Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05726188
Status:
RECRUITING
Last Update Posted:
2023-07-21
First Post:
2023-02-01
Brief Title:
Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer
Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Organization:
Azienda Ospedaliera Universitaria Integrata Verona
Study Overview
Official Title:
Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer - CORE1 COlon Cancer REcurrence in Stage 1
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CORE1
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None