Condition category
Cancer
Date applied
10/07/2006
Date assigned
28/07/2006
Last edited
11/11/2009
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

CPO Piemonte and ASO San Giovanni Battista
Via San Francesco da Paola
31
Turin
10123
Italy
+39 011 633 3860
nereo.segnan@cpo.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SCORE 3 (Screening COloREctal)

Study hypothesis

Comparisons of attendance, detection rates and acceptability of total colonoscopy, flexible sigmoidoscopy and fecal occult blood test (FOBT) as primary screening tests for colorectal cancer.

Ethics approval

Piedmont region ethics board, date of approval: 17/06/2002 (ref: 8151/28.3)

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Condition

Colorectal cancer, colorectal polyps

Intervention

Patients, after informed consent, were individually randomized from rosters of GPs or from residents in specific districts or city neighborhoods, either to total colonoscopy or flexible sigmoidoscopy or FOBT.

1. Colonoscopy: oral bowel preparation with sodium phosphate solution (two litres). Mild dietary restrictions (i.e. to increase the uptake of water and to reduce consumption of foods rich in fibers the day before the test) recommended. Colonoscopy performed by gastroenterologists in hospital endoscopy units. No standard protocol for sedation. If the baseline colonoscopy could not be completed to the cecum, the patients were referred for a Double Contrast Barium Enema (DCBE), whenever advanced adenomas (see Polyp classification) were detected in the segments examined. DCBE was not routinely indicated in the case of a negative incomplete colonoscopy, due to patient's intolerance.

2. Sigmoidoscopy: bowel preparation was limited to a single enema (133 ml of 22% sodium phosphate) self-administered at home two hours before the test. No dietary restriction recommended. Screening undertaken by gastroenterologists in hospital endoscopy units. Aim of the examination: to advance the endoscope beyond the sigmoid-descending colon junction under adequate bowel preparation. Polyps smaller than 10 mm detected during the flexible sigmoidoscopy were removed immediately and sent for histological assessment. Subjects with polyps larger than or equal to 10 mm, as well as those detected with advanced adenomas (see polyp classification) referred for total colonoscopy. Subjects with suspected colorectal cancer or with polyps too large to be removed endoscopically referred for surgery.

3. FOBT: immunochemical test performed on a single sample without any dietary restriction. All cards stored at 4°C and shipped weekly to one central laboratory (Laboratorio di Citopatologia, CSPO - Florence). Patients with positive test called by the study staff and they are offered an appointment date for a total colonoscopy.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Attendance and detection rate to total colonoscopy, flexible sigmoidoscopy and FOBT as primary screening tests.

Secondary outcome measures

Acceptability, complication rates, side effects and costs associated with screening procedures.

Overall trial start date

01/10/2002

Overall trial end date

31/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Men and women aged 55 to 64 who had not been recruited in previous SCORE trials (SCORE and SCORE 2).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

18,000 subjects

Participant exclusion criteria

1. Patients unable to give informed consent
2. Patients with terminal illness, inflammatory bowel disease, personal history of polyps or colorectal cancer
3. Patients with two first degree relatives with colorectal cancer
4. Patients who had a colorectal endoscopy or FOBT within the previous two years

Recruitment start date

01/10/2002

Recruitment end date

31/01/2004

Locations

Countries of recruitment

Italy

Trial participating centre

CPO Piemonte and ASO San Giovanni Battista
Turin
10123
Italy

Sponsor information

Organisation

Italian League Against Cancer (LILT) (Italy)

Sponsor details

Via Torlonia
15
Rome
00161
Italy
+39 064 425 971
sede.nazionale@lilt.it

Sponsor type

Government

Website

www.lagatumori.it

Funders

Funder type

Government

Funder name

Support for the study was provided by:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Grant from the Italian League against Cancer (LILT) (Italy) (Letter protocol number: 2001/3081/Sa/lr)

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The following provided additional resources for the implementation of the study in Rimini, Biella, Milan, Verona and Turin, respectively:

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a. Piedmont Regional Health Authority (Italy)

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b. ULSS 20 Verona (Italy)

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c. University of Milan (Italy)

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d. Fondo "E Tempia" (Italy)

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e. Istituto Oncologico Romagnolo (IOR) (Italy)

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SOFAR s.p.a. (Italy) provided the enemas for the bowel preparation

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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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17570205

Publication citations

  1. Results

    Segnan N, Senore C, Andreoni B, Azzoni A, Bisanti L, Cardelli A, Castiglione G, Crosta C, Ederle A, Fantin A, Ferrari A, Fracchia M, Ferrero F, Gasperoni S, Recchia S, Risio M, Rubeca T, Saracco G, Zappa M, , Comparing attendance and detection rate of colonoscopy with sigmoidoscopy and FIT for colorectal cancer screening., Gastroenterology, 2007, 132, 7, 2304-2312, doi: 10.1053/j.gastro.2007.03.030.

Additional files

Editorial Notes