Register of Blood Stem Cell Transplantation (REBB3M)

Register of Survey and Evaluation of Blood Stem Cell Transplantations of Clinic III of Internal Medicine III

Register of patients with blood stem cell transplantations (autologous, allogen).

Study Overview

• Status: Recruiting
• Conditions: Hematologic Malignancies

Detailed Description

Documenting the success rate in terms of complication rate, disease response, survival rate, engraftment, and details of transplantation settings, for example donor and conditioning data, remission status before transplantation.

It's a register of patients who have one or more autologous and / or allogenic blood stem cell transplants due to an existing indication for performing myeloablative / non-myeloablative high-dose chemotherapy.

The inclusion occurs at our center during preparation for blood stem cell transplantation. The written consent will be obtained separately in the context of the information on blood stem cell transplantation. Participation is voluntary and consent can be revoked at any time. This involves no additional effort for the patient and has no influence on his treatment. It may be necessary in the course of contacting the patient at home, as long as the data is incomplete. This is also explicitly explained. A copy of the declaration of consent is given to the patient.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Mareike Verbeek, MD; Phone Number: 5336 +49 89 4140; Email: mareike.verbeek@tum.de

Study Locations

• Germany
  • Munich, Germany, 81675
    • Recruiting
    • Klinikum rechts der Isar der TU München
    • Contact: Mareike Verbeek, MD; Phone Number: 5336 +49 89 4140; Email: mareike.verbeek@tum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all adults, Age >= 18 years

Description

Inclusion Criteria:

• signed IC
• patients eligible for stem cell transplantation

Exclusion Criteria:

• unable to consent to study participation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Register of stem cell transplantation	Recording of all stem cell transplantations over many years	approximately over 20 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Register of toxicities	Recording of toxicities occured during and after SCT according to GvHD Score Standards and blood and bone marrow samples, and Imaging (CT Scans)	approximately over 20 years
Register of complications	Recording of complications occurred during and after SCT in Terms of infectious complications and occurance of GvHD (according to GvHD Score and Imaging and clinical assessment)	approximately over 20 years
Register of morbidities		approximately over 20 years
Register of survivals	Recording of survival Status, Assessment of Remission Status by bone marrow and blood diagnostics, clinical follow up	approximately over 20 years

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Mareike Verbeek, MD, Klinikum rechts der Isar der TU Munich, Germany

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): November 1, 2037
• Study Completion (Anticipated): November 1, 2037

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: autologous & allogenic blood stem cell transplantations
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: REBB3M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No