Colorectal CancerNCT02665312
Cardiotoxicity and Risk Factors in Patients With Colorectal Cancer Receiving Fluoropyrimidine
An observational study of Colorectal Cancer, run by Fondazione del Piemonte per l'Oncologia at 8 sites in Italy.
Trial summary
observational prospective study, designed for patients with colorectal cancer receiving for the first time 5-FU or capecitabine, with or without other chemotherapy combinations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 200 participants
- Where
- 8 sitesItaly
- Study dates
- Jan 2016to Jan 2019
- 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 colorectal cancer receiving Oral or INfusional fluoropyrimidine Treatment
Who may be able to join
- Signed written informed consent
- Age ≥ 18 years
- Histologically confirmed adenocarcinoma of colon or rectum (any T, any N, any M) receiving for the first time 5-FU or capecitabine, with or without other chemotherapy combinations
Who cannot join
- Prior treatment with fluoropyrimidines
- Prior or concurrent chest radiotherapy
- Any prior or concurrent treatment with cardiotoxic drug
- Any serious or uncontrolled cardiovascular disease (defined by the specialist during cardiac examination, see section 6.3.2 for details )
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites, 8 recruiting
- Not yet recruiting
Ospedale San Lazzaro - ASL CN 2 Alba Bra
Alba, Cuneo, 12051
Mario Franchini, MD
- Recruiting
Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo
Candiolo, Turin, 10060
Celeste Cagnazzo, PhD, 00390119933851, celeste.cagnazzo@ircc.it
Francesco Leone, MD
- Not yet recruiting
AO Ordine Mauriziano di Torino
Turin, Turin, 101028
Elisa Sperti, MD
- Not yet recruiting
AOU Città della Salute e della Scienza di Torino - Presidio Molinette - Oncologia Medica 1
Turin, Turin, 10126
Patrizia Racca, MD
- Not yet recruiting
AOU Città della Salute e della Scienza di Torino - Presidio Molinette - Oncologia Medica 2
Turin, Turin, 10126
Mario Airoldi, MD
- Not yet recruiting
Ospedale Cottolengo
Turin, Turin, 10152
Alex Luca Gerbino, MD
- Not yet recruiting
Humanitas Gradenigo
Turin, Turin, 10153
Alessandro Comandone, MD
- Not yet recruiting
Ospedale San Giovanni Bosco - ASL TO2
Turin, Turin, 10154
Cristiano Oliva, MD
About this study
Official title: CHEmotherapy-induced Cardiotoxicity and Study of risK Factor Correlation in Patients With Colorectal Cancer Receiving Oral or INfusional Fluoropyrimidine Treatment - CHECKPOINT
observational prospective study, designed for patients with colorectal cancer receiving for the first time 5-FU or capecitabine, with or without other chemotherapy combinations.
Read the detailed description
All patients enrolled will be evaluated for cardiovascular risk factors and, if resulted at cardiovascular risk, they will be submitted to cardiac examination and therapy optimization before starting chemotherapy.
Patients will be evaluated with 12-lead ECG and blood sample for TnI and NT pro-BNP before start chemotherapy and on day 3 of chemotherapy during the first, second and third cycle.
All patients developing cardiovascular events will be submitted to blood sample for TnI, NT-proBNP, hsTnI and cardiac examination.
- Conditions
- Colorectal Cancer
- Keywords
- cardiotoxicity, fluoropyrimidine, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms, Cardiotoxicity
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the incidence of cardiovascular events during the first three cycles of therapy with capecitabine or 5-FU
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Leone, MD, Principal investigator, IRCCS Candiolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665312
- Sponsor's protocol ID
- CheckPoint
- Status last verified
- Sep 2016
- First submitted
- 23 Jan 2016
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHEmotherapy-induced Cardiotoxicity and Study of risK Factor Correlation in Patients With Colorectal Cancer Receiving Oral or INfusional Fluoropyrimidine Treatment - CHECKPOINT
- ClinicalTrials.gov ID
- NCT02665312
- Acronym / sponsor ID
- CheckPoint
- Conditions
- Colorectal Cancer
- Keywords
- cardiotoxicity, fluoropyrimidine, colorectal cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 27 Jan 2016 (estimated)
- 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.
observational prospective study, designed for patients with colorectal cancer receiving for the first time 5-FU or capecitabine, with or without other chemotherapy combinations.
Detailed description
All patients enrolled will be evaluated for cardiovascular risk factors and, if resulted at cardiovascular risk, they will be submitted to cardiac examination and therapy optimization before starting chemotherapy.
Patients will be evaluated with 12-lead ECG and blood sample for TnI and NT pro-BNP before start chemotherapy and on day 3 of chemotherapy during the first, second and third cycle.
All patients developing cardiovascular events will be submitted to blood sample for TnI, NT-proBNP, hsTnI and cardiac examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal cancer receiving Oral or INfusional fluoropyrimidine Treatment
Key inclusion criteria (3 listed)
- Signed written informed consent
- Age ≥ 18 years
- Histologically confirmed adenocarcinoma of colon or rectum (any T, any N, any M) receiving for the first time 5-FU or capecitabine, with or without other chemotherapy combinations
Key exclusion criteria (4 listed)
- Prior treatment with fluoropyrimidines
- Prior or concurrent chest radiotherapy
- Any prior or concurrent treatment with cardiotoxic drug
- Any serious or uncontrolled cardiovascular disease (defined by the specialist during cardiac examination, see section 6.3.2 for details )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the incidence of cardiovascular events during the first three cycles of therapy with capecitabine or 5-FU
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
Francesco Leone, MD principal investigator
IRCCS Candiolo
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Fondazione del Piemonte per l'Oncologia at 8 sites in Italy.
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 3 inclusion and 4 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. 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 Celeste Cagnazzo, PhD (00390119933851, celeste.cagnazzo@ircc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the incidence of cardiovascular events during the first three cycles of therapy with capecitabine or 5-FU (time frame: 24 months). 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 23 Sep 2016.