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Factors Related to Adverse Events in Colorectal Cancer (CARESS-CCR)

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ClinicalTrials.gov Identifier: NCT02488161
Recruitment Status : Completed
First Posted : July 2, 2015
Last Update Posted : August 24, 2016
Sponsor:
Collaborators:
Fondo de Investigacion Sanitaria
Departamento de Sanidad del Gobierno Vasco (País Vasco, Spain)
Information provided by (Responsible Party):
JOSE M QUINTANA-LOPEZ, MD PhD, Hospital Galdakao-Usansolo

Brief Summary:
Coordinated multi-center project with several complementary goals in each one of the sub-projects included. Objectives: 1.To determine risk factors of death, or major complications in the short term; 2.To determine risk factors of death, tumor recurrence, major complications, readmission or deterioration of quality of life in the mid term; 3.Evaluation of patient reported outcomes from before the intervention to the end of the follow-up. 4.To study the role of immunohisto-chemistry markers in the prediction of similar adverse results. This sub-project (coordinator) will approach the determination of risk factors of death, tumor recurrence, major complications, readmission and deterioration of quality of medium term life (1-2 years). Methodology. Design: prospective cohort study with 2 years follow-up after the surgical intervention. Participant centers: 18 hospitals of 6 Autonomous Communities of all Spain. Patients diagnosed of colorectal cancer surgically intervened. Variables: pre-intervention, those of the hospital admission, sociodemographic, immunohisto-chemistry and clinical parameters, that could be in relation to the outcomes to study. Statistic analysis: a derivation sample will be created where the possible predicting parameters will be identified, by cancer of colon or rectum. Predictive models will be created with a good discriminative capacity. A validation of those models will be performed in a validation sub-sample. Logistic and Cox regression models will be used. Simulation models for the prediction of discreet events in the long term will be used.

Condition or disease Intervention/treatment
Colorectal Cancer Other: No intervention

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 2600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors of Adverse Outcomes at Short and Medium Term, and Development of Predictive Models, in Patients With Colorectal Cancer. IRYSS-coordinated Multicenter Study
Study Start Date : June 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with colorectal cancer
One cohort of patients with colorectal cancer, studied before the intervention, and one month, one year, two years, three years and five years after.
Other: No intervention



Primary Outcome Measures :
  1. Mortality [ Time Frame: up to five years ]

Secondary Outcome Measures :
  1. Number of participants with Readmission [ Time Frame: up to five years ]
  2. Number of participants with Reintervention [ Time Frame: up to five years ]
  3. Changes in health-related quality of life (in the questionnaires employed in the study) [ Time Frame: up to five years ]
  4. Number of participants with Complications [ Time Frame: up to five years ]
  5. Number of participants with Cancer recurrence [ Time Frame: up to five years ]

Biospecimen Retention:   None Retained
Fragments of colon or rectum obtained in the surgical intervention


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This prospective cohort study included patients drawn from 22 hospitals belonging to the Spanish National Health Service (SNS), which covers the majority (99.8%) of the population of Spain. All covered residents have free access to their primary care physician and to the ED of the hospitals. All of the hospitals have similar technological and human resources.

Patients with a diagnosis of colon or rectum cancer attending the surgical services of any of these hospitals to undergo surgery between June 2010 and December 2012 were informed of the goals of the study and invited to voluntarily participate.

Criteria

Inclusion Criteria:

  • Patients were eligible for the study if they were included in the surgical waiting list of one of the participating hospitals with a diagnosis of surgically resectable colon or rectum cancer. Colon or rectum cancer diagnosis was based on anatomopathological diagnosis after a biopsy by colonoscopy. Inclusion criteria were having diagnosed with colon cancer (up to 15 cm above the anal margin) and rectum (between the anal margin and 15 cm above it), where curative and / or palliative surgery for treatment by first time were applied and who sign the informed consent to participate in the study consent.

Exclusion Criteria:

  • Exclusion criteria were colon or rectum in situ cancer, unresectable tumor, severe mental or physical conditions which preclude the patient to respond to questionnaires, terminal patients, patients unable to respond to questionnaires from any cause or who do not give their consent to participate in the study.

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): NCT02488161


Sponsors and Collaborators
Hospital Galdakao-Usansolo
Fondo de Investigacion Sanitaria
Departamento de Sanidad del Gobierno Vasco (País Vasco, Spain)
Investigators
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Principal Investigator: Jose M Quintana, PhD Hospital Galdakao-Usansolo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: JOSE M QUINTANA-LOPEZ, MD PhD, PhD, Hospital Galdakao-Usansolo
ClinicalTrials.gov Identifier: NCT02488161     History of Changes
Other Study ID Numbers: PS09/00314
PS09/00910 ( Other Grant/Funding Number: Fondo de Investigación Sanitaria (Madrid, Spain) )
PS09/00746 ( Other Grant/Funding Number: Fondo de Investigación Sanitaria (Madrid, Spain) )
PS09/00805 ( Other Grant/Funding Number: Fondo de Investigación Sanitaria (Madrid, Spain) )
PI09/90460 ( Other Grant/Funding Number: Fondo de Investigación Sanitaria (Madrid, Spain) )
PI09/90490 ( Other Grant/Funding Number: Fondo de Investigación Sanitaria (Madrid, Spain) )
PI09/90453 ( Other Grant/Funding Number: Fondo de Investigación Sanitaria (Madrid, Spain) )
PI09/90441 ( Other Grant/Funding Number: Fondo de Investigación Sanitaria (Madrid, Spain) )
PI09/90397 ( Other Grant/Funding Number: Fondo de Investigación Sanitaria (Madrid, Spain) )
2010111098 ( Other Grant/Funding Number: Departamento de Sanidad del Gobierno Vasco (País Vasco, Spain) )
PI13/01692 ( Other Grant/Funding Number: Fondo de Investigación Sanitaria (Madrid, Spain) )
PI13/00013 ( Other Grant/Funding Number: Fondo de Investigación Sanitaria (Madrid, Spain) )
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Keywords provided by JOSE M QUINTANA-LOPEZ, MD PhD, Hospital Galdakao-Usansolo:
Colorectal cancer
Risk factors
Adverse events
Predictive models
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases