Rapid Diagnostic Centre Biomarker Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 10
- 主要终点
- Accuracy of Clinical Data Analysis
研究概览
简要总结
Rapid Diagnostic Centres
Rapid Diagnostic Centres (RDC) were built to diagnose patients who have common symptoms that occur in cancer, but it is unclear if they have cancer or not. These symptoms include:
- Weight loss
- Fatigue
- Cough
- GP suspicion
Only 1 in every 10 patients (10%) referred to an RDC will have cancer. Some of the patients with cancer may have been more likely to develop cancer due to inherited or environmental factors. Some of the patients who don't have cancer may also be at higher risk of developing cancer at another time due to inherited or environmental factors.
Aims
The goal of this observational study is to develop a new blood or non-blood test that could help doctors at RDC:
- detect which patients have cancer through a simple and quick blood or non-blood test
- detect patients who are at higher risk of having cancer. This is so they can be monitored or guided towards cancer-screening programmes
Main End Points
- The study will be considered a success if a test or mixture of tests is developed that can correctly sort patients into cancer or non-cancer groups.
- Also, the study will be considered a success if a test or mixture of tests can show what type of cancer a patient has if they have cancer.
Tests
To create this new blood or non-blood test the study will take the following samples from 1000 patients in the RDC Biomarker Study:
- Breath samples (around 300 patients) - People with cancer have different levels of chemicals in their breath than people without cancer. The study hopes to develop a breath test which could show if a patient has cancer or not.
- Blood samples ( around 1000 patients) - The study hopes to develop a blood test that could show if a patient has cancer or not
- Saliva samples (around 1000 patients) - For many cancers, while there is a genetic component there is no one single gene that causes cancer. Instead, it can be a combination of hundreds of genes that causes the risk of cancer in a person to go up. The study hopes to develop a test which could provide a risk score. This risk score is called a 'polygenic risk score' which would tell doctors how likely a patient is to get cancer.
Method Patients who meet the criteria to be able to join the study will be asked either via telephone before their appointment, or face-to-face at an appointment at the RDC if they would like to join the study. If they agree to join the study they will read a patient information sheet and sign a consent form to say they understand what the study requires.
The patient will then provide blood and saliva samples and in some cases breath samples at their first appointment. They will be then asked to provide further samples (up to three) at their follow-up appointments. Please see below for samples that will be asked for at each appointment:
First appointment: Breath (not all sites), Blood, Saliva (not all sites), Survey Follow-up 1: Any samples that could not be taken at the first appointment Follow-up 2: Any samples that could not be taken at the first appointment
The patient will be provided with a Study ID to identify their samples. This is a unique code to identify each person on the study. Only the site that recruited the participant will have access to the personal information that matches which patients is known by which Study ID. All organisations external to the site will only know the patient as the Study ID. An example of the study ID could be RDCRMH001.
A trained clinical member of the research team at the RDC will take the sample and ship it to the relevant laboratory for testing.
As well as blood and non-blood tests, information about the patients will be collected This includes routinely collected clinical data alongside investigation results. No patient identifiable information such as:
- Name
- Address
- Date of birth
- Contact details
will be collected, and a Study ID will be used to identify the data.
A patient questionnaire will be sent out to patients to complete for each appointment asking questions about the patient's health. The RDC doctors treating the patient will see survey answers before the appointment to allow them to act about anything worrying.
For a small group of patients anonymised copies of thier scans from their medical records will also be taken.
Study Duration Once the study has recruited 1000 patients, it will close to recruitment. These patients will then be followed up for 12 months following the date they joined the study.
详细描述
Background
The proposed research will focus on Rapid Diagnostic Centres (RDCs) already established across multiple sites in England. Since 2019-2020, RDCs, have begun rolling out nationally across all cancer alliances. They are a single point of access for cancer diagnostics to allow personalised and rapid diagnosis of patients presenting with non-specific but concerning symptoms of cancer (NSCS).
Cancer patients with NSCS typically have a longer interval in primary care to referral and have more advanced disease once a diagnosis is made, yet approximately 50% of cancer patients present with NSCS. These patients are poorly served by existing cancer referral pathways which can be circuitous when a clear pattern of symptoms is not present.
The objectives of RDCs are to:
- Support earlier and faster cancer diagnosis
- Create increased capacity through more efficient diagnostic pathways
- Deliver a better, personalised diagnostic experience for patients
- Reduce unwarranted variation in referral for, access to and in the reliability of relevant diagnostic tests
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred to undergo investigation for suspected cancer within a non-tumour site specific RDC
- •Age > 18 years
排除标准
- •Previously treated (treatment completed within 5 years preceding recruitment)
- •Current confirmed diagnosis of active malignancy
- •Unable to or unwilling to give informed consent
结局指标
主要结局
Accuracy of Clinical Data Analysis
时间窗: 5 years
The main analysis, including clinical data values, will be descriptive and will be focused to inform future prospective studies. For continuous variables, the mean and standard deviation will be presented, together with the mean between-group difference, and 95% confidence interval. For binary outcomes, the percentage and frequency of patients in the outcome category of interest will be presented. When necessary intracluster correlation coefficients will be reported, together with 95% confidence interval. Where appropriate p-values will be presented.
Number of patients with accurate Imaging Radiomics and Composite Analysis
时间窗: 5 years
Inclusion of radiomics data will be assessed for subsets of patients where robust imaging data and appropriate techniques for analysis exist, noting the predominance evidence available for certain tumour types such as lung cancer.
Number of Participants with Multiparametric and ML Analyse outcome measures
时间窗: 5 years
The study will explore the role of multi-parametric predictors by optimising convolutional neural networks (CNN) or other deep learning tool to classify patients into outcome classes.
Accuracy of Polygenic Risk Scores
时间窗: 5 years
For most laboratory data analysis, the known relevance of a positive detection through a clinical biomarker shall not be known prior to the completion of data analysis, however for PRS analysis this would theoretically be able to provide information on 10-year and lifetime cancer risk for breast, colon, endometrial, melanoma, ovarian, pancreas, and prostate cancers. The level of risk will be determined as a risk-ratio of 2 or ≥3 compared to the general population for moderate- and high-risk individuals respectively.
次要结局
未报告次要终点