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Tumor Registry of Lymphatic Neoplasia (TLN-Registry)

This study is currently recruiting participants.
Verified September 2012 by iOMEDICO AG
Sponsor:
Information provided by (Responsible Party):
iOMEDICO AG
ClinicalTrials.gov Identifier:
NCT00889798
First received: April 28, 2009
Last updated: September 17, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this registry is to record information on therapy reality of malignant lymphatic systemic diseases in Germany. The outcome of this registry will describe course of disease and therapy sequences. On basis of anamnestic data, therapeutic decision processes, therapy sequences and therapy results the development of a prognostic score is intended.


Condition
Malignant Lymphatic Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiological Registry Describing Treatment Reality and Therapy Modalities of Patients With Malignant Lymphatic Systemic Diseases (Non-Hodgkin`s Lymphoma, Chronic Lymphocytic Leukemia and Multiple Myeloma) Requiring Therapy.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by iOMEDICO AG:

Primary Outcome Measures:
  • Documentation of anamnestic data and therapy sequences [ Time Frame: 5 years per patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Documentation of response rates and progression-free survival per therapy sequence, overall survival time and adverse reactions [ Time Frame: 5 years per patient ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3000
Study Start Date: April 2009
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with a malignant lymphatic disease
Patients with a malignant lymphatic systemic disease requiring therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with a malignant lymphatic disease requiring therapy

Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Non-Hodgkin`s lymphoma, chronic lymphocytic leukaemia or multiple myeloma
  • Must receive a first- or second-line therapy
  • 18 years or older
  • Signed, written informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889798

Contacts
Contact: iOMEDICO AG +49 761 152420 info@iomedico.com

Locations
Germany
Multiple Sites All Over Germany Recruiting
Multiple Sites, Germany
Contact: iOMEDICO AG     +49 761 152420     info@iomedico.com    
Sponsors and Collaborators
iOMEDICO AG
  More Information

No publications provided

Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT00889798     History of Changes
Other Study ID Numbers: IOM-TLN
Study First Received: April 28, 2009
Last Updated: September 17, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by iOMEDICO AG:
Malignant lymphatic disease
therapy-reality
observation
registry
therapy sequences
NHL
CLL
Germany
lenalidomide
alemtuzumab
rituximab
bendamustin
 thalidomide
bortezomib
ibritumomab-tiuxetan
G-CSF
chronic lymphocytic leukaemia
follicular lymphoma
gastric MALT lymphoma
nongastric MALT lymphoma
nodal marginal zone lymphoma
splenic marginal zone lymphoma
mantle cell lymphoma
diffuse large b-cell lymphoma

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphatic Diseases
Leukemia, B-Cell
Leukemia
 Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013