Colon Cancer Prevention - Innovative Strategies at the NCT

Not Applicable

• Conditions: Malignant neoplasm of colon; C18; C19; C20; Malignant neoplasm of rectosigmoid junction; Malignant neoplasm of rectum

• Registration Number: DRKS00018932
• Lead Sponsor: ationales Centrum für Tumorerkrankungen (NCT) und Deutsches Krebsforschungszentrum (DKFZ)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-31
• Study Completion: 2020-06-09
• Results First Posted: 2020-08-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 2787

Inclusion Criteria

Women or men
- Age 50 (>49) to 54 (<55) at the day of invitation to the study
- Main residence in Heidelberg, Mannheim and Rhine-Neckar-Kreis (as defined by community codes)
- Ability to speak and understand German language
- Ability to give legally binding informed consent

Exclusion Criteria

Participants, who have a history of colorectal cancer.
- have had a colonoscopy in the previous 5 years.
- have a history of FAP (Familial Adenomatous Polyposis) or Lynch Syndrome.
- are severely ill and not able to visit the IEZ

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study Part I:<br>Frequency of previous early detection examinations.<br>Collected at the end of the study as soon as all questionnaire data have been recorded, checked for plausibility and evaluated.<br><br>Study Part II:<br>Proportion of participants in whom colorectal neoplasms > 0.5 cm that are detected and removed at screening endoscopy.<br>Collected at the end of the study as soon as all endoscopy data have been recorded, checked for plausibility and evaluated.<br><br>Study Part III:<br>Sensitivity, specificity, positive and negative predictive values, area under the curve (AUC) of diagnostic tests for detection of CRC and colorectal adenomas.<br>Collected after the end of the study, as soon as bioprobes and associated medical data are included in biosamples analyses of different kinds (for example, metabolomics, proteomics, miRNA, SPS, Expression analysis, sequencing).

Secondary Outcome Measures

Name	Time	Method
tilization rate of any screening endoscopy. <br>Detection rate of any neoplasm. <br>Patient preference with respect to type of screening endoscopy (proportion). <br>Safety of the applied procedures, complication rates (established routine procedures, standard monitoring of complications).<br><br>Collected at the end of the study as soon as all endoscopy data has been recorded, checked for plausibility and evaluated.