Exploring the link between colon cancer and chronic kidney disease

Spatial RadiomIcs and TRanscriptomics to the DIscovery of the Cross-link Between Colon Cancer and ChrOnic Kidney Disease

This study is trying to see how chronic kidney disease affects the growth of early-stage colon cancer in patients who are having surgery.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Cancer Institute, Naples (other)
• Locations: 1 site (Naples)
• Trial ID: NCT06886282 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between colorectal cancer (CRC) and chronic kidney disease (CKD) by characterizing the tumor microenvironment in patients undergoing surgery. It aims to compare two groups of CRC patients: those with stage I-II CRC alone and those with stage I-II CRC who also have CKD. The study will collect anthropological, clinical, and laboratory data to better understand the impact of CKD on cancer progression. The research is conducted across three prominent hospitals and a genetic research institute in Italy.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with stage I or II colorectal cancer, either with or without chronic kidney disease.

Not a fit: Patients with advanced colorectal cancer or those with recent acute renal failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the mechanisms linking CKD and CRC, potentially leading to improved treatment strategies for affected patients.

How similar studies have performed: While the specific approach of this study is novel, previous research has indicated a higher incidence of CRC in CKD patients, suggesting a need for further exploration in this area.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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).

Where this trial is running

Naples

• Radiology Division — Naples, Italy (RECRUITING)

Study contacts

• Study coordinator: Antonella Petrillo

Conditions: Colorectal Cancer