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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05923450
Acronym
TD
Enrollment
243
Registered
2023-06-28
Start date
2012-01-01
Completion date
2023-03-31
Last updated
2023-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extranodal Extension

Keywords

tumor deposits, colorectal cancers, TNM staging system, ROC Curve

Brief 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.

Interventions

Radical resection of colorectal cancer

Sponsors

University of Campania Luigi Vanvitelli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* colorectal cancers in stage III TNM undergoing radical surgery and adjuvant chemotherapy

Exclusion criteria

* Lynch syndrome * Rectal Cancer undergoing neoadjuvant (radio)chemotherapy * colorectal cancers without metastatic nodes * metastatic colorectal cancers * eligible patients refusing adjuvant chemotherapy

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival5 years1 to 5 years overall survival
Disease-free Survival5 years1 to 5 years disease-free survival

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026