Clinical trial NCT04172467: Quality Assurance of Secondary Immunodeficiencies (SID) in CLL/MM Patients
Official title: Quality Assurance on Diagnosis and Therapy of Secondary Immunodeficiencies (SID) in Patients With Chronic Lymphocytic Leukemia (CLL) or Multiple Myeloma (MM) in Germany (QS-SID)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Immunodeficiencies (SID)
Keywords: Secondary immunodeficiencies (SID)
Chronic lymphocytic leukemia (CLL)
Multiple myeloma (MM)
Lead sponsor: AIO-Studien-gGmbH
Sponsor class: OTHER
Collaborators: name: Prof. Hartmut Link
name: Takeda
name: MMF GmbH
name: AIO AG Supportivtherapie
name: AG Supportive Maßnahmen in der Onkologie
First posted: 2019-11-21
Enrollment: 1086
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic lymphocytic leukemia (CLL) or multiple myeloma (MM).

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.

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

Primary outcomes:
measure: Guideline Adherence (GLAD)
timeFrame: Median study observation period of 18.2 months
Secondary outcomes:
measure: Guideline Adherence and Susceptibility to Infection
timeFrame: Median study observation period of 18.2 months
Other outcomes:
Locations:
city: Kaiserslautern
country: Germany
facility: Privatärztliche Praxis; Innere Medizin, Hämatologie, Internistische Onkologie
Study officials:
affiliation: AIO AG Supportive Therapie
name: Hartmut Link, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: