NCT05923450

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

11 years

First QC Date

June 20, 2023

Last Update Submit

June 27, 2023

Conditions

Extranodal Extension

Keywords

tumor depositscolorectal cancersTNM staging systemROC Curve

Outcome Measures

Primary Outcomes (2)

  • Overall Survival

    1 to 5 years overall survival

    5 years

  • Disease-free Survival

    1 to 5 years disease-free survival

    5 years

Study Arms (1)

Tumor Deposits

Colorectal cancers with and without tumor deposits, undergoing curative surgery and adjuvant chemotherapy

Procedure: Colorectal Resection

Interventions

Colorectal ResectionPROCEDURE

Radical resection of colorectal cancer

Tumor Deposits

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Galizia G, Lieto E, Auricchio A, Cardella F, Mabilia A, Podzemny V, Castellano P, Orditura M, Napolitano V. Naples Prognostic Score, Based on Nutritional and Inflammatory Status, is an Independent Predictor of Long-term Outcome in Patients Undergoing Surgery for Colorectal Cancer. Dis Colon Rectum. 2017 Dec;60(12):1273-1284. doi: 10.1097/DCR.0000000000000961.

    PMID: 29112563BACKGROUND

  • Cervantes A, Adam R, Rosello S, Arnold D, Normanno N, Taieb J, Seligmann J, De Baere T, Osterlund P, Yoshino T, Martinelli E; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Jan;34(1):10-32. doi: 10.1016/j.annonc.2022.10.003. Epub 2022 Oct 25. No abstract available.

    PMID: 36307056RESULT

  • Pyo DH, Kim SH, Ha SY, Yun SH, Cho YB, Huh JW, Park YA, Shin JK, Lee WY, Kim HC. Revised Nodal Staging Integrating Tumor Deposit Counts With Positive Lymph Nodes in Patients With Stage III Colon Cancer. Ann Surg. 2023 Apr 1;277(4):e825-e831. doi: 10.1097/SLA.0000000000005355. Epub 2021 Dec 23.

    PMID: 34954753RESULT

  • Khan H, Radomski SN, Siddiqi A, Zhou N, Paneitz DC, Johnston FM, Greer JB. Tumor deposits are associated with a higher risk of peritoneal disease in non-metastatic colorectal cancer patients. J Surg Oncol. 2023 May;127(6):975-982. doi: 10.1002/jso.27207. Epub 2023 Feb 15.

    PMID: 36790093RESULT

  • Lieto E, Auricchio A, Ronchi A, Del Sorbo G, Panarese I, Ferraraccio F, De Vita F, Galizia G, Cardella F. Presence of tumor deposits is a strong indicator of poor outcome in patients with stage III colorectal cancers undergoing radical surgery. J Gastrointest Surg. 2024 Jan;28(1):47-56. doi: 10.1016/j.gassur.2023.11.003.

    PMID: 38353074DERIVED

MeSH Terms

Conditions

Extranodal ExtensionColorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Gennaro Galizia, MD

    University of Campania 'Luigi Vanvitelli'

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Surgery

Study Record Dates

First Submitted

June 20, 2023

First Posted

June 28, 2023

Study Start

January 1, 2012

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

June 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

all data will be shared after publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
one month after publication
Access Criteria
email to gennaro.galizia@unicampania.it