Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer
CORE1
1 other identifier
observational
2,000
2 countries
24
Brief Summary
Patients with stage I (pT1-2 N0 M0) colon cancer (CC) accounts for 15-20% of colonic neoplasia. Stage I CC is mostly cured with surgical resection, consequently, adjuvant chemotherapy is never considered for this subset of patients. Moreover, some international guidelines, including NCCN guidelines, recommend less intensive follow-up 1. However, around 5% of patients with stage I CC will develop a recurrence within 5 years from surgery. Despite the very good prognosis usually attributed to this stage (5-years relapse-free survival: 95%), some clinical and pathological factors beyond the standard AJCC staging may be associated with worse clinical features and may aid in prognostic stratification. Although some authors investigated the role of pathological and clinical factors in patients with stage II and III disease, only few data are available for patients with stage I CC1. The present multicentric retrospective study aims to:
- 1.Assess the actual incidence of recurrence in a large cohort of patients with stage I CC undergone curative resection.
- 2.Investigate the clinical and pathological characteristics of patients who developed a recurrence, with the aim of identifying those associated with a significantly increased risk.
- 3.Analyze the pattern of recurrence.
- 4.Analyze survival after recurrence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 1, 2023
CompletedFirst Posted
Study publicly available on registry
February 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedJuly 21, 2023
July 1, 2023
1.5 years
February 1, 2023
July 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence
Number of patients who relapsed after curative resection
5 years
Secondary Outcomes (2)
Overall survival
5 years
Cancer-related survival
5 years
Study Arms (1)
Stage I colon cancer
Patients aged 18 years or above with pT1 or pT2 N0 colon cancer (up to the recto-sigmoid junction) who underwent curative resection between January 2010 and December 2019
Interventions
Elective or urgent colonic resection; minimally-invasive or open surgery; completion surgery for endoscopically resected pT1 colon cancer with high risk features
Eligibility Criteria
Patients with stage I colon cancer who underwent curative surgery at the participating centers between January 2010 and December 2019.
You may qualify if:
- Age ≥ 18 years
- Colon cancer up to recto-sigmoid junction
- Histological diagnosis of adenocarcinoma
- pT1 or pT2 according to AJCC staging system
- Urgent and elective surgery
- Curative resection
- Minimally invasive or open surgery
- Completion surgery included (Surgery for endoscopically resected pT1)
You may not qualify if:
- Rectal cancer
- Adenoma with low- or high-grade dysplasia
- Histology other than adenocarcinoma (i.e., lymphoma, neuroendocrine tumor, squamous carcinoma, etc)
- Neo-adjuvant chemotherapy or radiotherapy
- History of tumors other than CC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unit of Digestive and HPB Surgery, Henri Mordor University Hospital
Paris, France
Chirurgia dell'Apparato Digerente, IRCSS Giovanni Paolo II
Bari, Italy
Chirurgia Generale e Trapianto di Fegato, Azienda Ospedaliera Consorziale Policlinico di Bari
Bari, Italy
UO Chirurgia Generale 3, Spedali Civili 1
Brescia, Italy
Chirurgia Coloproctologica, AOU Cagliari
Cagliari, Italy
Chirurgia Generale, Ospedale di Cles
Cles, Italy
Chirurgia 1, Ospedale di Cona, AOUI Ferrara
Cona, Italy
Chirurgia Generale Colorettale, Ospedale degli Infermi
Faenza, Italy
UOS Chirurgia Colo-rettale, Ospedale San Gerardo
Monza, Italy
Chirurgia Endoscopica, AOUI Federico II
Napoli, Italy
UOC Oncologia Chirurgia Colorettale, Istituto Nazionale Tumori - IRCCS Fondazione Pascale
Napoli, Italy
Chirurgia Generale, AOU San Luigi Gonzaga
Orbassano, Italy
Chirurgia Generale 3, AOUI Padova
Padua, Italy
ASL TO 3 Presidio Pinerolo, Chirurgia
Pinerolo, Italy
Chirurgia Generale 2, Policlinico Gemelli
Roma, Italy
Policlinico TOR Vergata, Roma, Chirurgia Mininvasiva e dell'Apparato Digerente
Roma, Italy
UOC Chirurgia Generale 1, Policlinico Gemelli
Roma, Italy
Chirurgia Generale, Ospedale Santa Maria della Misericordia
Rovigo, Italy
Chirurgia Colorettale, IRCCS Humanitas
Rozzano, Italy
Chirurgia d'Urgenza e PS 3, AOU Città della Salute e della Scienza
Torino, Italy
Chirurgia Generale e Mininvasiva, Ospedale San Camillo
Trento, Italy
SC Clinica Chirurgia, Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, Italy
Unità di Chirurgia Colorettale, Clinica Santa Rita
Vercelli, Italy
Chirurgia Generale ed Epatobiliare, AOUI Verona
Verona, 37134, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2023
First Posted
February 13, 2023
Study Start
April 1, 2022
Primary Completion
September 30, 2023
Study Completion
September 30, 2023
Last Updated
July 21, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share