TLN-Registry: Tumor Registry of Lymphatic Neoplasia

Sponsor

iOMEDICO AG (Industry)

Overall Status

Completed

CT.gov ID

NCT00889798

Collaborator

(none)

3,795

Enrollment

125

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this registry is to record information on therapy reality of malignant lymphatic systemic diseases by office-based haematologists in Germany.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma (NHL) Chronic Lymphocytic Leukemia (CLL) Multiple Myeloma (MM)

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

3795 participants

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.

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Aug 31, 2019

Actual Study Completion Date :

Aug 31, 2019

Outcome Measures

Primary Outcome Measures

Course of treatment (treatment reality) [5 years per patient]
Documentation of anamnestic data and therapy sequences

Secondary Outcome Measures

Effectiveness of treatment [5 years per patient]
Documentation of response rates and progression-free survival per therapy sequence, overall survival time and adverse reactions

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

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