Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-01-05 @ 5:46 PM
Study NCT ID:
NCT05923450
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2023-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumor Deposits in Colorectal Cancers
Sponsor:
University of Campania Luigi Vanvitelli
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TD
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: