Condition category
Cancer
Date applied
26/11/2014
Date assigned
05/12/2014
Last edited
04/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Five to ten percent of all cases of colorectal cancer (CRC) are caused by a combination of hereditary and environmental factors; these cases are collectively referred to as ‘familial CRC’. Colonoscopic surveillance is recommended for individuals with familial CRC. However, the appropriate screening interval (between colonoscopic examinations) has not yet been determined. The aim of this study was to compare a 3-year with a 6-year screening interval.

Who can participate?
500 adults aged 45-65, with a family history of CRC.

What does the study involve?
Participants will get a colonoscopy at enrollment in the study to determine if they have certain types of polyps (adenomas) that could become cancerous. These will be removed. If participants have 3 or more adenomas, next colonoscopies will be scheduled after 3 and 6 years. If participants have 0, 1 or 2 adenomas, they are randomly assigned to 2 study groups: follow-up colonoscopy in group A will be scheduled after 6 years, while in group B follow-up colonoscopies will be scheduled after 3 and 6 years. Comparisons between the groups A and B will be made for the presence of advanced adenomas (which have a higher potential of becoming cancerous but are not yet cancerous). This will help us define the interval to recommend between 2 colonoscopies.

What are the possible benefits and risks of participating?
The possible benefit for participants is that, if found at colonoscopy, adenomas from the colon are removed before cancer has developed. This study will also show for this type of population with a family history of CRC whether a 6-yearly interval between examinations/colonoscopies is safe (instead of having a colonoscopy every 3 years).
Possible risks are complications of colonoscopy. However, these risks of perforation and bleeding are very low. Participants are instructed when to contact the hospital again. Also, when the procedure was difficult or complicated, participants are kept under observation in hospital after the procedure (and if needed, treated).

Where is the study run from?
The FACTS study has been set up by the Leiden University Medical Center. Colonoscopies are also performed at collaborating national hospitals in the Netherlands.

When is the study starting and how long is it expected to run for?
Recruitment took place in 2002-2007. The study run for 6 years after inclusion of the last participant in 2007 until mid-2013.

Who is funding the study?
Netherlands Organisation for Health Research and Development.

Who is the main contact?
Professor Hans Vasen
hfavasen@stoet.nl

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hans Vasen

ORCID ID

Contact details

Rijnsburgerweg 10
Leiden
2333 AA
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P02.070

Study information

Scientific title

Randomized comparison of surveillance intervals in Familial Colorectal Cancer:
The Dutch FAmilial ColorecTal cancer Surveillance study (the FACTS study) Group

Acronym

FACTS

Study hypothesis

The aim of this randomized trial was to compare a 3-year with a 6-year screening interval. The hypothesis was that a 6-year screening interval is safe.

Ethics approval

Committee of Medical Ethics at the Leiden University Medical Center, 22/08/2002, ref: P02.070

Study design

Multicentre randomized trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Condition

Colorectal cancer (CRC)

Intervention

Based on the results of the baseline colonoscopy, patients were assigned to different study groups (group A and B). Patients who had 3 or more adenomatous polyps at baseline were excluded and were scheduled for a follow-up colonoscopy at 3 years. Patients with 0, 1 or 2 adenomatous polyps at baseline were randomized into two groups: group A underwent colonoscopy at 6 years, while group B underwent follow-up colonoscopies at 3 and 6 years.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Presence of adenoma with advanced pathology (AAP), defined as an adenoma with either high grade dysplasia, (tubulo)villous architecture or a size ≥ 1 cm in diameter. This is measured at timepoint 6 years in group A, and at timepoints 3 and 6 years in group B. Polyps are removed during colonoscopies at these timepoints and are revised by one pathologist for characteristics of AAP.

Secondary outcome measures

Presence of adenomas.
This is measured at timepoint 6 years in group A, and at timepoints 3 and 6 years in group B. Polyps are removed during colonoscopies at these timepoints and are revised by one pathologist for characteristics of adenomas.

Overall trial start date

01/01/2002

Overall trial end date

01/09/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Individuals aged between 45 and 65 years,
2. A positive family history for colorectal cancer (CRC), i.e., one first-degree relative (FDR) diagnosed with CRC <50 years, or two FDRs diagnosed with CRC at any age.

Subjects were excluded if they had 3 or more adenomas at baseline colonoscopy, while those with 0-2 adenomas were randomized into two groups: A) colonoscopy at 6 years and B) colonoscopy at 3 and 6 years.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Additional first or second-degree relatives with CRC
2. A personal history of inflammatory bowel disease
3. Previous colorectal surgery,
4. A first-degree relative with CRC with known microsatellite instability or strong suspicion of Lynch syndrome (e.g., combination of CRC and endometrial cancer).

Recruitment start date

01/01/2002

Recruitment end date

30/08/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center
Leiden
2300 RC
Netherlands

Trial participating centre

St. Antonius Hospital
Nieuwegein
3430 EM
Netherlands

Trial participating centre

Diaconessenhuis
Leiden
2300 RD
Netherlands

Trial participating centre

Martini Hospital
Groningen
9700 RM
Netherlands

Trial participating centre

University Medical Center Groningen
Groningen
9700 RB
Netherlands

Trial participating centre

Isala Clinics
Zwolle
8000 GK
Netherlands

Trial participating centre

Radboud University Medical Center
Nijmegen
6500 HB
Netherlands

Trial participating centre

Amphia Hospital
Breda
4800 RL
Netherlands

Trial participating centre

Maxima Medical Center
Eindhoven
5600 PD
Netherlands

Trial participating centre

Catharina Hospital
Eindhoven
5602 ZA
Netherlands

Trial participating centre

Medical Center Alkmaar
Alkmaar
1800 AM
Netherlands

Trial participating centre

Reinier de Graaf Gasthuis
Delft
2600 GA
Netherlands

Trial participating centre

Scheper Hospital
Emmen
7800 RA
Netherlands

Sponsor information

Organisation

Leiden University Medical Center

Sponsor details

Albinusdreef 2
Leiden
2333 ZA
Netherlands

Sponsor type

Hospital/treatment centre

Website

https://www.lumc.nl/

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

We would like to publish our results on a short term in a journal in general medicine, or specifically in the field of gastroenterology. Also, our plan is to submit the abstract to conferences (gastroenterology, hereditary tumours in the gastrointestinal tract).

Intention to publish date

01/02/2015

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes