Italian multicentre randomised controlled trial of 'once-only sigmoidoscopy'
| ISRCTN | ISRCTN27814061 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27814061 |
| Protocol serial number | N/A |
| Sponsor | Italian Association for Cancer Research (Associazione Italiana per la Ricerca sul Cancro [AIRC]) (Italy) |
| Funders | Support for the study was provided by grants from:, Italian Association for Cancer Research (Associazione Italiana per la Ricerca sul Cancro [AIRC]) (Italy), Italian National Research Council (CNR) (Italy) (ref: 95.00539.PF39, 96.00736.PF39), The following provided additional resources for the implementation of the study in Rimini, Biella, Milano and Torino, respectively:, Romagnolo Cancer Institute (Istituto Oncologico Romagnolo [IOR]) (Italy), Edo Tempia Fund (Fondo Edo Tempia) (Italy), University of Milan (Università degli Studi di Milano) (Italy), Local Health Unit (Azienda Sanitaria Locale [ASL]) 1, Torino (Italy) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
To quantify the reduction in CRC incidence (measured at 10 years) and mortality (measured at 11 years). |
| Key secondary outcome measure(s) |
1. To determine the duration of efficacy of a single flexible sigmoidoscopy, measured up to 15 years from randomisation |
| Completion date | 30/06/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40000 |
| 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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? |
|---|---|---|---|---|---|
| Results article | 09/11/2021 | 10/11/2021 | Yes | No | |
| Other publications | baseline findings | 04/12/2002 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
