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

Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer - CORE1 (COlon Cancer REcurrence in Stage 1)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05726188
Acronym
CORE1
Enrollment
2000
Registered
2023-02-13
Start date
2022-04-01
Completion date
2023-09-30
Last updated
2023-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer, Colon Cancer Stage I

Keywords

prognosis, recurrence

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.

Interventions

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

Sponsors

Azienda Ospedaliera Universitaria Integrata Verona
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence5 yearsNumber of patients who relapsed after curative resection

Secondary

MeasureTime frameDescription
Overall survival5 yearsPercentage of patients alive 5 years after surgery
Cancer-related survival5 yearsPercentage of patients who did not die from cancer-related causes

Countries

France, Italy

Contacts

Primary ContactCorrado Pedrazzani, MD
corrado.pedrazzani@univr.it+39 0458126719
Backup ContactElisa Corrado
supporto.noprofit@aovr.veneto.it+39 045 8127038

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026