NCT01397916

Brief Summary

The Activity of Indoleamine 2,3-dioxygenase in patients with Chronic Lymphocytic Leukemia (CLL) is studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2010

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

February 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
Last Updated

April 19, 2024

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

May 18, 2010

Last Update Submit

April 18, 2024

Conditions

CLL

Keywords

CLLIDO

Outcome Measures

Primary Outcomes (1)

  • IDO activity and expression measured by kynurenine/tryptophan ratio in serum and by PCR in peripheral blood mononuclear cells.

    Indoleamine 2,3 -dioxygenase (IDO) activity in patients with CLL was measured by the serum kynurenine/tryptophan (kyn/trp) ratio and - the expression of INDO (encoding IDO enzyme) and INDOL1 (encoding IDO2 enzyme) genes in peripheral blood mononuclear cells via TaqMan real-time PCR.

    3 months

Study Arms (2)

CLL-patients

Controls

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with CLL

You may qualify if:

  • Patients with CLL and lymphocyte count \> 10 x 109/l

You may not qualify if:

  • Acute infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere university Hospital

Tampere, 33521, Finland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Ido expression

Study Officials

  • Marjatta Sinisalo, MD, PhD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 18, 2010

First Posted

July 20, 2011

Study Start

February 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 19, 2024

Record last verified: 2022-02

Locations

FI(1)