Vascular AnomalyNCT03001180
Identification of Biomarkers for Patients with Vascular Anomalies
An observational study of Vascular Anomaly and Generalized Lymphatic Anomaly, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
Trial summary
The study will use blood (serum and plasma) and tissue obtained from participants undergoing prescribed surgical resection of vascular anomalies of interest proposed in this study. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Vascular Anomaly, Generalized Lymphatic Anomaly, Kaposiform Hemangioendothelioma
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2015to Dec 2050
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any participant having labs drawn as standard of care will have blood drawn for the study if consented/assented. All participants who are undergoing a surgical procedure or sclerotherapy are currently consented for participation in the tissue bank. The principle investigator will be looking at tissue from these participants. There is no further recruitment for the study.
Who may be able to join
- Any patient having labs drawn as standard of care will have blood drawn for the study if consented/ assented.
- All patients who are undergoing a surgical procedure or sclerotherapy are currently consented for participation in the tissue bank.
Who cannot join
- N/A
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Terminated
Boston Children's Hospital
Boston, Massachusetts, 02115
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Megan Metcalf, 513-803-2606, hvmcresearch@cchmc.org
Timothy LeCras, PhD
About this study
The study will use blood (serum and plasma) and tissue obtained from participants undergoing prescribed surgical resection of vascular anomalies of interest proposed in this study. The study will also use blood (serum and plasma) and tissue collected and stored in a tissue bank maintained by the Department of Hematology/Oncology.
Read the detailed description
While vascular anomalies are rare diseases, they can be life-threatening and devastating to affected children and their families. Advances in diagnosis, monitoring and therapies will be significantly improved if non-invasive biomarkers that are sensitive and specific can be identified. Obtaining a tissue biopsy to help in diagnosis can actually worsen the disease and so identification of specific blood biomarkers is highly desirable. Studies will measure angiogenic factors in serum and plasma samples at baseline and on therapy. Tissue removed during surgical resection or blood removed prior to sclerotherapy will be used to obtain cells and tissue for the assessment of where biomarkers are coming from and to identify disease-causing pathways for new therapeutic targeting.
- Conditions
- Vascular Anomaly, Generalized Lymphatic Anomaly, Kaposiform Hemangioendothelioma, Kaposiform Lymphangiomatosis, Gorham-Stout Disease, Klippel Trenaunay Syndrome
- Keywords
- Generalized Lymphatic Anomaly, Vascular Anomaly, Kaposiform Hemangioendothelioma, Kaposiform Lymphangiomatosis, Vascular Endothelial Growth Factor, Biomarkers, GLA, KLA, KHE, GSD
- Medical subject headings
- Vascular Malformations, Kaposiform Hemangioendothelioma, Osteolysis, Essential, Klippel-Trenaunay-Weber Syndrome, Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Biomarkers with Differential Diagnosis
Measured: An Average of Every 2 Years
Correlation of Biomarkers with Disease Severity
Measured: An Average of Every 2 Years
Correlation of Biomarkers with Response to Therapies
Measured: An Average of Every 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study startApr 2015
- Primary completionDec 2050 (estimated)
- Study completionDec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AnomalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Lymphangiomatosis and Gorham's Disease Alliance (LGDA), Klippel Trenaunay (KT) Support Group, CLOVES Syndrome Community Support Group
- Responsible party
- Sponsor
- Investigators
- Timothy LeCras, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001180
- Sponsor's protocol ID
- CCHMC-LMI
- Status last verified
- Oct 2024
- First submitted
- 15 Dec 2016
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No