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Cardiotoxicity and Risk Factors in Patients With Colorectal Cancer Receiving Fluoropyrimidine

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ClinicalTrials.gov Identifier: NCT02665312
Recruitment Status : Recruiting
First Posted : January 27, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Fondazione del Piemonte per l'Oncologia

Brief 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.

Condition or disease
Colorectal Cancer

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 Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CHEmotherapy-induced Cardiotoxicity and Study of risK Factor Correlation in Patients With Colorectal Cancer Receiving Oral or INfusional Fluoropyrimidine Treatment - CHECKPOINT
Study Start Date : January 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Assessment of the incidence of cardiovascular events during the first three cycles of therapy with capecitabine or 5-FU [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with colorectal cancer receiving Oral or INfusional fluoropyrimidine Treatment
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665312


Contacts
Contact: Celeste Cagnazzo, PhD 00390119933851 celeste.cagnazzo@ircc.it

Locations
Italy
Ospedale San Lazzaro - ASL CN 2 Alba Bra Not yet recruiting
Alba, Cuneo, Italy, 12051
Contact: Mario Franchini, MD         
Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo Recruiting
Candiolo, Turin, Italy, 10060
Contact: Celeste Cagnazzo, PhD    00390119933851    celeste.cagnazzo@ircc.it   
Principal Investigator: Francesco Leone, MD         
Sub-Investigator: Alessandro Bonzano, MD         
Sub-Investigator: Ilaria Depetris, MD         
Sub-Investigator: Massimo Aglietta, MD         
AO Ordine Mauriziano di Torino Not yet recruiting
Turin, Italy, 101028
Contact: Elisa Sperti, MD         
AOU Città della Salute e della Scienza di Torino - Presidio Molinette - Oncologia Medica 1 Not yet recruiting
Turin, Italy, 10126
Contact: Patrizia Racca, MD         
AOU Città della Salute e della Scienza di Torino - Presidio Molinette - Oncologia Medica 2 Not yet recruiting
Turin, Italy, 10126
Contact: Mario Airoldi, MD         
Ospedale Cottolengo Not yet recruiting
Turin, Italy, 10152
Contact: Alex Luca Gerbino, MD         
Humanitas Gradenigo Not yet recruiting
Turin, Italy, 10153
Contact: Alessandro Comandone, MD         
Ospedale San Giovanni Bosco - ASL TO2 Not yet recruiting
Turin, Italy, 10154
Contact: Cristiano Oliva, MD         
Sponsors and Collaborators
Fondazione del Piemonte per l'Oncologia
Investigators
Principal Investigator: Francesco Leone, MD IRCCS Candiolo

Responsible Party: Fondazione del Piemonte per l'Oncologia
ClinicalTrials.gov Identifier: NCT02665312     History of Changes
Other Study ID Numbers: CheckPoint
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Fondazione del Piemonte per l'Oncologia:
cardiotoxicity
fluoropyrimidine
colorectal cancer

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Colorectal Neoplasms
Cardiotoxicity
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathologic Processes
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries