CClinicalTrials.gg
CompletedNCT01433146Updated Jun 6, 2012

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.

An observational study in Temperament, Anxiety and Depression, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-06-06.

Sponsored by University of Roma La Sapienza · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
30 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Temperament
  • Anxiety
  • Depression
  • Colorectal Cancer

Keywords

  • Temperament
  • Anxiety
  • Depression
  • Colorectal Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 120 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary care clinic

Inclusion criteria

diagnosis of non-metastatic colorectal cancer

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 months

07

Study locations

1 site
  • "Sapienza" University of Rome
    Rome, 00100, Italy
08

References and documents

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. PubMed 14716837 ↗
  • 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. PubMed 19204934 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01433146
Lead sponsor
University of Roma La Sapienza
Responsible party
Marco La Torre (Medical Doctor, PhD, University of Roma La Sapienza) — Principal investigator
First posted
Sep 13, 2011
Start date
Sep 2011
Primary completion
Jan 2012
Completion
Jun 2012
Last update
Jun 6, 2012

Study contacts

Marco La Torre, MD
principal investigator · University of Roma La Sapienza

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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