Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05005195 |
| Other study ID # |
290336 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 10, 2021 |
| Est. completion date |
April 30, 2023 |
Study information
| Verified date |
November 2022 |
| Source |
University of Leeds |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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
There are 2 major elements to the logistics of YKST: 1) Obtaining the abdominal CT scan. From
invitation to completion of the CT scan, the existing YLST infrastructure will be used on the
YLST van. 2) Downstream processes from the scan. Reporting of the CT scan, informing
participants of results and dealing with anomalies. These are new YKST specific processes,
separate to YLST. Invitation YLST participants will receive a telephone call to book a T2
round appointment. Following this they will receive an appointment letter. If the participant
is not available after 2 attempted telephone calls, they are sent a pre-booked appointment.
Consent
On arriving on the YLST van the potential participants will watch the YLST T2 introduction
video. Following the YLST T2 introduction video the YKST PIS video will play, this will have
been mentioned to YLST participants by van staff on arrival . They will then have the YLST
consultation in a private consultation room. After completing the YLST components, they will
be asked if they wish to participate in YKST. For those wishing to take part, written consent
will be taken whilst in the consultation room and a small number of extra RCC specific
questions will be.
Those not wishing to take part will also be asked to give their reasons for declining and
asked if they consent to be contacted by a University of Cambridge researcher to discuss
taking part in a qualitative interview about their reasons for declining.
Those wishing to have the additional scan will also be asked if they consent to be contacted
by a University of Cambridge researcher to discuss taking part in a qualitative research
interview about reasons for agreeing to participate. Participants consenting to be contacted
by the research team about an interview (those wishing to have the additional scan and those
declining the scan) will be sent a separate PIS and a consent form and asked to contact the
team if they would like to take part. A member of the research team will then contact them to
arrange a convenient time for a telephone or remote video interview. Those taking part will
be asked to sign the consent form and send this back to the research team in a stamped
addressed envelope, or sign it electronically. In case there is a delay in this process,
possibly due to the COVID19 pandemic, verbal consent will also be taken over the telephone at
the start of the interview.
All healthcare professionals involved in the screening process will also be invited by the
research team to take part in an interview about the acceptability of the combined approach
and the logistics. They will be provided with a PIS and consent form and consent taken as for
screening participants above.
CT scanning protocol and reporting
Following confirmation that the participant has not has an abdominal CT scan within the
previous 6 months, scans will be ordered by the YKST nurse research team or research fellow.
We have designed a clear risk mitigation process to ensure that if a participant wishes to
continue with lung screening as part of YLST but does not want to participate in the YKST
component, that they do not get the abdominal CT scan. The mechanism for this is that a hard
copy of the Kidney Screening CT request form will only be printed once participants have
signed the YKST consent form. As an additional check the radiographers will be asked to sign
the request form to indicate that they have seen the YKST consent form before proceeding to
the additional kidney screening scan. This will act as an additional prompt for the
radiographer team to ensure that the correct screening protocols are used.
The abdominal CT scan will be performed immediately following the CT chest for YLST, the
patient will remain lying the CT scanner gantry and the abdominal CT will take a further 10
seconds to be performed.
Management of screening results
The Lead Consultant Radiologist and the YKST Principal Investigator (a Consultant
Urologist)at Leeds Teaching Hospitals NHS Trust have developed a series of pathways for
flagging in the CT report, based on: 1 - Normal; 2 - benign urological finding; 3 -
Indeterminate benign finding (i.e. cholecystitis/pancreatitis); 4 Possible malignancy outside
renal tract (2 week wait referral) or AAA (referral to vascular surgery); 5 - Possible
renal/urological cancer (2 week wait referral).
The PI will work with the nurse practitioner and administration support employed by YKST for
the duration of the scanning period so that they can inform the patients of results and refer
patients to the appropriate other specialities: e.g. vascular and HPB surgery There are no
further visits of assessments for participants of YKST.
Qualitative interviews and ethnography
We will conduct semi-structured qualitative telephone or remote video interviews within 3
months of the initial study invitation with a purposive sample of both participants who take
up the additional abdominal CT scan and those who decline the additional scan. The interviews
will explore their views on the acceptability of the combined screening approach, the consent
process, the information provided about the additional scan, and their reasons for accepting
or declining the scan. We will also explore potential psychological harms, for example,
increased anxiety or worry related to the additional scan or the information provided about
kidney cancer and other potential abdominal findings. We will draw on the principles of
information power when deciding when to cease data collection but anticipate interviewing up
to 40 participants. We will purposefully sample participants with the aim to include
approximately 20 who took up the additional scan and 20 who did not and to include
participants with a range of ages, sex, and abdominal findings. Interviews will be recorded
and transcribed for analysis. We expect interviews to last between 30-45 minutes.
To assess the study processes, including ordering the scans, obtaining consent, ensuring only
participants consenting to the additional abdominal scan receive it, performing, reporting
and reviewing the additional scans and feeding back the results, from the perspective of the
healthcare professionals we will also conduct telephone/video link interviews with key
individuals involved in the screening pathway. These will include CTAs, research nurses,
radiographers, radiologists and the triaging urologist. The interview schedule will cover
their views on all stages of the pathway relevant to them.
To explore in more detail the consent and scanning process on the screening vans, we will
also conduct an ethnographic study with a researcher spending time on the vans observing the
patient flow and processes. The field notes from these observations will be combined with the
analysis of the interview data to enable us to identify aspects that worked well and any
challenges or potential safety concerns within the proposed combined screening pathway in
order to inform a future RCT.
