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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.

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ClinicalTrials.gov Identifier: NCT01433146
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : June 6, 2012
Sponsor:
Information provided by (Responsible Party):
Marco La Torre, University of Roma La Sapienza

Brief Summary:
Aim of the study is to evaluate if Temperament, Anxiety and Depression can affect Immunity and influence Survival in Colorectal Cancer Patients

Condition or disease
Temperament Anxiety Depression Colorectal Cancer

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.


Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Temperament, Anxiety and Depression on Immuninity in Colorectal Cancer Patients.
Study Start Date : September 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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


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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


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

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 Posted: September 13, 2011    Key Record Dates
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