Trials / Unknown
UnknownNCT05726188
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,000 (estimated)
- Sponsor
- Azienda Ospedaliera Universitaria Integrata Verona · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Colonic resection | Elective or urgent colonic resection; minimally-invasive or open surgery; completion surgery for endoscopically resected pT1 colon cancer with high risk features |
Timeline
- Start date
- 2022-04-01
- Primary completion
- 2023-09-30
- Completion
- 2023-09-30
- First posted
- 2023-02-13
- Last updated
- 2023-07-21
Locations
24 sites across 2 countries: France, Italy
Source: ClinicalTrials.gov record NCT05726188. Inclusion in this directory is not an endorsement.