Condition category
Cancer
Date applied
10/11/2010
Date assigned
08/12/2010
Last edited
08/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nereo Segnan

ORCID ID

Contact details

Via S Francesco da Paola 31
Turin
10123
Italy
nereo.segnan@cpo.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised controlled trial evaluating efficacy of 'one-only sigmoidoscopy' screening for colorectal cancer

Acronym

SCORE

Study hypothesis

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

Local co-ordinating committees approved following approval from the Delibera Azienda USL 1 Torino on the 14th June 1995 (ref: 982/07/95)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/10/1995

Overall trial end date

30/06/1998

Reason abandoned

Eligibility

Participant inclusion criteria

Eligible, interested respondents to a mail questionnaire sent to a random population sample of men and women aged 55 to 64 years.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40,000

Participant 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

Recruitment start date

01/10/1995

Recruitment end date

30/06/1998

Locations

Countries of recruitment

Italy

Trial participating centre

Via S Francesco da Paola 31
Turin
10123
Italy

Sponsor information

Organisation

Italian Association for Cancer Research (Associazione Italiana per la Ricerca sul Cancro [AIRC]) (Italy)

Sponsor details

Via Corridoni 7
Milano
20122
Italy
nereo.segnan@cpo.it

Sponsor type

Research organisation

Website

http://www.airc.it

Funders

Funder type

Research organisation

Funder name

Support for the study was provided by grants from:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Italian Association for Cancer Research (Associazione Italiana per la Ricerca sul Cancro [AIRC]) (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Italian National Research Council (CNR) (Italy) (ref: 95.00539.PF39, 96.00736.PF39)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The following provided additional resources for the implementation of the study in Rimini, Biella, Milano and Torino, respectively:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Romagnolo Cancer Institute (Istituto Oncologico Romagnolo [IOR]) (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Edo Tempia Fund (Fondo Edo Tempia) (Italy)

Alternative name(s)

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Funding Body Subtype

Location

Funder name

University of Milan (Università degli Studi di Milano) (Italy)

Alternative name(s)

Funding Body Type

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Location

Funder name

Local Health Unit (Azienda Sanitaria Locale [ASL]) 1, Torino (Italy)

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

2002 baseline findings in http://www.ncbi.nlm.nih.gov/pubmed/12464648

Publication citations

  1. Baseline findings

    Segnan N, Senore C, Andreoni B, Aste H, Bonelli L, Crosta C, Ferraris R, Gasperoni S, Penna A, Risio M, Rossini FP, Sciallero S, Zappa M, Atkin WS, , Baseline findings of the Italian multicenter randomized controlled trial of "once-only sigmoidoscopy"--SCORE., J. Natl. Cancer Inst., 2002, 94, 23, 1763-1772.

Additional files

Editorial Notes