Yorkshire Kidney Screening Trial (YKST): a Feasibility Study of Adding Non-contrast Abdominal CT Scan to Chest CT Scan Undertaken in the YLST Randomised Controlled Trial of Community-based CT Screening for Lung Cancer in an at Risk Population to Screen for RCC and Other Abdominal Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,850
- 试验地点
- 2
- 主要终点
- The proportion of individuals who take up the offer of an abdominal CT scan
研究概览
简要总结
Kidney cancer is the 8th most common cancer in Yorkshire. It has a poor survival rate, with only 6 out of 10 patients diagnosed with kidney cancer still alive after 5 years. This is partly because many people with kidney cancer don't have any symptoms. In some of these people, kidney cancer is only found by chance during investigations for other reasons. In others, it is often not diagnosed until the disease has passed the point at which we can easily cure it.
Screening for kidney cancer has the potential to pick up these cancers earlier and increase the number of people who can be cured. The Yorkshire Lung Screening Trial offers people aged 55-80 with a history of smoking a CT scan as part of a lung health check. This group of people is also at increased risk of developing kidney cancer. Our new study, the Yorkshire Kidney Screening Trial, will piggyback on this trial to offer an extra CT scan for kidney cancer. The extra scan will take 10 seconds. By the end of the study we will understand whether it is workable to roll this out more widely and whether people take up this extra scan.
详细描述
Background to YLST and link with YKST
YKST will be offered to participants of YLST. In brief, YLST is a community-based screening programme funded by Yorkshire Cancer Research which uses mobile units across Leeds through a Zelen's design study, allowing assessment of the overall effect of screening Yorkshire people who are current smokers or ex-smokers and therefore at high-risk for lung cancer. YLST is one of the World's largest lung cancer screening trials and nesting YKST within this on-going trial provides a unique opportunity to both add value to this existing trial and provide much needed data relating to future RCC screening.
In YLST, ~45,000 people were invited to participate in the study with 6,892 eventual participants estimated to attend for the first of two rounds of low-dose CT (LDCT) screening (called T0 and T2 respectively). To identify eligible individuals, General Practices within the Leeds CCG area provided consent for interrogation of their Primary Care databases
At the first Lung Health Check (T0) relevant clinical and demographic information were collected and participants were offered a LDCT scan either immediately or to return another day at their preference. Two years later the participants who attended for an initial Lung Health Check are invited back for a follow-up Lung Health Check (T2) which includes a second LDCT scan. In YKST we are asking participants in this T2 round of YLST, from 10 May 2021 to 31 Oct 2022, to undergo an abdominal CT scan in addition to the repeated CT chest.
Participant pathway and detailed logistics
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
There is no randomisation in this study.
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Have undergone CT Thorax within the previous 6 months
- •Unable to provide informed consent to study
- •Unable to have a chest or abdominal non-contrast CT scan
- •Previous diagnosis of kidney cancer
- •Have undergone abdominal CT scan in previous 6 months
结局指标
主要结局
The proportion of individuals who take up the offer of an abdominal CT scan
时间窗: At the end of the 18 month recruitment period
The proportion of individuals attending the T2 round of YLST who take up the offer of an abdominal CT scan
The acceptability of the combined lung and RCC screening approach to participants
时间窗: On completion of the patient interview analysis - by the end of the 18 month recruitment period
The acceptability to participants of combined lung and RCC screening by non-contrast CT scanning - ascertained by interviews
The acceptability of the combined lung and RCC screening approach to healthcare professionals
时间窗: On completion of the health care professional interview analysis - by the end of the 18 month recruitment period
The acceptability to healthcare professionals involved in the screening of combining RCC screening by non-contrast CT scanning with lung cancer screening - ascertained by interviews
The additional time required for the combined screening approach
时间窗: On completion of the study process observation analysis - by the end of the 18 month recruitment period
The additional time required for the combined screening approach, including the time to provide information, consent participants, and perform the lengthier CT scan, the time needed by radiologists for reporting the CT scans, and the additional time to review abdominal CT findings
次要结局
- The proportion of participants found to have incidental renal findings(At the end of the 18 month recruitment period)
- The proportion of participants with non-renal findings(At the end of the 18 month recruitment period)
- Estimation of the incidence of RCC(At the end of the 18 month recruitment period)
- Estimate of the prevalence of RCC(At the end of the 18 month recruitment period)
- The stage distribution of all RCCs identified, reported as cancer findings with TNM(At the end of the 18 month recruitment period)
研究者
Professor Grant Stewart
Principal Investigator
University of Leeds