An Interventional Study to Evaluate the cfDNA Pancreatic Cancer Test (Avantect) in the Early Detection of Pancreatic Cancer in Participants With Newly Diagnosed Diabetes Mellitus or Newly Elevated HbA1c
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 54
- 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 or with elevated sugar levels within the last 200 days.
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 5,000 participants aged 50-84 years old diagnosed with type II diabetes or elevated Hb1Ac levels within the last 200 days from GP practices over 3 years.
Participants will have their blood samples analysed 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. 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
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None (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)
- •Confirmed type 2 DM diagnosis established within the last 200 days or an initial elevated HbA1c ≥ 48 mmol/mol or 6.5% obtained within the last 200 days. This includes people who have a first elevated HbA1c (≥ 48 mmol/mol or 6.5%) within the last 200 days, even if subsequent HbAc1 measurements return to the the normal range.
- •Willing to provide up to 30 mL of blood for each study visit
- •Willing and eligible to undergo MRI or CT scan
- •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 or an initial HbA1c ≥ 48 mmol/mol or 6.5% obtained prior to the 200-day inclusion window, except gestational elevated HbA1c.
- •A history of pancreatic cancer, pancreatic neuroendocrine tumour (pNET) or Pancreatitis
- •Under investigation for or confirmed pancreatic cancer
- •Under investigation/surveillance for 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
- •BMI > 40 at the time of consent
- •Blood transfusion within 1 month
- •Solid organ transplant recipient
- •Currently pregnant
- •Needing dialysis
研究组 & 干预措施
Interventional
Participants will have their blood samples tested on the Avantect test within prioritised timeframe. The "detected" Avantect test results will be shared with the participants and their General Practitioners (GPs) to allow for further MRI or CT investigations by the local clinical team.
干预措施: Avantect Pancreatic Cancer Test (Device)
结局指标
主要结局
Sensitivity of the Avantect test
时间窗: The final analysis will be carried out after 3-year follow up data has been collected for all 5,000 participants.
The proportion of individuals with one or more Avantect "detected" test result who have pancreatic cancer diagnosed via imaging in relation to all individuals in the study who had pancreatic cancer diagnosed.
Specificity of the Avantect test
时间窗: The final analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.
The proportion of individuals 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 study who did not have a pancreatic cancer diagnosis.
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.
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.
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(The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.)
- Positive Predictive Value (PPV) of Avantect test in detecting pancreatic cancer (PC)(The final analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.)
- Negative Predictive Value (NPV) of Avantect test in ruling out pancreatic cancer (PC)(The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.)
- Resection rate of pancreatic cancer(The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.)
- Resectability(The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.)
- 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.)