- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01433146
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.
Effect of Temperament, Anxiety and Depression on Immuninity in Colorectal Cancer Patients.
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Rome, Italy, 00100
- "Sapienza" University of Rome
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Temperament in non-metastatic colorectal cancer patients
Time Frame: 24 months
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Evaluation if Temperament can be considered as dependent or indipendent prognostic factor for survival in non-metastatic colorectal cancer patients
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24 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marco La Torre, MD, University of Roma La Sapienza
Publications and helpful links
General Publications
- 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. doi: 10.3748/wjg.v10.i2.268.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Digestive System Diseases
- Mood Disorders
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Depression
- Depressive Disorder
- Colorectal Neoplasms
- Anxiety Disorders
Other Study ID Numbers
- 65422-SU-CE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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