Trial Title:
Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer
NCT ID:
NCT05726188
Condition:
Colon Cancer Stage I
Colon Cancer
Conditions: Official terms:
Colonic Neoplasms
Recurrence
Conditions: Keywords:
prognosis
recurrence
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
Colonic resection
Description:
Elective or urgent colonic resection; minimally-invasive or open surgery; completion
surgery for endoscopically resected pT1 colon cancer with high risk features
Arm group label:
Stage I colon cancer
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.
Criteria for eligibility:
Study pop:
Patients with stage I colon cancer who underwent curative surgery at the participating
centers between January 2010 and December 2019.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Unit of Digestive and HPB Surgery, Henri Mordor University Hospital
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Nicola De Angelis
Facility:
Name:
Chirurgia dell'Apparato Digerente, IRCSS Giovanni Paolo II
Address:
City:
Bari
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Michele Simone
Facility:
Name:
Chirurgia Generale e Trapianto di Fegato, Azienda Ospedaliera Consorziale Policlinico di Bari
Address:
City:
Bari
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Donato Francesco Altomare
Facility:
Name:
UO Chirurgia Generale 3, Spedali Civili 1
Address:
City:
Brescia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Riccardo Nascimbeni
Facility:
Name:
Chirurgia Coloproctologica, AOU Cagliari
Address:
City:
Cagliari
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Luigi Zorcolo
Facility:
Name:
Chirurgia Generale, Ospedale di Cles
Address:
City:
Cles
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Ciarleglio Francesco
Facility:
Name:
Chirurgia 1, Ospedale di Cona, AOUI Ferrara
Address:
City:
Cona
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Gabriele Anania
Facility:
Name:
Chirurgia Generale Colorettale, Ospedale degli Infermi
Address:
City:
Faenza
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Isacco Montroni
Facility:
Name:
UOS Chirurgia Colo-rettale, Ospedale San Gerardo
Address:
City:
Monza
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Marco Braga
Facility:
Name:
Chirurgia Endoscopica, AOUI Federico II
Address:
City:
Napoli
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Marco Milone
Facility:
Name:
UOC Oncologia Chirurgia Colorettale, Istituto Nazionale Tumori - IRCCS Fondazione Pascale
Address:
City:
Napoli
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Delrio Paolo
Facility:
Name:
Chirurgia Generale, AOU San Luigi Gonzaga
Address:
City:
Orbassano
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Maurizio Degiuli
Facility:
Name:
Chirurgia Generale 3, AOUI Padova
Address:
City:
Padova
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Salvatore Pucciarelli
Facility:
Name:
ASL TO 3 Presidio Pinerolo, Chirurgia
Address:
City:
Pinerolo
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Andrea Muratore
Facility:
Name:
Chirurgia Generale 2, Policlinico Gemelli
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Claudio Coco
Facility:
Name:
Policlinico TOR Vergata, Roma, Chirurgia Mininvasiva e dell'Apparato Digerente
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giuseppe Sica
Email:
sica.researchteam@gmail.com
Facility:
Name:
UOC Chirurgia Generale 1, Policlinico Gemelli
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Roberto Persiani
Facility:
Name:
Chirurgia Generale, Ospedale Santa Maria della Misericordia
Address:
City:
Rovigo
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Maurizio De Luca
Facility:
Name:
Chirurgia Colorettale, IRCCS Humanitas
Address:
City:
Rozzano
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Antonino Spinelli
Facility:
Name:
Chirurgia d'Urgenza e PS 3, AOU Città della Salute e della Scienza
Address:
City:
Torino
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Mauro Santarelli
Facility:
Name:
Chirurgia Generale e Mininvasiva, Ospedale San Camillo
Address:
City:
Trento
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alberto Di Leo
Facility:
Name:
SC Clinica Chirurgia, Azienda Sanitaria Universitaria Giuliano Isontina
Address:
City:
Trieste
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Nicolò de Manzini
Facility:
Name:
Unità di Chirurgia Colorettale, Clinica Santa Rita
Address:
City:
Vercelli
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Mario Trompetto
Facility:
Name:
Chirurgia Generale ed Epatobiliare, AOUI Verona
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Corrado Pedrazzani
Email:
corrado.pedrazzani@univr.it
Start date:
April 1, 2022
Completion date:
September 30, 2023
Lead sponsor:
Agency:
Azienda Ospedaliera Universitaria Integrata Verona
Agency class:
Other
Source:
Azienda Ospedaliera Universitaria Integrata Verona
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05726188
