Tumor Registry of Lymphatic Neoplasia (TLN-Registry)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
iOMEDICO AG
ClinicalTrials.gov Identifier:
NCT00889798
First received: April 28, 2009
Last updated: June 27, 2016
Last verified: June 2016
  Purpose
The purpose of this registry is to record information on therapy reality of malignant lymphatic systemic diseases by office-based haematologists in Germany.

Condition
Non-Hodgkin's Lymphoma (NHL)
Chronic Lymphocytic Leukemia (CLL)
Multiple Myeloma (MM)

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:


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: 3750
Study Start Date: April 2009
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Detailed Description:

The TLN is a prospective, longitudinal, nation wide cohort study with the purpose to record information on the antineoplastic treatment of lymphatic neoplasms in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

The impact of nutrition (LyNut) and physical activity (LyNut) on the course of the adjuvant disease will be examined in patients with indolent and aggressive Non-Hodgin Lymphoma, as well as long-term effects of systemic treatment (LyTox) and quality of life (LyLife) in patients with multiple myeloma.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Exclusion Criteria:

- no systemic therapy

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889798

Sponsors and Collaborators
iOMEDICO AG
Investigators
Study Chair: Wolfgang Knauf, MD Center for Haematology, Frankfurt, Germany
Study Chair: Wolfang Abenhardt, MD MVZ Onkologie im Elisenhof, München, Germany
  More Information

Publications:
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: June 27, 2016
Health Authority: Germany: Ethics Commission
Individual Participant Data  
Plan to Share IPD: No

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:
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Leukemia, B-Cell

ClinicalTrials.gov processed this record on August 22, 2016