Clinical trial NCT05726188: Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer
Official title: Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer - CORE1 (COlon Cancer REcurrence in Stage 1)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colon Cancer Stage I
Colon Cancer
Keywords: prognosis
recurrence
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage I colon cancer who underwent curative surgery at the participating centers between January 2010 and December 2019.

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.


Eligibility 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

Primary outcomes:
measure: Recurrence
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Cancer-related survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Unit of Digestive and HPB Surgery, Henri Mordor University Hospital
city: Bari
country: Italy
facility: Chirurgia dell'Apparato Digerente, IRCSS Giovanni Paolo II
city: Bari
country: Italy
facility: Chirurgia Generale e Trapianto di Fegato, Azienda Ospedaliera Consorziale Policlinico di Bari
city: Brescia
country: Italy
facility: UO Chirurgia Generale 3, Spedali Civili 1
city: Cagliari
country: Italy
facility: Chirurgia Coloproctologica, AOU Cagliari
city: Cles
country: Italy
facility: Chirurgia Generale, Ospedale di Cles
city: Cona
country: Italy
facility: Chirurgia 1, Ospedale di Cona, AOUI Ferrara
city: Faenza
country: Italy
facility: Chirurgia Generale Colorettale, Ospedale degli Infermi
city: Monza
country: Italy
facility: UOS Chirurgia Colo-rettale, Ospedale San Gerardo
city: Napoli
country: Italy
facility: Chirurgia Endoscopica, AOUI Federico II
city: Napoli
country: Italy
facility: UOC Oncologia Chirurgia Colorettale, Istituto Nazionale Tumori - IRCCS Fondazione Pascale
city: Orbassano
country: Italy
facility: Chirurgia Generale, AOU San Luigi Gonzaga
city: Padova
country: Italy
facility: Chirurgia Generale 3, AOUI Padova
city: Pinerolo
country: Italy
facility: ASL TO 3 Presidio Pinerolo, Chirurgia
city: Roma
country: Italy
facility: Chirurgia Generale 2, Policlinico Gemelli
city: Roma
country: Italy
facility: Policlinico TOR Vergata, Roma, Chirurgia Mininvasiva e dell'Apparato Digerente
city: Roma
country: Italy
facility: UOC Chirurgia Generale 1, Policlinico Gemelli
city: Rovigo
country: Italy
facility: Chirurgia Generale, Ospedale Santa Maria della Misericordia
city: Rozzano
country: Italy
facility: Chirurgia Colorettale, IRCCS Humanitas
city: Torino
country: Italy
facility: Chirurgia d'Urgenza e PS 3, AOU Città della Salute e della Scienza
city: Trento
country: Italy
facility: Chirurgia Generale e Mininvasiva, Ospedale San Camillo
city: Trieste
country: Italy
facility: SC Clinica Chirurgia, Azienda Sanitaria Universitaria Giuliano Isontina
city: Vercelli
country: Italy
facility: Unità di Chirurgia Colorettale, Clinica Santa Rita
city: Verona
country: Italy
facility: Chirurgia Generale ed Epatobiliare, AOUI Verona
Study officials:
References: