Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.

Launched by UNIVERSITY HOSPITAL, GHENT · Dec 13, 2018

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help doctors find the sentinel lymph node (SLN) during surgery for colon cancer. The SLN is the first lymph node that cancer cells are likely to spread to, so locating it can help determine how advanced the cancer is. Researchers are using a special imaging technique that makes the SLN glow, allowing for easier detection during minimally invasive surgeries. They are also studying how the immune system and surrounding tissues change in both healthy and cancer-invaded lymph nodes to better understand the disease.

To join this trial, participants should be adults aged 65 to 74 who have been diagnosed with a specific type of colon cancer called adenocarcinoma, which is at an early stage (stage II) and has not spread to other areas. They must be fit for surgery and able to understand the treatment process. Participants will undergo laparoscopic surgery, which is less invasive, and may experience the benefits of advanced imaging techniques. It's important to note that individuals with more advanced cancer or certain health issues may not be eligible. If you're interested and meet the criteria, your healthcare team can provide more details on what to expect.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Tumor type: proven adenocarcinoma of the colon
• • Extent of disease (AJCC 7th edition): clinically node negative (stage II) non-metastatic colon cancer
• • Locally resectable disease
• • Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent
• • Laboratory data
• • Serum creatinine ≤ 1.5 mg/dl or a calculated GFR ≥ 60 mL/min/1.73 m2
• • Serum total bilirubin ≤ 1.5 mg/dl, except for known Gilbert's disease
• • Platelet count \> 100,000/µl
• • Hemoglobin \> 9g/dl
• • Neutrophil granulocytes \> 1,500/ml
• • International Normalized Ratio (INR) ≤ 2
• • Absence of alcohol and/or drug abuse
• • No inclusion in other clinical trials interfering with the study protocol
• • No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy
• • Absence of any severe organ insufficiency
• • No pregnancy or breast feeding
• • Adequate contraception in fertile patients
• • Written informed consent
• Exclusion Criteria:
• • Node positive and/or metastatic disease
• • Locally unresectable disease
• • Medically unfit patients (Karnofsky index \< 70%)
• • Allergies to any of the procedural substances (allergy to iodides, hypersensitivity to products containing human albumin)