Colon Cancer Stage ICORE1NCT05726188
Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer
An observational study of Colon Cancer Stage I and Colon Cancer, run by Azienda Ospedaliera Universitaria Integrata Verona at 24 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer Stage I, Colon Cancer
- What is being tested?
- Colonic resection
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 1 Apr 2022to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage I colon cancer who underwent curative surgery at the participating centers between January 2010 and December 2019.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
Italy23 sites, 23 recruiting
- Recruiting
Chirurgia dell'Apparato Digerente, IRCSS Giovanni Paolo II
Bari
Michele Simone
- Recruiting
Chirurgia Generale e Trapianto di Fegato, Azienda Ospedaliera Consorziale Policlinico di Bari
Bari
Donato Francesco Altomare
- Recruiting
UO Chirurgia Generale 3, Spedali Civili 1
Brescia
Riccardo Nascimbeni
- Recruiting
Chirurgia Coloproctologica, AOU Cagliari
Cagliari
Luigi Zorcolo
- Recruiting
Chirurgia Generale, Ospedale di Cles
Cles
Ciarleglio Francesco
- Recruiting
Chirurgia 1, Ospedale di Cona, AOUI Ferrara
Cona
Gabriele Anania
- Recruiting
Chirurgia Generale Colorettale, Ospedale degli Infermi
Faenza
Isacco Montroni
- Recruiting
UOS Chirurgia Colo-rettale, Ospedale San Gerardo
Monza
Marco Braga
- Recruiting
Chirurgia Endoscopica, AOUI Federico II
Naples
Marco Milone
- Recruiting
UOC Oncologia Chirurgia Colorettale, Istituto Nazionale Tumori - IRCCS Fondazione Pascale
Naples
Delrio Paolo
- Recruiting
Chirurgia Generale, AOU San Luigi Gonzaga
Orbassano
Maurizio Degiuli
- Recruiting
Chirurgia Generale 3, AOUI Padova
Padova
Salvatore Pucciarelli
- Recruiting
ASL TO 3 Presidio Pinerolo, Chirurgia
Pinerolo
Andrea Muratore
- Recruiting
Chirurgia Generale 2, Policlinico Gemelli
Roma
Claudio Coco
- Recruiting
Policlinico TOR Vergata, Roma, Chirurgia Mininvasiva e dell'Apparato Digerente
Roma
Giuseppe Sica, sica.researchteam@gmail.com
- Recruiting
UOC Chirurgia Generale 1, Policlinico Gemelli
Roma
Roberto Persiani
- Recruiting
Chirurgia Generale, Ospedale Santa Maria della Misericordia
Rovigo
Maurizio De Luca
- Recruiting
Chirurgia Colorettale, IRCCS Humanitas
Rozzano
Antonino Spinelli
- Recruiting
Chirurgia d'Urgenza e PS 3, AOU Città della Salute e della Scienza
Torino
Mauro Santarelli
- Recruiting
Chirurgia Generale e Mininvasiva, Ospedale San Camillo
Trento
Alberto Di Leo
- Recruiting
SC Clinica Chirurgia, Azienda Sanitaria Universitaria Giuliano Isontina
Trieste
Nicolò de Manzini
- Recruiting
Unità di Chirurgia Colorettale, Clinica Santa Rita
Vercelli
Mario Trompetto
- Recruiting
Chirurgia Generale ed Epatobiliare, AOUI Verona
Verona, 37134
Corrado Pedrazzani, corrado.pedrazzani@univr.it
France1 site, 1 recruiting
- Recruiting
Unit of Digestive and HPB Surgery, Henri Mordor University Hospital
Paris
Nicola De Angelis
About this study
Official title: Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer - CORE1 (COlon Cancer REcurrence in Stage 1)
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:
- Assess the actual incidence of recurrence in a large cohort of patients with stage I CC undergone curative resection.
- Investigate the clinical and pathological characteristics of patients who developed a recurrence, with the aim of identifying those associated with a significantly increased risk.
- Analyze the pattern of recurrence.
- Analyze survival after recurrence.
- Conditions
- Colon Cancer Stage I, Colon Cancer
- Being tested
- Colonic resection
- Keywords
- prognosis, recurrence
- Medical subject headings
- Colonic Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonic resectionProcedure or surgery
Elective or urgent colonic resection; minimally-invasive or open surgery; completion surgery for endoscopically resected pT1 colon cancer with high risk features
| Study group | Role | What they receive |
|---|---|---|
| Stage I colon cancer | Patients aged 18 years or above with pT1 or pT2 N0 colon cancer (up to the recto-sigmoid junction) who underwent curative resection between January 2010 and December 2019 Receives: Procedure: Colonic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Number of patients who relapsed after curative resection
Measured: 5 years
Secondary outcomes (2)
Overall survival
Percentage of patients alive 5 years after surgery
Measured: 5 years
Cancer-related survival
Percentage of patients who did not die from cancer-related causes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Apr 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer Stage IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726188
- Sponsor's protocol ID
- CORE1
- Acronym
- CORE1
- Status last verified
- Jul 2023
- First submitted
- 1 Feb 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer - CORE1 (COlon Cancer REcurrence in Stage 1)
- ClinicalTrials.gov ID
- NCT05726188
- Acronym / sponsor ID
- CORE1 / CORE1
- Conditions
- Colon Cancer Stage I, Colon Cancer
- Keywords
- prognosis, recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess the actual incidence of recurrence in a large cohort of patients with stage I CC undergone curative resection.
- Investigate the clinical and pathological characteristics of patients who developed a recurrence, with the aim of identifying those associated with a significantly increased risk.
- Analyze the pattern of recurrence.
- Analyze survival after recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage I colon cancer | – | Procedure: Colonic resectionPatients aged 18 years or above with pT1 or pT2 N0 colon cancer (up to the recto-sigmoid junction) who underwent curative resection between January 2010 and December 2019 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage I colon cancer who underwent curative surgery at the participating centers between January 2010 and December 2019.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonic resectionElective or urgent colonic resection; minimally-invasive or open surgery; completion surgery for endoscopically resected pT1 colon cancer with high risk features | Procedure or surgery | Stage I colon cancer |
Primary outcome
Recurrence
Time frame: 5 years
Number of patients who relapsed after curative resection
2 secondary outcomes
Overall survival
Time frame: 5 years
Cancer-related survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer Stage I and Colon Cancer, run by Azienda Ospedaliera Universitaria Integrata Verona at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Corrado Pedrazzani, MD (+39 0458126719, corrado.pedrazzani@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.