An interventional study of Personalized screening invitation interval in Colorectal Cancer, sponsored by Esther Toes-Zoutendijk. Not yet recruiting at 1 site in Netherlands. Open to participants aged 56 Years to 71 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-21.
Sponsored by Esther Toes-Zoutendijk · Not applicable, Interventional, and Screening
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).
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:
To achieve these goals a randomized controlled trial, focus groups and microsimulation modelling will be conducted.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 20,000 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →This is the only study on the registry with Esther Toes-Zoutendijk as lead sponsor.
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Exclusion Criteria:
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.
Other: Personalized screening invitation interval
Participants receive a standard screening invitation interval (2 years).
Time to receive the next invitation for fecal immunochemical testing screening, will depend based on individuals risk determined by fecal Hemoglobin concentration
Detection rate of colorectal cancer and advanced adenomas
Number of colorectal cancers and advanced adenomas per screened individual
Time frame: 6 months after the last invitation
Acceptability
Number of individuals participating in personalized FIT screening
Time frame: 6 months after the last invitation
Plan to share: 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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