Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer

NCT ID: NCT05726188

Last Updated: 2023-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Cancer Stage I Colon Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Colonic resection

Intervention Type PROCEDURE

Elective or urgent colonic resection; minimally-invasive or open surgery; completion surgery for endoscopically resected pT1 colon cancer with high risk features

Interventions

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Colonic resection

Elective or urgent colonic resection; minimally-invasive or open surgery; completion surgery for endoscopically resected pT1 colon cancer with high risk features

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Unit of Digestive and HPB Surgery, Henri Mordor University Hospital

Paris, , France

Site Status RECRUITING

Chirurgia dell'Apparato Digerente, IRCSS Giovanni Paolo II

Bari, , Italy

Site Status RECRUITING

Chirurgia Generale e Trapianto di Fegato, Azienda Ospedaliera Consorziale Policlinico di Bari

Bari, , Italy

Site Status RECRUITING

UO Chirurgia Generale 3, Spedali Civili 1

Brescia, , Italy

Site Status RECRUITING

Chirurgia Coloproctologica, AOU Cagliari

Cagliari, , Italy

Site Status RECRUITING

Chirurgia Generale, Ospedale di Cles

Cles, , Italy

Site Status RECRUITING

Chirurgia 1, Ospedale di Cona, AOUI Ferrara

Cona, , Italy

Site Status RECRUITING

Chirurgia Generale Colorettale, Ospedale degli Infermi

Faenza, , Italy

Site Status RECRUITING

UOS Chirurgia Colo-rettale, Ospedale San Gerardo

Monza, , Italy

Site Status RECRUITING

Chirurgia Endoscopica, AOUI Federico II

Napoli, , Italy

Site Status RECRUITING

UOC Oncologia Chirurgia Colorettale, Istituto Nazionale Tumori - IRCCS Fondazione Pascale

Napoli, , Italy

Site Status RECRUITING

Chirurgia Generale, AOU San Luigi Gonzaga

Orbassano, , Italy

Site Status RECRUITING

Chirurgia Generale 3, AOUI Padova

Padua, , Italy

Site Status RECRUITING

ASL TO 3 Presidio Pinerolo, Chirurgia

Pinerolo, , Italy

Site Status RECRUITING

Chirurgia Generale 2, Policlinico Gemelli

Roma, , Italy

Site Status RECRUITING

Policlinico TOR Vergata, Roma, Chirurgia Mininvasiva e dell'Apparato Digerente

Roma, , Italy

Site Status RECRUITING

UOC Chirurgia Generale 1, Policlinico Gemelli

Roma, , Italy

Site Status RECRUITING

Chirurgia Generale, Ospedale Santa Maria della Misericordia

Rovigo, , Italy

Site Status RECRUITING

Chirurgia Colorettale, IRCCS Humanitas

Rozzano, , Italy

Site Status RECRUITING

Chirurgia d'Urgenza e PS 3, AOU Città della Salute e della Scienza

Torino, , Italy

Site Status RECRUITING

Chirurgia Generale e Mininvasiva, Ospedale San Camillo

Trento, , Italy

Site Status RECRUITING

SC Clinica Chirurgia, Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, , Italy

Site Status RECRUITING

Unità di Chirurgia Colorettale, Clinica Santa Rita

Vercelli, , Italy

Site Status RECRUITING

Chirurgia Generale ed Epatobiliare, AOUI Verona

Verona, , Italy

Site Status RECRUITING

Countries

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France Italy

Central Contacts

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Corrado Pedrazzani, MD

Role: CONTACT

+39 0458126719

Elisa Corrado

Role: CONTACT

+39 045 8127038

Facility Contacts

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Nicola De Angelis

Role: primary

Michele Simone

Role: primary

Donato Francesco Altomare

Role: primary

Riccardo Nascimbeni

Role: primary

Luigi Zorcolo

Role: primary

Ciarleglio Francesco

Role: primary

Gabriele Anania

Role: primary

Isacco Montroni

Role: primary

Marco Braga

Role: primary

Marco Milone

Role: primary

Delrio Paolo

Role: primary

Maurizio Degiuli

Role: primary

Salvatore Pucciarelli

Role: primary

Andrea Muratore

Role: primary

Claudio Coco

Role: primary

Giuseppe Sica

Role: primary

Roberto Persiani

Role: primary

Maurizio De Luca

Role: primary

Antonino Spinelli

Role: primary

Mauro Santarelli

Role: primary

Alberto Di Leo

Role: primary

Nicolò de Manzini

Role: primary

Mario Trompetto

Role: primary

Corrado Pedrazzani

Role: primary

Other Identifiers

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CORE1

Identifier Type: -

Identifier Source: org_study_id

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