (either amplification/gain or loss) in those with pain compared with those without pain.
Time frame: Within 6-8months
Frequency of changes to DNA copy number (either amplification/gain or loss) in those with pain compared with those without pain.
Time frame: Within 6-8months
Difference in median of magnitude of activation status of signalling pathways between those with pain and those without pain.
Time frame: Within 6-8months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matt Brown, MBBS principal investigator
Royal Marsden NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer-related Pain and Chronic Post Cancer Surgery Pain, run by Institute of Cancer Research, United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Magee, BMBS (020 7808 2771, davidmagee@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the proportion of mutations of the PIK3CA gene. (time frame: Within 6-8months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.