NCT01433146

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 6, 2012

Status Verified

June 1, 2012

Enrollment Period

4 months

First QC Date

September 10, 2011

Last Update Submit

June 4, 2012

Conditions

TemperamentAnxietyDepressionColorectal Cancer

Keywords

TemperamentAnxietyDepressionColorectal Cancer

Outcome Measures

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

    24 months

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • diagnosis of non-metastatic colorectal cancer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Sapienza" University of Rome

Rome, Rome, 00100, Italy

Location

Related Publications (2)

  • 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.

    PMID: 14716837BACKGROUND

  • 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.

    PMID: 19204934BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for cell-mediated immunity evaluaion

MeSH Terms

Conditions

Anxiety DisordersDepressionColorectal Neoplasms

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Marco La Torre, MD

    University of Roma La Sapienza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, PhD

Study Record Dates

First Submitted

September 10, 2011

First Posted

September 13, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2012

Study Completion

June 1, 2012

Last Updated

June 6, 2012

Record last verified: 2012-06

Locations

IT(1)