A Randomised Trial to Evaluate the cfDNA Pancreatic Cancer Test (Avantect) in the Early Detection of Pancreatic Cancer in Patients With Newly Diagnosed Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15,000
- 试验地点
- 45
- 主要终点
- Sensitivity of the Avantect test
研究概览
简要总结
The goal of this interventional study is to evaluate if the novel diagnostic blood test, called Avantect can early detect pancreatic cancer in patients diagnosed with type 2 diabetes within the last 6 months.
Participants will:
- attend 3 study visits over 12 months time
- provide a blood sample at each study visit
- complete an anxiety questionnaire at each visit.
详细描述
Pancreatic cancer (PC) is one of the most lethal common cancers (five-year survival 5-7%). In more than 80% of patients the disease has spread before it is detected, ruling out potentially curative treatment options. Early detection offers the possibility of surgery leading to significantly improved overall survival.
There is currently no accepted screening test for pancreatic cancer. The Aventect test is designed to detect clues, or biomarkers for the presence or absence of pancreatic cancer signals in blood. The SAFE-D study will evaluate if the Avantect test can detect pancreatic cancer at an earlier more treatable stage.
People older than 50 years who have recently been diagnosed with type II diabetes have up to ten times higher-than-average risk of having pancreatic cancer without knowing.
The study will recruit up to 15,000 participants aged 50-84 years old diagnosed with type II diabetes within the last 6 months from GP practices over 3 years.
Participants will be randomly assigned to either the active intervention arm or the control arm for comparison. Intervention arm samples will be run on the Avantect test as soon as possible. If a pancreatic biomarker is detected the participants will be informed and offered a standard of care diagnostic imaging scan (MRI or CT) to rule out pancreatic cancer. Control arm samples will be stored for potential future Avantect testing or future research. All participants will be followed remotely via cancer and mortality registry searches for 3 years from consent to assess any cancer diagnosed during this time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 - 84 years of age at the time of enrolment (within year of birth, not month of birth)
- •Haemoglobin A1c (HbA1c) ≥ 48 or 6.5% and/or confirmed type II DM diagnosed within the last 180 days (+20 days flexibility allowance)
- •Willing to provide up to 30 mL of blood for each study visit
- •Willing and eligible to undergo MRI scan (or CT scan if MRI is contraindicated)
- •Understands the study process and is willing to take part in the study and sign the informed consent form
排除标准
- •Prior type I or type II DM diagnosis > 6 months
- •A history of pancreatic cancer, pancreatic neuroendocrine tumour (pNET) or Pancreatitis
- •Under investigation for pancreatic cancer / pancreatic cyst
- •Any known pancreatic surgery (not including ERCP), or other major surgery requiring anaesthesia within 3 months
- •Any invasive solid or haematological cancer in the past 3 years, including cancer recurrence after treatment in the last 3 years
- •Current chronic or acute oral or systemic steroid use within 3 months of initial HbA1c or diabetes diagnosis (estimate rather than accurate)
- •Blood transfusion within 1 month
- •Solid organ transplant recipient
- •Currently pregnant
- •Needing dialysis
结局指标
主要结局
Sensitivity of the Avantect test
时间窗: Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.
The proportion of participants in the intervention arm with one (or more) Avantect "detected" test result who have pancreatic cancer diagnosed via imging in relation to all individuals in the intervention arm who had pancreatic cancer diagnosed.
Specificity of the Avantect test
时间窗: Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.
The proportion of participants in the intervention arm with one or more Avantect "not detected" test results, and no Avantect "detected" results, who did not have a pancreatic cancer diagnosis in relation to all individuals in the intervention arm who did not have a pancreatic cancer diagnosis.
Resectability rate of pancreatic cancer
时间窗: Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.
The proportion of pancreatic cancers deemed resectable by the study MDT divided by the number of pancreatic cancers and will be compared between arms.
次要结局
- Stage shift(Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.)
- Positive Predictive Value (PPV) of Avantect test in detecting pancreatic cancer (PC)(Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.)
- Negative Predictive Value (NPV) of Avantect test in ruling out pancreatic cancer (PC)(Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.)
- Resection rate of pancreatic cancer(Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.)