Identification of Biomarkers for Patients with Vascular Anomalies

NCT ID: NCT03001180

Last Updated: 2024-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2050-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Vascular Anomaly Generalized Lymphatic Anomaly Kaposiform Hemangioendothelioma Kaposiform Lymphangiomatosis Gorham-Stout Disease Klippel Trenaunay Syndrome Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* N/A
Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lymphangiomatosis and Gorham's Disease Alliance (LGDA)

UNKNOWN

Sponsor Role collaborator

Klippel Trenaunay (KT) Support Group

UNKNOWN

Sponsor Role collaborator

CLOVES Syndrome Community Support Group

UNKNOWN

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Timothy LeCras, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status TERMINATED

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Timothy LeCras, PhD

Role: CONTACT

5138034862

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Megan Metcalf

Role: primary

513-803-2606

Timothy LeCras, PhD

Role: backup

Adrienne Hammill, MD, PhD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CCHMC-LMI

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of Kidney Tumors in Younger Patients
NCT00898365 ACTIVE_NOT_RECRUITING
Analysis of Biomarkers in Lymph Node Tissue
NCT04228796 ACTIVE_NOT_RECRUITING