CANcer DIagnosis Decision rules

ISRCTN	ISRCTN43055332
DOI	https://doi.org/10.1186/ISRCTN43055332
Protocol serial number	13492
Sponsor	University of Southampton (UK)
Funder	National School for Primary Care Research (UK)

Submission date: 12/12/2012
Registration date: 12/03/2013
Last edited: 20/03/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-study-help-gps-decide-sooner-who-needs-tested-lung-or-bowel-cancer-candid

Contact information

Ms Natalie Thompson
Scientific

PhD Student, Research Programme Manager - The STREAM Study, Archivist (PCPS) & Mental Health First Aider
School of Primary Care, Population Sciences and Medical Education
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Email	n.thompson@soton.ac.uk

Study information

Primary study design	Observational
Study design	Non-randomised observational cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	CANcer DIagnosis Decision rules: an observational study
Study acronym	CANDID
Study objectives	This study seeks to work out which of the symptoms and examination findings are the most effective in the early prediction of lung or colon cancer. The aim is to recruit up to 20,000 patients who consult their GP half with lung symptoms and the other half with colorectal symptoms. Clinical information will be collected using standardised internet based forms. The clinical prediction 'rules' or decision aids developed from these studies will then be tested, with 2000 patients for each condition, for validity.
Ethics approval(s)	South Central Oxford A, 31/07/2012, ref: 12/SC/0328
Health condition(s) or problem(s) studied	Cancer / primary care study
Intervention	Willing patients will complete lifestyle questionnaires and provide blood or saliva samples (including for genetic analysis). A notes review will also be undertaken. The National Cancer and Mortality Registries will then be monitored to see which patients develop cancer, and statistical analysis will determine the most important clinical variables that predict cancer. Follow Up Length: 60 month(s)
Intervention type	Other
Primary outcome measure(s)	Participant appearing in cancer or mortality registries; Timepoint(s): up to 5 years post recruitment
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/12/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	20000
Key inclusion criteria	Male and female over 35 with lung or colorectal symptoms
Key exclusion criteria	1. Already has a diagnosis of cancer 2. Unable to give informed consent
Date of first enrolment	31/01/2013
Date of final enrolment	30/09/2017

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Aldermoor Health Centre

Southampton
SO16 5ST
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version v4	03/07/2015	31/07/2020	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN43055332_Protocol_v4_03Jul2015.pdf: Uploaded 31/07/2020

Editorial Notes

20/03/2025: The study contact was updated.
21/06/2022: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/12/2021 to 31/12/2022.
2. The intention to publish date was changed from 30/06/2022 to 30/06/2023.
17/03/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/03/2021 to 31/12/2021.
2. The intention to publish date was changed from 30/09/2021 to 30/06/2022.
14/09/2020: The overall trial end date has been changed from 30/09/2020 to 31/03/2021.
31/07/2020: The following changes have been made:
1. The IPD sharing statement has been added.
2. The trial website has been added.
3. The intention to publish date has been added.
4. Uploaded protocol Version 4 03 July 2015 (not peer reviewed).
5. The scientific contact details have been updated.
26/03/2018: Recruitment end date was changed from 31/03/2017 to 31/09/2017 and overall trial end date was changed form 31/03/2017 to 30/09/2020.
16/01/2017: the overall trial end date was changed from 31/01/2016 to 31/03/2017.