The prospective data collection initiative on on small bowel, colorectal and anal cancer - a prospective observational cohort study.

Phase 4

Recruiting

• Conditions: anal cancer; Colorectal Cancer; small bowel cancer; 10017990; 10017991

• Registration Number: NL-OMON54603
• Lead Sponsor: Dutch Colorectal Cancer Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 25000

Inclusion Criteria

Age of 18 years or older
Histological proof of colorectal, small bowel or anal cancer, or a strong
suspicion after imaging
Informed consent for longitudinal observational data collection

Exclusion Criteria

Mentally incompetent

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Clinical parameters: medical history, co-morbidity, medication use, basic<br /><br>physical examination, laboratory results, imaging results, pathology results,<br /><br>tumor characteristics, treatment, treatment outcomes, hospital stays,<br /><br>interventions and adverse events.<br /><br>2. Clinical endpoints: treatment effect, adenoma-free survival, disease-free<br /><br>survival, progression-free survival, overall survival and grade 3/4 (serious)<br /><br>adverse events.<br /><br>3. Patient reported outcomes: health related quality of life, work<br /><br>participation and work ability.<br /><br>4. Biobanking of blood and tumor tissue</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a</p><br>