C18 C19 C20
Conditions
Interventions
Group 1: Patients diagnosed with colorectal cancer aged 18-49 years
Group 2: Comparators without colorectal cancer aged 18-49 years
Sponsors
Universitätsklinikum Schleswig-Holstein (UKSH), Campus Lübeck, Lübeck, Deutschland
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of colorectal cancer 2. At the time of initial diagnosis, you must be over 18 years of age but not older than 50 years 3. If included, one of the following categories: a. Active disease (initial diagnosis or recurrence) b. Disease-free aftercare
Exclusion criteria
Exclusion criteria: 1. Disease-free for colorectal cancer for more than 5 years 2. Familial Adenomatous Polyposis (FAP) 3. Hereditary Non-Polyposis Colorectal Cancer Syndromes (HNPPC, Lynch Syndrome) 4. Other tumor diseases in the past 3 years apart from adequately treated cervical carcinoma or basal cell carcinoma of the skin or squamous cell carcinoma of the skin 5. Life expectancy < 3 months 6. Not able to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Specific goals of the individual sub-projects of the OUTLIVE study | — |
Secondary
| Measure | Time frame |
|---|---|
| Prognosis/survival/patient-reported outcomes of patients aged 18-49 years with diagnosis of colorectal cancer up to 5 years after diagnosis. Secondary Endpoint Definition of endpoints specific to TP5: Secondary Endpoints: • Positive ctDNA test when diagnosed prior to initiating therapy • Positive ctDNA test in case of recurrence • Changes in concentration/mutant allele frequency (MAF) and composition of ctDNA over time • Specificity and sensitivity of the ctDNA biomarker • Comparison of ddPCR with NGS | — |
Countries
Germany
Contacts
Public ContactEva Dazert-Klebsattel
Universitätsklinikum Schleswig-Holstein (UKSH), Klinik für Hämatologie und Onkologie, Biomedizinische Forschung (BMF)
Outcome results
None listed