Condition category
Cancer
Date applied
12/12/2012
Date assigned
12/03/2013
Last edited
09/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mrs Susan Broomfield

ORCID ID

Contact details

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
seb4@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13492

Study information

Scientific title

CANcer DIagnosis Decision rules: an observational 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.

We aim 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.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13492

Ethics approval

Ethics Committee is South Central Oxford A, First MREC approval date 31/07/2012, ref: 12/SC/0328

Study design

Non-randomised observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

Participant appearing in cancer or mortality registries; Timepoint(s): up to 5 years post recruitment

Secondary outcome measures

No secondary outcome measures

Overall trial start date

31/01/2013

Overall trial end date

31/01/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Male and female over 35 with lung or colorectal symptoms

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 20000

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

31/01/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Medical Care
Southampton
SO16 5ST
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

Research Governance Office
George Thomas Building 37
Room 4055
Highfield
Southampton
SO17 1BJ
United Kingdom

Sponsor type

University/education

Website

http://www.southampton.ac.uk

Funders

Funder type

Government

Funder name

National School for Primary Care Research (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes