Colorectal CancerPERFECT-FITNCT05423886
The Effectiveness of Personalized Colorectal Cancer Screening Based on Fecal Hemoglobin Concentration
A study testing Personalized screening invitation interval in people with Colorectal Cancer, run by Esther Toes-Zoutendijk at 1 site in Netherlands.
Trial summary
We aim to improve the yield and effectiveness of the Dutch colorectal cancer screening program by using a personalized screening strategy based on fecal Hemoglobin concentration in previous screening round for participants with a negative fecal immunochemical test (FIT). Read more about this study
- Who is it for?
- Ages 56 to 71 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Personalized screening invitation interval
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2022to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 56 to 71 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Previous negative FIT (below the cut-off of 47 microgram per gram feces)
Who cannot join
- Previously tested with FIT cut-off of 15 microgram per gram feces
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
ErasmusMC
Rotterdam, 3015 GD
Esther Toes-Zoutendijk, PhD, +31629535367, e.toes-zoutendijk@erasmusmc.nl
Lucie de Jonge, MSc, +31107038591, l.dejonge.3@erasmusmc.nl
About this study
We aim to improve the yield and effectiveness of the Dutch colorectal cancer screening program by using a personalized screening strategy based on fecal Hemoglobin concentration in previous screening round for participants with a negative fecal immunochemical test (FIT).
Read the detailed description
A fecal Hemoglobin concentration just below the cut-off of the fecal immunochemical test (FIT) is associated with a higher risk for the detection of colorectal cancer of advanced adenomas at consecutive screenings. Individuals with these higher fecal Hemoglobin concentrations may benefit from shorter screenings interval, whereas individuals without any fecal Hemoglobin concentrations could benefit from longer screening intervals.
A randomized controlled trial will be conducted within the national CRC screening program among individuals with a negative FIT in the previous screening round. Individuals in the intervention arm will receive an invitation after 1, 2, or 3 years depending on their fecal Hemoglobin concentration in the previous round, whereas individuals in the control arm will receive an invitation after 2 years according to current practice.
The overall aim of this study is to improve the balance between harms and benefits of CRC screening, by using a personalized approach based on fecal Hemoglobin concentration at previous screening. More specifically, this study has three goals:
- Evaluate the superiority of risk-based FIT screening in a randomized controlled study embedded in a running national screening program;
- Evaluate the feasibility and acceptability of risk-based FIT screening in a national screening program;
- Estimate the long-term effect of personalized screening versus uniform screening.
To achieve these goals a randomized controlled trial, focus groups and microsimulation modelling will be conducted.
- Conditions
- Colorectal Cancer
- Being tested
- Personalized screening invitation interval
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized screening invitation intervalOther
Time to receive the next invitation for fecal immunochemical testing screening, will depend based on individuals risk determined by fecal Hemoglobin concentration
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Participants receive a personalized screening invitation interval (1,2 or 3 years) based on their fecal Hemoglobin concentration of the negative fecal immunochemical test in previous round. Receives: Other: Personalized screening invitation interval |
| Control arm | No intervention | Participants receive a standard screening invitation interval (2 years). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of colorectal cancer and advanced adenomas
Number of colorectal cancers and advanced adenomas per screened individual
Measured: 6 months after the last invitation
Secondary outcomes (1)
Acceptability
Number of individuals participating in personalized FIT screening
Measured: 6 months after the last invitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study startSep 2022 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention arm receives their screening invitation within 1,2 or 3 years, depending on their previous fecal Hemoglobin concentration. The control arm receives their screening invitation in 2 years (current practice).
- Masking
- None (open label)
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esther Toes-Zoutendijk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esther Toes-Zoutendijk, Erasmus Medical Center
- Investigators
- Iris Lansdorp-Vogelaar, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423886
- Sponsor's protocol ID
- WO 19-44
- Acronym
- PERFECT-FIT
- Status last verified
- Jun 2022
- First submitted
- 14 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Outcomes of the study will be stored in the national screening information system, owned by a third-party sources. Data cannot be publicly shared.
Publications
Breekveldt ECH, Toes-Zoutendijk E, de Jonge L, Spaander MCW, Dekker E, van Kemenade FJ, van Vuuren AJ, Ramakers CRB, Nagtegaal ID, van Leerdam ME, Lansdorp-Vogelaar I. Personalized colorectal cancer screening: study protocol of a mixed-methods study on the effectiveness of tailored intervals based on prior f-Hb concentration in a fit-based colorectal cancer screening program (PERFECT-FIT). BMC Gastroenterol. 2023 Feb 22;23(1):45. doi: 10.1186/s12876-023-02670-1.
PubMed 36814185
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Personalized Colorectal Cancer Screening Based on Fecal Hemoglobin Concentration
- ClinicalTrials.gov ID
- NCT05423886
- Acronym / sponsor ID
- PERFECT-FIT / WO 19-44
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Esther Toes-ZoutendijkUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aim to improve the yield and effectiveness of the Dutch colorectal cancer screening program by using a personalized screening strategy based on fecal Hemoglobin concentration in previous screening round for participants with a negative fecal immunochemical test (FIT).
Detailed description
A fecal Hemoglobin concentration just below the cut-off of the fecal immunochemical test (FIT) is associated with a higher risk for the detection of colorectal cancer of advanced adenomas at consecutive screenings. Individuals with these higher fecal Hemoglobin concentrations may benefit from shorter screenings interval, whereas individuals without any fecal Hemoglobin concentrations could benefit from longer screening intervals.
A randomized controlled trial will be conducted within the national CRC screening program among individuals with a negative FIT in the previous screening round. Individuals in the intervention arm will receive an invitation after 1, 2, or 3 years depending on their fecal Hemoglobin concentration in the previous round, whereas individuals in the control arm will receive an invitation after 2 years according to current practice.
The overall aim of this study is to improve the balance between harms and benefits of CRC screening, by using a personalized approach based on fecal Hemoglobin concentration at previous screening. More specifically, this study has three goals:
- Evaluate the superiority of risk-based FIT screening in a randomized controlled study embedded in a running national screening program;
- Evaluate the feasibility and acceptability of risk-based FIT screening in a national screening program;
- Estimate the long-term effect of personalized screening versus uniform screening.
To achieve these goals a randomized controlled trial, focus groups and microsimulation modelling will be conducted.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention arm receives their screening invitation within 1,2 or 3 years, depending on their previous fecal Hemoglobin concentration. The control arm receives their screening invitation in 2 years (current practice).
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Personalized screening invitation intervalParticipants receive a personalized screening invitation interval (1,2 or 3 years) based on their fecal Hemoglobin concentration of the negative fecal immunochemical test in previous round. |
| Control arm | No intervention | –Participants receive a standard screening invitation interval (2 years). |
Who may qualify
- Ages
- 56 to 71 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Previous negative FIT (below the cut-off of 47 microgram per gram feces)
Key exclusion criteria (1 listed)
- Previously tested with FIT cut-off of 15 microgram per gram feces
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized screening invitation intervalTime to receive the next invitation for fecal immunochemical testing screening, will depend based on individuals risk determined by fecal Hemoglobin concentration | Other | Intervention arm |
Primary outcome
Detection rate of colorectal cancer and advanced adenomas
Time frame: 6 months after the last invitation
Number of colorectal cancers and advanced adenomas per screened individual
1 secondary outcome
Acceptability
Time frame: 6 months after the last invitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Derived from this study: PubMed 36814185Breekveldt ECH, Toes-Zoutendijk E, de Jonge L, Spaander MCW, Dekker E, van Kemenade FJ, van Vuuren AJ, Ramakers CRB, Nagtegaal ID, van Leerdam ME, Lansdorp-Vogelaar I. Personalized colorectal cancer screening: study protocol of a mixed-methods study on the effectiveness of tailored intervals based on prior f-Hb concentration in a fit-based colorectal cancer screening program (PERFECT-FIT). BMC Gastroenterol. 2023 Feb 22;23(1):45. doi: 10.1186/s12876-023-02670-1.
- Individual participant dataSharing planned: No. Outcomes of the study will be stored in the national screening information system, owned by a third-party sources. Data cannot be publicly shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iris Lansdorp-Vogelaar, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized screening invitation interval in people with Colorectal Cancer, run by Esther Toes-Zoutendijk at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esther Toes-Zoutendijk, PhD (+31107038454, e.toes-zoutendijk@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of colorectal cancer and advanced adenomas (time frame: 6 months after the last invitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05423886, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.