Evaluation of colon cancer screening on colon cancer mortality
| ISRCTN | ISRCTN11768442 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11768442 |
| Secondary identifying numbers | HCB/2018/0109 |
- Submission date
- 01/02/2019
- Registration date
- 05/02/2019
- Last edited
- 26/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
C/ Ramón Trias-Fargas 25-27
Barcelona
08005
Spain
 ORCID ID |
0000-0001-8595-1224 |
|---|---|
| Phone | (+34) 93 542 1586 |
| miquel.serra@upf.edu |
Study information
| Study design | Observational natural experiment |
|---|---|
| Primary study design | Observational |
| Secondary study design | Natural Experiment |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | No participant information sheet available. |
| Scientific title | Impact of population screening on colorectal cancer mortality: a natural experiment |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Current primary outcome measure as of 25/02/2019: 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 50-69 years old. Previous 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 study start date | 02/01/2019 |
| Completion date | 28/02/2019 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | The entire population of Spain: 46000000 |
| Key inclusion criteria | The entire population of Spain |
| Key exclusion criteria | Resident of Spanish provinces that started screening after 2009. |
| Date of first enrolment | 10/01/2019 |
| Date of final enrolment | 30/01/2019 |
Locations
Countries of recruitment
- Spain
Study participating centre
Bacelona
08036
Spain
Sponsor information
University/education
C/ Ramón Trias-Fargas 25-27
Barcelona
08005
Spain
| Website | https://www.upf.edu/ |
|---|---|
"ROR" |
https://ror.org/04n0g0b29 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/03/2021 | 26/11/2020 | Yes | No |
Editorial Notes
26/11/2020: Publication reference added.
25/02/2019: The primary outcome measure was changed.
19/02/2019: The ethics approval was updated. Ethical approval granted on 19/02/2019.
