Identifying factors that predict recurrence after surgery for early-stage colon cancer
Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer - CORE1 (COlon Cancer REcurrence in Stage 1)
This study is trying to find out what factors might predict if early-stage colon cancer will come back after surgery, to help doctors better manage follow-up care for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 24 sites (Paris and 23 other locations) |
| Trial ID | NCT05726188 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with stage I colon cancer who have undergone curative surgery. It aims to assess the actual incidence of disease recurrence and identify clinical and pathological factors that may predict worse outcomes beyond standard staging. By analyzing data from multiple centers, the study seeks to improve prognostic stratification for this patient population, which currently has limited follow-up guidelines despite a small percentage experiencing recurrence. The findings could help refine follow-up protocols and patient management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have undergone curative resection for stage I colon cancer.
Not a fit: Patients with rectal cancer or those who have received neo-adjuvant chemotherapy or radiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict recurrence in stage I colon cancer patients, leading to improved monitoring and treatment strategies.
How similar studies have performed: While some studies have explored recurrence in later stages of colon cancer, this specific focus on stage I is less common and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris and 23 other locations
- Unit of Digestive and HPB Surgery, Henri Mordor University Hospital — Paris, France (Recruiting)
- Chirurgia dell'Apparato Digerente, IRCSS Giovanni Paolo II — Bari, Italy (Recruiting)
- Chirurgia Generale e Trapianto di Fegato, Azienda Ospedaliera Consorziale Policlinico di Bari — Bari, Italy (Recruiting)
- UO Chirurgia Generale 3, Spedali Civili 1 — Brescia, Italy (Recruiting)
- Chirurgia Coloproctologica, AOU Cagliari — Cagliari, Italy (Recruiting)
- Chirurgia Generale, Ospedale di Cles — Cles, Italy (Recruiting)
- Chirurgia 1, Ospedale di Cona, AOUI Ferrara — Cona, Italy (Recruiting)
- Chirurgia Generale Colorettale, Ospedale degli Infermi — Faenza, Italy (Recruiting)
- UOS Chirurgia Colo-rettale, Ospedale San Gerardo — Monza, Italy (Recruiting)
- Chirurgia Endoscopica, AOUI Federico II — Napoli, Italy (Recruiting)
- UOC Oncologia Chirurgia Colorettale, Istituto Nazionale Tumori - IRCCS Fondazione Pascale — Napoli, Italy (Recruiting)
- Chirurgia Generale, AOU San Luigi Gonzaga — Orbassano, Italy (Recruiting)
- Chirurgia Generale 3, AOUI Padova — Padova, Italy (Recruiting)
- ASL TO 3 Presidio Pinerolo, Chirurgia — Pinerolo, Italy (Recruiting)
- Chirurgia Generale 2, Policlinico Gemelli — Roma, Italy (Recruiting)
- Policlinico TOR Vergata, Roma, Chirurgia Mininvasiva e dell'Apparato Digerente — Roma, Italy (Recruiting)
- UOC Chirurgia Generale 1, Policlinico Gemelli — Roma, Italy (Recruiting)
- Chirurgia Generale, Ospedale Santa Maria della Misericordia — Rovigo, Italy (Recruiting)
- Chirurgia Colorettale, IRCCS Humanitas — Rozzano, Italy (Recruiting)
- Chirurgia d'Urgenza e PS 3, AOU Città della Salute e della Scienza — Torino, Italy (Recruiting)
- Chirurgia Generale e Mininvasiva, Ospedale San Camillo — Trento, Italy (Recruiting)
- SC Clinica Chirurgia, Azienda Sanitaria Universitaria Giuliano Isontina — Trieste, Italy (Recruiting)
- Unità di Chirurgia Colorettale, Clinica Santa Rita — Vercelli, Italy (Recruiting)
- Chirurgia Generale ed Epatobiliare, AOUI Verona — Verona, Italy (Recruiting)
Study contacts
- Study coordinator: Corrado Pedrazzani, MD
- Email: corrado.pedrazzani@univr.it
- Phone: +39 0458126719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.