NCT05005195

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,850

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

November 2, 2022

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

August 4, 2021

Last Update Submit

November 1, 2022

Conditions

Keywords

ScreeningFeasibility study

Outcome Measures

Primary Outcomes (4)

  • The proportion of individuals who take up the offer of an abdominal CT scan

    The proportion of individuals attending the T2 round of YLST who take up the offer of an abdominal CT scan

    At the end of the 18 month recruitment period

  • The acceptability of the combined lung and RCC screening approach to participants

    The acceptability to participants of combined lung and RCC screening by non-contrast CT scanning - ascertained by interviews

    On completion of the patient interview analysis - by the end of the 18 month recruitment period

  • The acceptability of the combined lung and RCC screening approach to healthcare professionals

    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

    On completion of the health care professional interview analysis - by the end of the 18 month recruitment period

  • The additional time required for the combined screening approach

    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

    On completion of the study process observation analysis - by the end of the 18 month recruitment period

Secondary Outcomes (5)

  • 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

  • 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

Study Arms (1)

Abdominal CT Scan

OTHER

A policy of invitation to a targeted community-based non-contrast CT screening of the abdomen in those at risk of kidney cancer.

Radiation: Low dose abdominal computed tomography scan

Interventions

A policy of invitation to a targeted community-based non-contrast CT screening of the abdomen in those at risk of kidney cancer

Abdominal CT Scan

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • High risk for lung cancer as defined by one of the three criteria:
  • pack year history of smoking and current smoker or quit within the last 15 years (USPSTF criteria).
  • Lung cancer risk of ≥1.51% over 6 years as calculated by the PLCOM2012 score.
  • Lung cancer risk of ≥5% over 5 years as calculated by the LLPv2. score.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leads Teaching Hospitals Trust

Leeds, Yorkshire, LS1 3EX, United Kingdom

Location

Related Publications (2)

  • Thomas C, Heathcote L, Sun Y, Callister MEJ, Kitt J, Rossi SH, Shinkins B, Usher-Smith JA, Whyte S, Stewart GD; YKST Study Group. Cost-effectiveness of one-off upper abdominal CT screening as an add-on to lung cancer screening in England. Br J Cancer. 2025 Aug;133(2):239-247. doi: 10.1038/s41416-025-03043-z. Epub 2025 May 14.

  • Usher-Smith JA, Godoy A, Burge SW, Burbidge S, Cartledge J, Crosbie PAJ, Eckert C, Farquhar F, Hammond D, Hancock N, Iball GR, Kimuli M, Masson G, Neal RD, Rogerson S, Rossi SH, Sala E, Smith A, Sharp SJ, Simmonds I, Wallace T, Ward M, Callister MEJ, Stewart GD. The Yorkshire Kidney Screening Trial (YKST): protocol for a feasibility study of adding non-contrast abdominal CT scanning to screen for kidney cancer and other abdominal pathology within a trial of community-based CT screening for lung cancer. BMJ Open. 2022 Sep 20;12(9):e063018. doi: 10.1136/bmjopen-2022-063018.

Related Links

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Grant D Stewart

    University of Cambridge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
There is no randomisation in this study.
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: A non-randomised feasibility study of adding non-contrast CT scanning of the abdomen to the CT chest undertaken in the T2 round of YLST. YLST is a two-arm, (1:1) implementation study using a single-consent Zelen's randomised controlled design. Participants have already been randomised to intervention (invitation to an initial telephone-based riskassessment and then, if eligible, for a Lung Health Check (LHC) which is carried out on a mobile van and incorporates LDCT scanning for lung cancer) or usual care (no invitation).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 13, 2021

Study Start

May 10, 2021

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

November 2, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations