Clinical trial · Observational
ALFAOMEGA Master Observational Trial
A Master Protocol Empowering Precision Research in Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
AlfaOmega has been designed to streamline the study of the co-evolutionary landscape between tumor and host cells in a cohort of CRC patients, with the aim of understanding how their outcomes can be significantly improved (e.g. reduction of their chance of recurrence and survival improval). This clinical resource for integrative clinical data and sample collection will allow the molecular story-telling of CRC metastatic spread along time and space and the selection of appropriate patients for experimentally-driven trials.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cohort of CRC patients
- description
- Stage-mixed cohort of at least 3000 patients through their course of treatments, until death or a minimum of 5 years.
- interventionNames
- Other: Observation
Primary outcomes (1)
- measure
- Number of patients longitudinally monitored
- timeFrame
- 6 months
- description
- 1. \- Number of recruited CRC cases in TIER1 with complete FFPE/clinical data match. 2. \- Number of recruited CRC cases in TIER2.
Secondary outcomes (1)
- measure
- Number of patients triaged in proof-of-concept (POC) clinical trials
- timeFrame
- 6 months
- description
- Number of CRC cases recruited in TIER3.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. TIER1 written Informed consent. 2. Patients ≥18 years of age. 3. Previous diagnosis of colorectal cancer, or a strong suspicion of CRC based on clinical and radiological findings. 4. In patients with previous diagnosis of CRC availability of diagnostic Formalin-Fixed, Paraffin Embedded (FFPE) blocks (surgical resection and/or tumor biopsies), or at least 10 slides (preferably 20). FFPE tissue blocks are always preferred to slides. 5. ECOG Performance status \< 2. Exclusion Criteria: 1. Any other current malignancy or malignancy diagnosed or relapsed within the past 5 years (other than non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer) 2. Patient unable to comply with the study protocol owing to psychological, social or geographical reasons. 3. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection.
References
Publications (0)
Data not yet available