Yorkshire kidney screening trial
| ISRCTN | ISRCTN18055040 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18055040 |
| IRAS number | 290336 |
| ClinicalTrials.gov number | NCT05005195 |
| Secondary identifying numbers | IRAS 290336 |
- Submission date
- 11/03/2021
- Registration date
- 14/04/2021
- Last edited
- 25/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
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.
Who can participate?
All participants attending the second scanning round (T2) of the Yorkshire Lung Screening Trial.
What does the study involve?
Participants will be invited by telephone to attend the YLST T2 scan. When they arrive at the YLST van they will be shown the YLST introduction video followed by the YKST video. The YLST consultation will then take place in a separate room. After the YLST components are completed, participants will be asked if they would like to take part in YKST. Participants wishing to take part, will be given the Participant Information Sheet and informed written consent will be sought. They will then be asked a small number of RCC specific questions (history of diabetes, high blood pressure, medication for high blood pressure, family history of kidney or pancreatic cancer, alcohol intake) before having the CT scan. For consenting participants, an abdominal CT scan will be conducted after the lung CT. Participants will not have to change position, and the abdominal scan will take an extra 10-15 seconds.
All participants approached to participate in YKST (both those who wish to take part as well as those who decline) will 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, or declining, to participate in YKST. Participants who do agree to take part in the interview study will be sent a separate Patient Information Sheet and consent form. A time and date convenient for the participant will then be arranged for a telephone or remote video interview.
What are the possible benefits and risks of participating?
For participants being offered YKST screening, the main benefit will be the potential to identify kidney cancers at an early stage, which can often be treated and cured. The CT scan may also pick up findings in the kidney which are not cancer but which require further investigations. Although the extra CT scan is being done to look at the kidneys, it will also include the upper abdomen, and may pick up problems in other organs, including the liver, pancreas and aorta. If such problems are detected, participants will be referred to the appropriate specialists.
CT scanners use radiation, which can itself cause problems (very rarely actually causing cancer), but by using very modern CT scanners we can reduce the amount of radiation needed. The extra CT scan of the kidneys will slightly increase the amount of radiation participants are exposed to. This extra dose is the same amount of radiation that participants would come into contact with in daily life, over a 12 month period. The likelihood of this scan detecting an early cancer is far greater than the likelihood of the scan causing harm.
Occasionally, people may have unnecessary investigations because findings later turn out to be benign (not cancer) or a harmless kidney cancer (that would not cause problems even if left alone).
Participants may feel anxious about what the scan may find, and about any further investigations they may need as a result of these findings. The doctors and nurses involved in the trial will always be available to discuss any concerns participants may have.
Where is the study run from?
The University of Cambridge, in close collaboration with the YLST team who are based in Leeds Teaching Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
February 2021 to April 2023
Who is funding the study?
Yorkshire Cancer Research (UK)
Who is the main contact?
Professor Grant Stewart, gds35@cam.ac.uk
Contact information
Scientific
University of Cambridge
Department of Surgery
Cambridge
CB2 0QQ
United Kingdom
 ORCID ID |
0000-0003-3188-9140 |
|---|---|
| gds35@cam.ac.uk |
Public
University of Cambridge
Department of Surgery
Cambridge
CB2 0QQ
United Kingdom
| ORCID ID |
0000-0003-0134-5564 |
|---|---|
| jk896@cam.ac.uk |
Study information
| Study design | Interventional non-randomized feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | 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. |
| Study acronym | YKST |
| Study hypothesis | This is a feasibility study aiming to pilot procedures required for a subsequent full-scale RCT of RCC screening by non-contrast CT scanning within lung cancer screening; investigating the take up of the abdominal CT scan to screen for RCC, acceptability of the intervention to patients and health care professionals, as well as logistics around delivering the intervention. |
| Ethics approval(s) | Approved 16/02/2021, North West - Preston Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8206; preston.rec@hra.nhs.uk), ref: 21/NW/0021 |
| Condition | Screening for renal cell carcinoma (RCC) in participants of the Yorkshire Lung Screening Trial |
| Intervention | Participants taking part in the study will be offered a non-abdominal CT scan at their T2 (2 years after baseline) YLST study visit. Participants taking part in the Yorkshire Lung Screening Trial (YLST) are invited to the T2 YLST study visit, either by telephone or letter, and a clinic appointment is arranged. When participants arrive on the mobile van for the YLST T2 visit, they are given an iPad to watch the YLST PIS video, after which they are informed of YKST and are invited to continue watching the YKST study PIS video. Participants then complete the YLST T2 consultation. If they would like to take part in YKST, participants are asked to sign the YKST consent form and complete a short YKST baseline questionnaire. Participants then leave the consultation room to have their lung non contrast CT scan, followed directly by the non-contrast abdominal CT scan. Participants then leave the mobile van. This all happens over 1 day. Results are feedback to participants within 2-4 weeks, and any findings that require follow up are done so by the relevant clinical team, as per Leeds Teaching Hospitals Trust standard clinical practice. Participants who consent to being contacted for an interview will be contacted (by email/phone/letter) by a YKST team member from the University of Cambridge and asked if they would like take part in an interview. If so, they will be sent the YKST interview PIS and asked for consent. An interview (either by video call or telephone) will be arranged at a time convenient to the participant and will last approximately 30 – 45 minutes. Relevant clinical outcomes will be followed up after 10 years (with the patients’ consent) by reviewing their patient notes. |
| Intervention type | Other |
| Primary outcome measure | 1.The proportion of individuals attending the T2 round of YLST who take up the offer of an abdominal CT scan measured using patient records, reports and study visit logs. Calculated at a single time point 2. The acceptability to participants of combined lung and RCC screening by non-contrast CT scanning measured using interviews within 3 months of the invitation to the study 3. The acceptability to healthcare professionals involved in the screening of combining RCC screening by non-contrast CT scanning with lung cancer screening measured using interviews within 6 months of study start 4, 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 measured using timing sheets at a single time point |
| Secondary outcome measures | Current secondary outcome measures as of 04/02/2022: 1. The proportion of participants found to have a renal mass or RCC measured using CT at a single time point 2. The stage distribution of RCC identified through non-contrast CT screening at a single time point 3. The proportion of participants found to have incidental renal findings (cysts, anatomical variants) on non-contrast CT scanning at a single time point 4. The proportion of participants with non-renal findings i.e. abdominal aortic aneurysms, pancreatic and liver lesions on non-contrast CT scanning at a single time point 5. The proportion of RCCs found on the upper pole of participants in T2 who did not have them in the T0 round, to estimate the incidence of RCC over sequential non-contrast LDCT scans Previous secondary outcome measures: 1. The proportion of participants found to have an RCC measured using CT at a single time point 2. The stage distribution of RCC identified through non-contrast CT screening at a single time point 3. The proportion of participants found to have incidental renal findings (cysts, anatomical variants) on non-contrast CT scanning at a single time point 4. The proportion of participants with non-renal findings i.e. abdominal aortic aneurysms, pancreatic and liver lesions on non-contrast CT scanning at a single time point |
| Overall study start date | 16/02/2021 |
| Overall study end date | 30/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 5,850 participants expected to be invited to non-contrast CT screening (as part of T2 round of the YLST) with a sub-set of up to 40 additionally taking part in qualitative interviews. 5 - 10 Health Care professionals will also be invited to take part in the qualitative interviews |
| Total final enrolment | 4019 |
| Participant inclusion criteria | The study is only open to participants of the Yorkshire Lung Screening Trial who are high risk for lung cancer as defined by one of the three criteria: 1. 30 pack year history of smoking and current smoker or quit within the last 15 years (USPSTF criteria) 2, Lung cancer risk of ≥1.51% over 6 years as calculated by the PLCOM2012 score 3. Lung cancer risk of ≥5% over 5 years as calculated by the LLPv2. score) |
| Participant exclusion criteria | 1. Have undergone CT Thorax within the previous 12 months 2. Unable to provide informed consent to study 3. Unable to have a chest or abdominal non-contrast CT scan 4. Previous diagnosis of kidney cancer 5. Have undergone abdominal CT scan in previous 6 months |
| Recruitment start date | 12/04/2021 |
| Recruitment end date | 31/10/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leeds
LS9 7TF
United Kingdom
Sponsor information
University/education
Faculty Research Office
Room 9.29, Level 9
Worsley Building
Clarendon Way
Leeds
LS2 9NL
England
United Kingdom
| Phone | +44 (0)1133437587 |
|---|---|
| governance-ethics@leeds.ac.uk | |
| Website | http://www.leeds.ac.uk |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- YCR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a high impact, peer-reviewed journal. |
| IPD sharing plan | In order to meet our ethical obligation to responsibly share data generated by clinical trials, YKST operates a transparent data sharing request process. Anonymous data will be available for request once the study has published the final proposed analyses. Researchers wishing to use the data will need to complete a Request for Data Sharing form describing a methodologically sound proposal. The form will need to include the objectives, what data are requested, timelines for use, intellectual property and publication rights, data release definition in the contract and participant informed consent etc. A Data Sharing Agreement from the Sponsor may also be required |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 20/09/2022 | 27/09/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 12/09/2024 | 25/09/2024 | Yes | No |
Editorial Notes
25/09/2024: Publication reference added and the IPD sharing plan summary was updated to include "stored in non-publicly available repository".
22/04/2024: The intention to publish date was changed from 30/04/2024 to 31/08/2024.
23/02/2024: The following changes were made:
1. A public contact was removed.
2. The intention to publish date was changed from 28/02/2024 to 30/04/2024.
31/10/2023: The total final enrolment was added.
24/04/2023: The trial manager confirmed no updates are required.
02/11/2022: Contact details updated.
19/10/2022: The following updates were made to the study record:
1. Contact details updated.
2. The overall trial end date was changed from 28/02/2023 to 30/04/2023.
27/09/2022: Publication reference added.
04/02/2022: The following changes have been made:
1. The secondary outcome measures have been updated.
2. The individual participant data (IPD) sharing statement has been added and the IPD sharing summary has been changed from "Data sharing statement to be made available at a later date" to "Available on request".
24/01/2022: The ClinicalTrials.gov number was added.
24/03/2021: Trial's existence confirmed by North West - Preston Research Ethics Committee
