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Factors Related to Adverse Events in Colorectal Cancer

NCT02488161 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2600

Last updated 2016-08-24

No results posted yet for this study

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.

Conditions

Interventions

OTHER

No intervention

Sponsors & Collaborators

  • Fondo de Investigacion Sanitaria

    collaborator OTHER

  • Departamento de Sanidad del Gobierno Vasco (País Vasco, Spain)

    collaborator UNKNOWN

  • Hospital Galdakao-Usansolo

    lead OTHER_GOV

Principal Investigators

  • Jose M Quintana, PhD · Hospital Galdakao-Usansolo

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-12-31
Completion
2015-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02488161 on ClinicalTrials.gov