Register of Blood Stem Cell Transplantation | NCT04263857

Studies
Register of Blood Stem Cell Transplantation

NCT04263857

Sponsor

Technical University of Munich

Status

Recruiting

Last Update Posted

Nov 24, 2023Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Hematologic Malignancies

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2017Actual

Primary Completion Date

Nov 2037Estimated

Completion Date

Nov 2037Estimated

First Submitted Date

Mar 2, 2018

First Submission Date that Met QC Criteria

Feb 10, 2020

First Posted Date

Feb 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2023

Last Update Posted Date

Nov 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

20 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

signed IC
patients eligible for stem cell transplantation

Exclusion Criteria:

unable to consent to study participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

all adults, Age >= 18 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mareike Verbeek, MD	Contact	+49 89 4140	5336	mareike.verbeek@tum.de

Overall Officials

Name	Affiliation	Role
Mareike Verbeek, MD	Klinikum rechts der Isar der TU Munich, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum rechts der Isar der TU München	Recruiting	Munich		81675	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019337	Hematologic Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided