Quality Assurance of Secondary Immunodeficiencies (SID) in CLL/MM Patients

NCT ID: NCT04172467

Last Updated: 2022-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1086 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-28
• Study Completion Date: 2020-08-03

Brief Summary

Retrospective, representative registry for quality assurance on diagnosis and therapy of secondary immunodeficiencies (SID) in patients with chronic lymphocytic leukemia (CLL) or multiple myeloma (MM)

Detailed Description

Treatment structure analysis and recruitment (phase 1):

In a first step, data on care facilities, that treat patients with CLL or MM in Germany is obtained.

In phase 1 all centers in Germany that potentially treat patients with the CLL or MM are contacted and data of its facility care level and its number of treated patients is recorded using a one-sided pen-to-paper form. In addition, the willingness of care facilities to become involved in patients' documentation is elicited (phase 2).

Patient documentation (phase 2)

To achieve a reliable, representative sample of patients treated in Germany, the distribution of cases to be documented is specified in the individual indications amongst the facilities involved. This is done using the facilities' data on patient numbers and treatment structure obtained in phase I:

The participating centers are assigned to clusters based on key distinguishing features (facility type, care level and number of patients treated). This sample is modulated according to the previous treatment structure analysis. By taking this approach, the actual percentages of the various care facilities in an indication area can be reflected proportionally in the patient documentation sample.

In phase 2 a electronic case record form (eCRF) is completed in order to collect the original patient and treatment data, which are relevant to the purpose of the study. All data is gathered retrospectively and anonymously using the patient files. Patient and disease related variables (age, general condition according to the Eastern Cooperative Oncology Group (ECOG), relevant comorbidity, staging and relevant mutations), systemic antineoplastic treatment (chemotherapy, antibodies, kinase-inhibitors, relevant co-medication etc.) are recorded. Also, data on diagnosis of Ig-levels (IgG, IgA, IgM), therapy of secondary immunodeficiencies as well as the number and severity of occurred infections and their treatment is collected. Clusters for classification of infections will be developed (e.g. life-threatening, need for hospitalization).

In order to ensure data quality, the scientific project lead will provide training for two employees of the commissioned institute on matters regarding the content of the study. This knowledge will be incorporated into the programming of the user interface and the patient databases so that the program will check for completeness and, as far as possible, plausibility, on the basis of defined requirements and constraints. These checks accompany the process of entering data into the eCRF and allow for validating data instantly. If inconsistencies, mistakes or omissions are detected, data will be validated by an integrated query management system.

Physicians questionnaire (phase 3)

In an additional step and alongside the patient documentation, the attending physicians in participating centers will be surveyed (phase 3) on their competency profile, their assessment of guideline quality and their approach to avoid infections of CLL and MM patients.

Conditions

Secondary Immunodeficiencies (SID)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

non-interventional retrospective epidemiological observational study

non-interventional retrospective epidemiological observational study

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients with CLL or MM
• anti-neoplastic systemic therapy (all therapy lines) between July 1st 2017 and June 30th 2018

Exclusion Criteria

• patient in terminal phase of the disease, life expectancy less than three months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Hartmut Link

UNKNOWN

Sponsor Role: collaborator

Takeda

INDUSTRY

Sponsor Role: collaborator

MMF GmbH

INDUSTRY

Sponsor Role: collaborator

AIO AG Supportivtherapie

OTHER

Sponsor Role: collaborator

AG Supportive Maßnahmen in der Onkologie

OTHER

Sponsor Role: collaborator

AIO-Studien-gGmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hartmut Link, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

AIO AG Supportive Therapie

Locations

Privatärztliche Praxis; Innere Medizin, Hämatologie, Internistische Onkologie

Kaiserslautern, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AIO-SUP-0119ass (QS SID)

Identifier Type: -

Identifier Source: org_study_id