Condition category
Cancer
Date applied
01/02/2019
Date assigned
05/02/2019
Last edited
19/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The impact of colorectal cancer population screening strategies on mortality outside of randomized controlled trials remains unknown. The objective of this study was to measure the mid-term impact of the introduction of colorectal cancer screening programmes on colorectal cancer mortality rates across Spain.

Who can participate?
The entire population of Spain

What does the study involve?
The research team review the number of deaths by colon cancer by reviewing Spanish Statistical Office data of mortality recorded in a database every 6 months for the 17-year study period. Information about the screening implementation and uptake is also observed using from regional registries.

What are the possible benefits and risks of participating?
There are no direct benefits or risks incolved with participating

Where is the study run from?
Hospital Clínic de Barcelona (Spain)

When is the study starting and how long is it expected to run for?
January 2019 to February 2019.

Who is funding the study?
Investigator-initiated and funded.

Who is the main contact?
Miquel Serra-Burriel
miquel.serrab@upf.edu

Trial website

Contact information

Type

Scientific

Primary contact

Mr Miquel Serra-Burriel

ORCID ID

http://orcid.org/0000-0001-8595-1224

Contact details

C/ Ramón Trias-Fargas 25-27
Barcelona
08005
Spain
(+34) 93 542 1586
miquel.serra@upf.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HCB/2018/0109

Study information

Scientific title

Impact of population screening on colorectal cancer mortality: a natural experiment

Acronym

Study hypothesis

1. Has the implementation of colorectal cancer screening in Spanish provinces that adopted it been effective in reducing colorectal cancer mortality?
2. Has the implementation of colorectal cancer screening in Spanish provinces had a differential effect by gender?

Ethics approval

Approved 19/02/2019 Ethics Committee, Hospital Clínic de Barcelona (Villarroel, 170, 08036 Barcelona, Spain; +34 93 227 57 66; ceic@clinic.cat), ref HCB/2018/0109.

Study design

Observational natural experiment

Primary study design

Observational

Secondary study design

Natural Experiment

Trial setting

Other

Trial type

Other

Patient information sheet

No participant information sheet available.

Condition

Colorectal cancer

Intervention

The present study is an ecological analysis of colorectal cancer-specific deaths at a province level. We compare age-standardised mortality rates in provinces that were exposed to screening with provinces that did not.

The individual's data comes from the Spanish Statistical Office, and only includes death certificate data combined with population census data at a province level. The data was obtained through the INE
https://www.ine.es/dyngs/INEbase/es/operacion.htm?c=Estadistica_C&cid=1254736176780&menu=resultados&secc=1254736195294&idp=1254735573175

Intervention type

Other

Phase

Drug names

Primary outcome measure

Mortality rates will be measured using the biannual CRC-specific 1999 age-standardised mortality rates (measured by the National Statistical Office of Spain) for the population aged 50-79 years old.

Secondary outcome measures

1. Biannual CRC-specific 1999 Age-standardised mortality rates for overall population, measured by the National Statistical Office of Spain (INE)
2. Biannual CRC-specific 1999 Age-standardised mortality rates for population aged between 40 to 49 years old, measured by the National Statistical Office of Spain (INE)
3. Biannual CRC-specific 1999 Age-standardised mortality rates for population aged between 0 to 39 years old, measured by the National Statistical Office of Spain (INE)

Overall trial start date

02/01/2019

Overall trial end date

28/02/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

The entire population of Spain

Participant type

All

Age group

All

Gender

Both

Target number of participants

The entire population of Spain: 46000000

Participant exclusion criteria

Resident of Spanish provinces that started screening after 2009.

Recruitment start date

10/01/2019

Recruitment end date

30/01/2019

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Clínic de Barcelona
Villarroel, 170
Bacelona
08036
Spain

Sponsor information

Organisation

Pompeu Fabra University

Sponsor details

C/ Ramón Trias-Fargas 25-27
Barcelona
08005
Spain

Sponsor type

University/education

Website

https://www.upf.edu/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of findings as an academic paper in a high-ranking, open access medical journal. After publication, a press release will be created that is accessible to all with assistance from the Pompeu Fabra University external communications team. Results will also be presented at national and international public health conferences.

IPD sharing statement: due to compliance with the Spanish Statistical Office regulation, data will not be available at the end of the study, but can be accessed through: https://www.ine.es/welcome.shtml.

Intention to publish date

01/04/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

19/02/2019: The ethics approval was updated. Ethical approval granted on 19/02/2019.