NCT05923450

Tumor Deposits in Colorectal Cancers

Presence of Tumor Deposits is a Strong Indicator of Poor Outcome in Stage III Colorectal Cancers Undergoing Radical Surgery: Need for an Urgent Revision of the Staging System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 243 (actual)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Tumor deposits (TDs) are emerging as an adverse prognostic factor in colorectal cancers (CRCs), but they are quite ignored in the current staging system. Previous proposals to incorporate TDs in node stage or consider them distant metastases raised some doubt. The Authors propose a new staging system to optimize treatments.

Detailed description

Tumor deposits (TDs) are emerging as an adverse prognostic factor in colorectal cancers (CRCs).In the current staging system TDs are somewhat neglected. It has been proposed to add TD count to the number of metastatic lymph nodes or to consider TDs as distant metastases, but the scientific basis of these proposals seems dubious and not supported by robust statistical analyses. The investigators supposed that splitting the three sub-stages of the stage III CRC according to absence or presence of TDs could be an easy and useful method to avoid the loss of crucial information. The proposed study will include 243 stage III CRC patients undergoing radical surgery and adjuvant chemotherapy. Each new substage, according to absence or presence of tumor deposits, will be analyzed with sophisticated statistical analysis (particularly the area-under-curve (AUC), calculated by the time-dependent receiver-operating-characteristic (ROC) curve for censored survival data) to individuate if this new staging does better the current one.

Conditions

• Extranodal Extension

Interventions

Type	Name	Description
PROCEDURE	Colorectal Resection	Radical resection of colorectal cancer

Timeline

• Start date: 2012-01-01
• Primary completion: 2022-12-31
• Completion: 2023-03-31
• First posted: 2023-06-28
• Last updated: 2023-06-29