Last updated: 11/03/2018 20:00:12
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study.

Epidemiological Multinational (Russian Federation, Ukraine, Republic of Kazakhstan) Chronic Lymphocytic Leukemia Retrospective Observational Study (LEUKOSPECT) to Evaluate Medical, Economic and Social Factors in Patients with Chronic Lymphocytic Leukemia.LEUKOSPECT

GSK study ID
117047
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Epidemiological Multinational (Russian Federation, Ukraine, Republic of Kazakhstan) Chronic Lymphocytic Leukemia Retrospective Observational Study (LEUKOSPECT) to Evaluate Medical, Economic and Social Factors in Patients with Chronic Lymphocytic Leukemia.
Trial description: This is a retrospective, descriptive, cohort study of at least 1,000 patients diagnosed with CLL for SoC, and approximately 450 patients for prevalence and incidence, in Russia, Kazakhstan and Ukraine. All data will be collected retrospectively from patient medical records
This study is divided into two parts: 1)SoC: the study will describe the treatment paradigm used in 2013 in the clinical management of Chronic Lymphocytic Leukemia (CLL) in CIS as well as to provide a better understanding of clinical and immunophenotyping characteristics of CLL patients. This information will provide insight into real-world exposure, adherence to treatments regimens, improve understanding of health services utilization, and direct medical costs associated with CLL. Patients with at least 1 visit to the center in 2013 will be included in the study. 2) Prevalence will be assessed on 31 December 2013 in selected cities among the adult population. Local CLL cumulative incidence will be assessed from 2009 to 2013.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Incidence data analysis

Timeframe: 5 years

Prevalence data analysis

Timeframe: -

Clinical, immunophenotyping characteristics and patients with frontile, relapse and refractory CLL

Timeframe: 1 year

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
1450
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Leukaemia, Lymphocytic, Chronic
Product
ofatumumab
Collaborators
Not applicable
Study date(s)
February 2014 to October 2014
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
  • 1.1 Prevalent CLL patient:
  • Diagnosis of CLL before 31 December 2013;
  • Absence of appropriate patient documentation/medical records.
Inclusion and exclusion criteria
Inclusion criteria:
  • 1.1 Prevalent CLL patient:
  • Diagnosis of CLL before 31 December 2013;
  • Resident in the target city on 31 December 2013 (not deceased). 1.2 Incident CLL patient:
  • New diagnosis of CLL between 1 January 2009 and 31 December 2013;
  • Resident in the target city at date of diagnosis 1.3 Standard of Care Study:
  • Age older than 10 at 2009 or year of birth 1991 and earlier;
  • Established diagnosis of CLL before 31 December 2013 provided by physician from medical documentation;
  • At least one visit to the centre, inpatient or outpatient, in medical documentation from 01 January 2013 to 31 December 2013;
  • Centre is patient's primary place for CLL care.
Exclusion criteria:
  • Absence of appropriate patient documentation/medical records.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
2014-03-10

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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