Italian multicentre randomised controlled trial of 'once-only sigmoidoscopy'
| ISRCTN | ISRCTN27814061 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27814061 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/11/2010
- Registration date
- 08/12/2010
- Last edited
- 10/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Nereo Segnan
Scientific
Scientific
Via S Francesco da Paola 31
Turin
10123
Italy
| nereo.segnan@cpo.it |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised controlled trial evaluating efficacy of 'one-only sigmoidoscopy' screening for colorectal cancer |
| Study acronym | SCORE |
| Study objectives | The incidence of distal adenomas reaches a plateau at around age 60 years. Therefore, a single sigmoidoscopy followed by colonoscopy in people with high-risk distal adenomas may offer a long lasting protection. |
| Ethics approval(s) | Local co-ordinating committees approved following approval from the Delibera Azienda USL 1 Torino on the 14th June 1995 (ref: 982/07/95) |
| Health condition(s) or problem(s) studied | Colorectal cancer screening |
| Intervention | Sigmoidoscopy offered once in the life in the intervention group; usual care in the control group. Sigmoidoscopy: Bowel preparation was limited to a single enema (133 ml of 22% sodium phosphate) self-administered at home 2 hours before the test. No dietary restriction recommended. Screening undertaken by gastroenterologists in hospital endoscopy units. Aim of the examination was to advance the endoscope beyond the sigmoid-descending colon junction under adequate bowel preparation. Polyps less than 6 mm detected during the FS were removed immediately and sent for histological examination. Subjects with polyps larger than 5 mm, or with advanced adenomas (see polyp classification) referred for TC. Subjects with suspected CRC or with polyps too large to be removed endoscopically referred for surgery. Joint sponsor details: Italian National Research Council (CNR) (Italy) Piazzale Aldo Moro, 7 00185, Roma Italy T: +39 (0)6 49 931 F: +39 (0)6 44 619 54 E: cnr@pec.cnr.it http://www.cnr.it |
| Intervention type | Other |
| Primary outcome measure | To quantify the reduction in CRC incidence (measured at 10 years) and mortality (measured at 11 years). |
| Secondary outcome measures | 1. To determine the duration of efficacy of a single flexible sigmoidoscopy, measured up to 15 years from randomisation 2. To determine the optimum age for the examination, measured at 10 and 11 years 3. To assess acceptability and organisational impact (evaluated in the recruitment phase) |
| Overall study start date | 01/10/1995 |
| Completion date | 30/06/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40,000 |
| Total final enrolment | 34272 |
| Key inclusion criteria | Eligible, interested respondents to a mail questionnaire sent to a random population sample of men and women aged 55 to 64 years. |
| Key exclusion criteria | 1. Personal history of colorectal cancer, adenomas, inflammatory bowel disease, recent colorectal endoscopy 2. Subjects mentioning two first-degree relatives with colorectal cancer 3. Subjects unable to give informed consent |
| Date of first enrolment | 01/10/1995 |
| Date of final enrolment | 30/06/1998 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via S Francesco da Paola 31
Turin
10123
Italy
10123
Italy
Sponsor information
Italian Association for Cancer Research (Associazione Italiana per la Ricerca sul Cancro [AIRC]) (Italy)
Research organisation
Research organisation
Via Corridoni 7
Milano
20122
Italy
| nereo.segnan@cpo.it | |
| Website | http://www.airc.it |
"ROR" |
https://ror.org/02g2x7380 |
Funders
Funder type
Research organisation
Support for the study was provided by grants from:
No information available
Italian Association for Cancer Research (Associazione Italiana per la Ricerca sul Cancro [AIRC]) (Italy)
No information available
Italian National Research Council (CNR) (Italy) (ref: 95.00539.PF39, 96.00736.PF39)
No information available
The following provided additional resources for the implementation of the study in Rimini, Biella, Milano and Torino, respectively:
No information available
Romagnolo Cancer Institute (Istituto Oncologico Romagnolo [IOR]) (Italy)
No information available
Edo Tempia Fund (Fondo Edo Tempia) (Italy)
No information available
University of Milan (Università degli Studi di Milano) (Italy)
No information available
Local Health Unit (Azienda Sanitaria Locale [ASL]) 1, Torino (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | baseline findings | 04/12/2002 | Yes | No | |
| Results article | 09/11/2021 | 10/11/2021 | Yes | No |
Editorial Notes
10/11/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
