Status:
RECRUITING
Spatial RadiomIcs and TRanscriptomics to the DIscovery of the Cross-link Between Colon Cancer and ChrOnic Kidney Disease
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Colorectal Cancer (CRC)
Eligibility:
All Genders
18+ years
Brief Summary
The incidence of colorectal cancer (CRC) is higher in patients with chronic kidney disease (CKD) compared to general population. Causal factors have not been clarified so far, although some hypothesis...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Life expectancy greater than 3 months \*\*
- Histopathological diagnosis of colorectal cancer stage I or II according to the TNM (Tumor, Node, Metastasis) classification
- Patients with tumors classified as T1-T3, N0, M0 (stage I-II) eligible for surgery
- Ability to understand and sign the informed consent
- Clinically stable patients with no significant changes in renal function or disease management in the weeks prior to enrollment \*\*
- For the non-CKD group
- • Adequate liver, renal and bone marrow function (adequate levels of hemoglobin, platelets, creatinine and bilirubin)
- For the CKD group
- Confirmed diagnosis of chronic kidney disease according to the KDIGO (Kidney Disease: Improving Global Outcomes) guidelines defined by a duration of at least three months with structural or functional abnormalities of the kidneys
- BSA (Body Surface Area Area) eGFR≤60 ml/min/1.73 m2
Exclusion
- Recent episodes of acute renal failure
- Kidney transplant, autoimmune diseases; inflammatory bowel diseases; other than oncological or oncohematological diseases of CRC
- Recent therapies with steroids/immunosuppressants and cardiovascular events (within 3 months of enrollment)
- History of serious allergic reactions to iodinated contrast agents or gadolinium-based contrast agents
- Recent or planned invasive or surgical treatments that could interfere with the study (within 3 months of enrollment)
- Psychiatric disorders that could impair the patient's ability to follow study procedures or provide informed consent
- Other types of concomitant or previous tumors in the previous 5 years of enrollment
- Pregnant or breastfeeding women. Pregnancy status will be ascertained before enrollment by measuring Beta-hCG in urine (Pregnancy Test or urinary beta-HCG) or in blood (plasma beta-hCG).
Key Trial Info
Start Date :
November 5 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06886282
Start Date
November 5 2024
End Date
August 31 2026
Last Update
March 20 2025
Active Locations (1)
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1
Radiology Division
Naples, Italy