The Relationship of Intra-epidermal Nerve Fibre Density (IENFD) and Structure to Chronic Post-Mastectomy Pain Syndrome (PMPS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Relationship of intra-epidermal nerve fibre density to the presence of post-mastectomy pain syndrome as assessed by validated questionnaires
研究概览
简要总结
This is a retrospective, observational study which will utilise the Edinburgh Cancer Research Centre's Tissue Bank to provide samples for IENFD testing in those who have undergone mastectomy surgery for breast cancer.
The investigators shall identify all those patients in the Tissue Bank database who have undergone mastectomy surgery for breast cancer. The investigators shall consult the patient's electronic health record, and general practitioner if required, to ascertain whether the patient has died, been diagnosed with cognitive impairment or a psychotic disorder, or receiving ongoing oncological treatment which would exclude them from the study. The investigators shall also exclude all those patients who received surgery within the last year as we intend to elucidate the presence of pain in the immediate post-operartive period up to 12 months post-operatively.
Having identified these patients the investigators shall contact them via post with a pack containing an information document, a consent form and questionnaires. As this is an observational study we shall contact all of the identified patients who meet the inclusion criteria with the aim of recruiting as many as possible. The investigators would anticipate a high response rate as has been the experience with previous questionnaire studies of breast cancer patients.
Once a signed consent form has been returned the patient's tissue sample would undergo IENFD testing. Their questionnaire responses will allow participants to be split into two groups based upon whether they experience CPSP or not. Blinding of this grouping will take place so that those undertaking the IENFD testing are unaware of the patient's questionnaire responses.
Statistical analysis of the two group's IEFD results and questionnaire responses will then be undertaken with the null hypothesis that the pre-operative IENFD at the site of surgery does not predict or correlate with CPSP.
详细描述
Study Design This study will use pre-existing skin samples stored in the Edinburgh Experimental Cancer Medicine Centre (ECMC) / SAHSC BioResource (collected from 2006-2012) from patients who have undergone breast cancer surgery.
The investigators shall firstly identify all samples in the Tissue Bank database that were taken from those undergoing breast cancer surgery. Before any patient details are provided the investigators will confirm that the patient has initialled the following section of the consent form they completed at the time of their surgery;
"I agree to my name and details being made available to other ECMC researchers who might approach me to invite participation in other research projects. These might include studies of new treatments or techniques, clinical or genetic studies of the causes of cancer or cancer outcomes. I understand that that this permission does not commit me to participate in such studies and I will be able to decide whether I wish to be involved once I have reviewed any information sheet and consent form."
Once this has been confirmed, the investigators shall consult the patient's electronic health record to ascertain whether anything would exclude them from the study such as death, a new diagnosis of cognitive impairment or a psychotic disorder, or receiving current oncological treatment.
As this is an exploratory study the investigators shall contact all of the identified patients who meet the inclusion criteria with the aim of recruiting as many as possible. The investigators would anticipate a high response rate, as has been the experience with previous questionnaire studies involving breast cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient has Tissue Bank sample stored in the Edinburgh Experimental Cancer Medicine Centre (ECMC) / SAHSC BioResource.
- •At the time of their surgery, the patient provided written consent for the sample to be used by future researchers and to be contacted by those researchers.
- •Patient has undergone surgery for breast cancer.
- •Contact details for the patient are available.
- •Patient is able to provide informed consent for the questionnaire component of the study.
- •Patient is able to complete and return study questionnaires. Telephone support to help complete the study documentation will be provided if requested.
排除标准
- •Patient who had their surgery outwith the timeframe of the original study consent (2006-2012)
- •Patients receiving active oncological treatment.
- •Patients who have died.
- •Patients with cognitive impairment or significant mental health disorder.
- •Patients with active complications of their surgical wound site.
结局指标
主要结局
Relationship of intra-epidermal nerve fibre density to the presence of post-mastectomy pain syndrome as assessed by validated questionnaires
时间窗: From time of original surgery to current date - could be up to 5 years after surgery
次要结局
未报告次要终点
研究者
Oliver Daly
Consultant Anaesthetist
Royal Infirmary of Edinburgh