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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01433146
Other study ID # 65422-SU-CE
Secondary ID
Status Completed
Phase N/A
First received September 10, 2011
Last updated June 4, 2012
Start date September 2011
Est. completion date June 2012

Study information

Verified date June 2012
Source University of Roma La Sapienza
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date June 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria:

diagnosis of non-metastatic colorectal cancer

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Italy "Sapienza" University of Rome Rome

Sponsors (1)

Lead Sponsor Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Kohno Y, Maruyama M, Matsuoka Y, Matsushita T, Koeda M, Matsushima E. Relationship of psychological characteristics and self-efficacy in gastrointestinal cancer survivors. Psychooncology. 2010 Jan;19(1):71-6. doi: 10.1002/pon.1531. — View Citation

Nan KJ, Wei YC, Zhou FL, Li CL, Sui CG, Hui LY, Gao CG. Effects of depression on parameters of cell-mediated immunity in patients with digestive tract cancers. World J Gastroenterol. 2004 Jan 15;10(2):268-72. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Temperament in non-metastatic colorectal cancer patients Evaluation if Temperament can be considered as dependent or indipendent prognostic factor for survival in non-metastatic colorectal cancer patients 24 months Yes
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