Tumor Deposits in Colorectal Cancers (TD)

June 27, 2023 updated by: Gennaro Galizia, University of Campania "Luigi Vanvitelli"

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

243

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

colorectal cancer patients with metastatic nodes undergoing radical surgery and adjuvant chemotherapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tumor Deposits
Colorectal cancers with and without tumor deposits, undergoing curative surgery and adjuvant chemotherapy
Procedure: Colorectal Resection
Radical resection of colorectal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 5 years
1 to 5 years overall survival
5 years
Disease-free Survival
Time Frame: 5 years
1 to 5 years disease-free survival
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Investigators

  • Principal Investigator: Gennaro Galizia, MD, University of Campania 'Luigi Vanvitelli'

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

June 20, 2023

First Submitted That Met QC Criteria

June 20, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vanvitelli Naples

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all data will be shared after publication

IPD Sharing Time Frame

one month after publication

IPD Sharing Access Criteria

email to gennaro.galizia@unicampania.it

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Extranodal Extension

Clinical Trials on Colorectal Resection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe