An observational study in Extranodal Extension, sponsored by University of Campania Luigi Vanvitelli. Completed. Per ClinicalTrials.gov, last updated 2023-06-29.
Sponsored by University of Campania Luigi Vanvitelli · Observational
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 243 is close to the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University of Campania Luigi Vanvitelli is the lead sponsor of 170 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
colorectal cancer patients with metastatic nodes undergoing radical surgery and adjuvant chemotherapy
Exclusion Criteria:
Colorectal cancers with and without tumor deposits, undergoing curative surgery and adjuvant chemotherapy
Procedure: Colorectal Resection
Radical resection of colorectal cancer
Overall Survival
1 to 5 years overall survival
Time frame: 5 years
Disease-free Survival
1 to 5 years disease-free survival
Time frame: 5 years
No study locations are listed for this record.
Plan to share: Yes — all data will be shared after publication
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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University of Campania Luigi Vanvitelli