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RecruitingNCT03001180Updated Nov 6, 2024

Identification of Biomarkers for Patients with Vascular Anomalies

An observational study in Vascular Anomaly, Generalized Lymphatic Anomaly and Kaposiform Hemangioendothelioma, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 2 sites in United States. Open to participants aged 1 Day and older. Per ClinicalTrials.gov, last updated 2024-11-06.

Sponsored by Children's Hospital Medical Center, Cincinnati · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
1,000
Ages
1 Day and older
Sex
All
01

Study 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. 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.

02

Conditions studied

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

Keywords

  • Generalized Lymphatic Anomaly
  • Vascular Anomaly
  • Kaposiform Hemangioendothelioma
  • Kaposiform Lymphangiomatosis
  • Vascular Endothelial Growth Factor
  • Biomarkers
  • GLA
  • KLA
  • KHE
  • GSD
03

Who can participate

Ages eligible
1 Day and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

Exclusion Criteria:

  • N/A
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

  1. Correlation of Biomarkers with Differential Diagnosis

    Time frame: An Average of Every 2 Years

  2. Correlation of Biomarkers with Disease Severity

    Time frame: An Average of Every 2 Years

  3. Correlation of Biomarkers with Response to Therapies

    Time frame: An Average of Every 2 Years

06

Study locations

1 of 2 sites recruiting
  • Boston Children's Hospital
    Boston, Massachusetts 02115, United States
    Terminated
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
    • Megan Metcalf · Contact · hvmcresearch@cchmc.org · 513-803-2606
    • Timothy LeCras, PhD · Contact
    • Adrienne Hammill, MD, PhD · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03001180
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Lymphangiomatosis and Gorham's Disease Alliance (LGDA), Klippel Trenaunay (KT) Support Group, CLOVES Syndrome Community Support Group
Responsible party
Sponsor
First posted
Dec 22, 2016
Start date
Apr 2015
Primary completion
Dec 2050 (estimated)
Completion
Dec 2050 (estimated)
Last update
Nov 6, 2024

Study contacts

Timothy LeCras, PhD
Contact
hvmcresearch@cchmc.org
5138034862
Timothy LeCras, PhD
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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