CANcer DIagnosis Decision rules
| ISRCTN | ISRCTN43055332 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43055332 |
| Secondary identifying numbers | 13492 |
- 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
Plain English Summary
Contact information
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
| n.thompson@soton.ac.uk |
Study information
| Study design | Non-randomised observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | CANcer DIagnosis Decision rules: an observational study |
| Study acronym | CANDID |
| Study hypothesis | 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 |
| Condition | 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 | Participant appearing in cancer or mortality registries; Timepoint(s): up to 5 years post recruitment |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 31/01/2013 |
| Overall study end date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | UK Sample Size: 20000 |
| Participant inclusion criteria | Male and female over 35 with lung or colorectal symptoms |
| Participant exclusion criteria | 1. Already has a diagnosis of cancer 2. Unable to give informed consent |
| Recruitment start date | 31/01/2013 |
| Recruitment end date | 30/09/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SO16 5ST
United Kingdom
Sponsor information
University/education
Research Governance Office
George Thomas Building 37
Room 4055
Highfield
Southampton
SO17 1BJ
England
United Kingdom
| Website | http://www.southampton.ac.uk |
|---|---|
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Not provided at time of registration |
| 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? |
|---|---|---|---|---|---|
| Protocol file | version v4 | 03/07/2015 | 31/07/2020 | No | No |
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.
