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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.
Information provided by (Responsible Party):
Marco La Torre, University of Roma La Sapienza Identifier:
First received: September 10, 2011
Last updated: June 4, 2012
Last verified: June 2012

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

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 University of Roma La Sapienza:

Primary Outcome Measures:
  • Temperament in non-metastatic colorectal cancer patients [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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.


Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic


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
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Please refer to this study by its identifier: NCT01433146

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

Responsible Party: Marco La Torre, Medical Doctor, PhD, University of Roma La Sapienza Identifier: NCT01433146     History of Changes
Other Study ID Numbers: 65422-SU-CE
Study First Received: September 10, 2011
Last Updated: June 4, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
Colorectal Cancer

Additional relevant MeSH terms:
Anxiety Disorders
Colorectal Neoplasms
Depressive Disorder
Behavioral Symptoms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Mental Disorders
Mood Disorders
Neoplasms by Site
Rectal Diseases processed this record on February 25, 2015