Registry for Patients with Vascular Malformations and Tumors (VasMuT)
Organizational Data
- DRKS-ID:
- DRKS00026788
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2021-10-08
- Last update in DRKS:
- 2024-04-23
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
The VasMuT registry is a retro- and prospective, multicenter registry collecting clinical information on patients with vascular malformations and tumors. For this purpose, clinical (including photographic), radiological, pathophysiological, epidemiological, and genetic data of patients diagnosed with one of these disorders and who have provided an informed consent are documented in a privacy-compliant database. Vascular malformations are congenital disorders of blood vessel development that affect all segments of the vascular system and can lead to corresponding malformations. So there are capillary malformations (CM), venous malformations (VM), lymphatic malformations (LM), and arteriovenous malformations (AVM). These can either be isolated or occur as part of a syndrome with other malformations. Therefore, a registry for patients with vascular malformations and tumors (VasMuT) will be initialized to collect clinical, radiological, laboratory and molecular genetic data of patients with these diseases. Thus, therapy/recommendations and clinical course (outcome) can also be tracked.
Brief summary in scientific language
Vascular malformations include: - Capillary malformations including Sturge-Weber syndrome. - Lymphatic malformations including the complex lymphatic malformations (Generalized lymphatic anomaly (GLA), Kaposiform lymphangiomatosis (KLA), Gorham-Stout disease, Central conducting lymphatic anomaly (CCLA)) - Venous malformations incl. blue rubber bleb nevus syndrome (BRBN), extensive segmental venous malformation, fibro-adipose vascular anomaly (FAVA) - Arteriovenous malformations, incl. intramuscular fast-flow vascular anomaly and also AVMs in syndromal diseases - Syndromal diseases with vascular malformations, incl. CM-AVM / Parkes-Weber syndrome, PIK3CA-related overgrowth spectrum disorders (PROS), Proteus syndrome, subtypes of PTEN hamartoma tumor syndrome A wide spectrum of vascular tumors is known, ranging from benign and spontaneously regressing infantile hemangiomas to highly malignant and difficult to treat angiosarcomas. Benign tumors include the following entities: infantile hemangiomas (including neonatal hemangiomatosis), congenital hemangiomas, pyogenic granulomas (including multifocal congenital pyogenic granulomas), and the epithelioid hemangiomas. The group of locally aggressive and borderline tumors includes: Tufted angioma, Caposiform hemangioendothelioma, Pseudomyogenic hemangioendothelioma. The group of malignant vascular tumors includes: Angiosarcoma, epithelioid hemangioendothelioma. Lymphedema is a congenital or acquired disorder of lymphatic drainage due to malposition, dysfunction or damage of lymphatic vessels. In addition, there are diseases that overlap with lymphedema, such as lipedema, where the exact origin of the disease and its cause are not yet known. These diseases should also be recorded in the registry.
Health condition or problem studied
- ICD10:
- Q27.8 - Other specified congenital malformations of peripheral vascular system
- ICD10:
- Q27.9 - Congenital malformation of peripheral vascular system, unspecified
- ICD10:
- Q28.3 - Other malformations of cerebral vessels
- ICD10:
- D18.1 - Lymphangioma, any site
- ICD10:
- M89.5 - Osteolysis
- ICD10:
- Q82.5 - Congenital non-neoplastic naevus
- ICD10:
- Q27.3 - Peripheral arteriovenous malformation
- ICD10:
- Q87.2 - Congenital malformation syndromes predominantly involving limbs
- ICD10:
- Q85.8 - Other phakomatoses, not elsewhere classified
- ICD10:
- Q27.3 - Peripheral arteriovenous malformation
- ICD10:
- Q28.2 - Arteriovenous malformation of cerebral vessels
- ICD10:
- I78.0 - Hereditary haemorrhagic telangiectasia
- ICD10:
- Q87.3 - Congenital malformation syndromes involving early overgrowth
- ICD10:
- Q82.8 - Other specified congenital malformations of skin
- ICD10:
- Q87.8 - Other specified congenital malformation syndromes, not elsewhere classified
- ICD10:
- Q85.8 - Other phakomatoses, not elsewhere classified
- ICD10:
- Q78.4 - Enchondromatosis
- ICD10:
- Q87.2 - Congenital malformation syndromes predominantly involving limbs
- ICD10:
- D18.0 - Haemangioma, any site
- ICD10:
- C49.9 - Connective and soft tissue, unspecified
- ICD10:
- C22.3 - Angiosarcoma of liver
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- All patient information and clinical data are collected in an electronic record form (eCRF). For the VasMut Registry, these are maintained in the RedCap database. In addition, data may also be collected in the European Reference Network for Vascular Anomalies Registry (VASCERN Registry), which is maintained through the Castor database. This requires that consent has been given for the additional collection of data in the VASCERN Registry. All data will be collected in the registry in pseudonymized form.
Endpoints
- Primary outcome:
- - Continuous registration of all patients with diagnosed vascular malformation or tumor
- Secondary outcome:
- - Documentation of clinical characteristics, treatment and outcome data (disease status, treatment decisions, treatment, quality of life, survival). - Assessment of biological disease characteristics (genetic findings) and correlation with clinical outcome data (prognostic and predictive markers, e.g., response to various forms of therapy)
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Freiburg im Breisgau
- Medical center Földiklinik Hinterzarten
Recruitment period and number of participants
- Planned study start date:
- 2021-10-31
- Actual study start date:
- 2021-10-27
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 1000
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - Clinical diagnosis - No age restriction - Patients (or their legal representatives) have given informed consent
Exclusion Criteria
- Written consent to register participation is not given
Addresses
Primary Sponsor
- Address:
- Universitätsklinik FreiburgZentrum für Kinder- und JugendmedizinPädiatrische Hämatologie und OnkologieDr. med Friedrich KappMathildenstraße 179106 FreiburgGermany
- Telephone:
- +49 761 270 43000
- Fax:
- +49 761 270 46160
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/paed-haematologie.html
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinik FreiburgZentrum für Kinder- und JugendmedizinPädiatrische Hämatologie und OnkologieDr. med Friedrich KappMathildenstraße 179106 FreiburgGermany
- Telephone:
- +49 761 270 43000
- Fax:
- +49 761 270 46160
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/paed-haematologie.html
Contact for Public Queries
- Address:
- Universitätsklinik FreiburgZentrum für Kinder- und JugendmedizinPädiatrische Hämatologie und OnkologieDr. med Friedrich KappMathildenstraße 179106 FreiburgGermany
- Telephone:
- +49 761 270 45210
- Fax:
- +49 761 270 46160
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/paed-haematologie.html
Principal Investigator
- Address:
- Universitätsklinik FreiburgZentrum für Kinder- und JugendmedizinPädiatrische Hämatologie und OnkologieDr. med Friedrich KappMathildenstraße 179106 FreiburgGermany
- Telephone:
- +49 761 270 43000
- Fax:
- +49 761 270 46160
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/paed-haematologie.html
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinik FreiburgZentrum für Kinder- und JugendmedizinPädiatrische Hämatologie und OnkologieMathildenstraße 179106 FreiburgGermany
- Telephone:
- +49 761 270 43000
- Fax:
- +49 761 270 46160
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/paed-haematologie.html
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-03-12
- Ethics committee number:
- 21-1200
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-08-17
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- What data in particular will be shared: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) What other documents will bei available: Study protocol, statistical analysis plan, analytic code When will data be availabel: Beginning 3 months and ending 5 years following article publication With whom: Researchers who provide a methodologically sound proposal For what types of analyses: To achieve aims in the approved proposal By what mechanism will data be made availabel: Proposals should be directed to friedrich.kapp@uniklinik-freiburg.de. To gain access, data requestor will need to sign a data access agreement.
Study protocol and other study documents
- Study protocols:
- VasMuT-Registerprotokoll V2.0_20210628
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry