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Effect of Temperament, Anxiety and Depression on Immuninity in Colorectal Cancer Patients. Effetti Del Temperamento, Dell'Ansia e Della Depressione Sulla Sopravvivenza Globale e Sulla Risposta Immunitaria Del Paziente Affetto da Adenocarcinoma Colo-Rettale.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01433146
First Posted: September 13, 2011
Last Update Posted: June 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marco La Torre, University of Roma La Sapienza
  Purpose
Aim of the study is to evaluate if Temperament, Anxiety and Depression can affect Immunity and influence Survival in Colorectal Cancer Patients

Condition
Temperament Anxiety Depression Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Temperament, Anxiety and Depression on Immuninity in Colorectal Cancer Patients.

Resource links provided by NLM:


Further study details as provided by Marco La Torre, University of Roma La Sapienza:

Primary Outcome Measures:
  • Temperament in non-metastatic colorectal cancer patients [ Time Frame: 24 months ]
    Evaluation if Temperament can be considered as dependent or indipendent prognostic factor for survival in non-metastatic colorectal cancer patients


Biospecimen Retention:   Samples Without DNA
Blood samples for cell-mediated immunity evaluaion

Estimated Enrollment: 120
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Detailed Description:

120 prospective patients, with non-metastatic colorectal cancer, will be evaluated with questionnaires and auto-questionnaires in order to assess temperament, anxiety and depression. The immunity status will be assessed by a blood sample with the aim to evaluate cell-mediated immunity.

Survivall will be related to level of anxiety/temperament/depression and cell-mediated immunity.

Univariate and multivariate model analisys will be performed in order to evaluate if anxiety/temperament/depression and cell-mediated immunity can be considered as prognostic factors.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
Criteria

Inclusion Criteria:

diagnosis of non-metastatic colorectal cancer

Exclusion Criteria:

previous other primary malignancies immunodepression diagnosis of major deppression diagnosis of anxiety/depression syndrome

  Contacts and Locations
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): NCT01433146


Locations
Italy
"Sapienza" University of Rome
Rome, Italy, 00100
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Marco La Torre, MD "Sapienza" University of Rome
  More Information

Publications:
Responsible Party: Marco La Torre, Medical Doctor, PhD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01433146     History of Changes
Other Study ID Numbers: 65422-SU-CE
First Submitted: September 10, 2011
First Posted: September 13, 2011
Last Update Posted: June 6, 2012
Last Verified: June 2012

Keywords provided by Marco La Torre, University of Roma La Sapienza:
Temperament
Anxiety
Depression
Colorectal Cancer

Additional relevant MeSH terms:
Depression
Depressive Disorder
Colorectal Neoplasms
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases