Unfortunately, there is no cure for CLOVES. Surgery and other types of medical interventions are the primary treatments for CLOVES overgrowth, vascular anomalies and other related medical issues. However there are many current opportunities for you to participate in research.
Please read below about research opportunities and new targeted treatment medications to treat CLOVES/PROS.
Now Recruiting: Paid Online Survey Study for Patients and Caregivers
Patients and caregivers of patients in the US diagnosed with PIK3CA-related Overgrowth Spectrum (PROS) are invited to participate in a paid patient survey. The study is sponsored by Novartis Pharmaceuticals Corporation, working in partnership with researchers at QualityMetric and Global Perspectives. If eligible, your time will be compensated with $60 for each completed survey, which will likely take about 15-30 minutes. You may also be invited to participate in an optional 60-minute telephone or webcam interview (participants receive $75).
This study will include patients and caregivers of patients with PROS, which consists of a wide spectrum of diagnoses. More information regarding eligibility and study compensation is included in the attached flyer. Study results can be shared with interested individuals as available.
Participation in this survey is completely voluntary. Please click here for an online screener to see if you are eligible to participate.
You can also contact Global Perspectives using the contact information below. A team member will get back to you within 1-2 business days.
· [email protected], or
· 1-518-768-7995 (operates 4 AM to 4 PM ET, leave your name and phone number if you reach the voicemail and a team member will return your call)
Now Recruiting: Research Opportunity for people with Microcystic Lymphatic Malformations
This is a phase 2 clinical study in patients with microcystic LM.
This is an open label study (all patients participating in the study receive drug) for patients ages 13 and up who have a diagnosis of a microcystic LM.
If you are interested in participating in this study, complete the short survey below.
This study is open to adult patients and caregivers over the age of 18, who live in the United States. Participants will receive $40 for their time. If you are interested, please complete this form. Contact Dr. Bryan Sisk with any questions at [email protected]
This is a prospective Phase II multi-center study with an upfront 16-week, randomized, double-blind, placebo-controlled period, and extension periods, to assess the efficacy, safety and pharmacokinetics of alpelisib in pediatric and adult participants with PIK3CA-related overgrowth spectrum (PROS). Enrollment is currently open in Norway, Spain, Germany, Switzerland and in the United States: UNC Chapel Hill, Washington University and UCLA.
Purpose: To identify biomarkers in patients diagnosed with a vascular anomaly*.
Who is eligible: Any participant with a diagnosed vascular anomaly* that are currently not on treatment for the condition and are having labs (blood) drawn as standard of care.
*Vascular anomalies included: Generalized Lymphatic Anomaly (GLA), Gorham-Stout Disease (GSD), Kaposiform Hemangioendothelioma (KHE), Kaposiform Lymphangiomatosis (KLA), Klippel Trenaunay Syndrome (KT), Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi Syndrome (CLOVES)
For more information call or email Megan Metcalf at 513-803-2606 [email protected]
The genetics of AVMs are poorly understood, and many theories currently exist with regards to their development, including the hypothesis that their development begins early in gestation. Kahle Lab is actively recruiting patients with brain or spinal cord AVMs and their families. Participants must have a formal diagnosis based on imaging. This study is currently open to people in the United States.
If you are interested in participating, please email [email protected] with the following information:
- Mailing Address or Addresses where the swabs and paperwork will be sent
- Active contact telephone number
- Full Names and Ages of participants at each address that will provide DNA samples in your household
- Previously referred to genetics? If so, findings?
8/28/20 – VT30-101 is a 2-part first-in-human trial of topically administered VT30 to subjects with cutaneous venous malformations, lymphatic malformations, or mixed venolymphatic malformations associated with PIK3CA or TEK mutations.
Part 1 is a 4-week treatment, open-label, 4-sequence, escalating repeat-application cohort study, with intra-subject and inter-cohort dose escalation.
Part 2 is a 12-week treatment, randomized, placebo-controlled, double-blind, safety and exploratory efficacy study. Part 2 will be initiated only after the successful completion of Part 1 with results that demonstrate the general safety and tolerability of topically applied VT30. Up to 12 subjects who complete Part 1 may be enrolled into Part 2 of the study.
The primary objective is to evaluate the safety and tolerability of VT30. The study will also determine the dose and regimen of VT30 to be carried into Part 2 of the protocol. Other aims include documenting plasma drug levels of VT30 and VT10 and, on an exploratory basis, examining pharmacologic target engagement and change in potential efficacy readouts.
Compassionate Use Access of PIQRAY (formerly BYL719/alpelisib) [7-9-19]
The Novartis Managed Access Program (MAP) for PIQRAY use in PROS is available to patients in the US where PIQRAY is available for commercial use (as well as other countries where not approved).
The FDA approved PIQRAY for HR+/HER2- advanced breast cancer, and thus PROS patients may seek access to the medication through MAP.
Patients should contact their treating physicians who can, if clinically appropriate, make a request to Novartis for access to treatment using this link on the Novartis website https://www.novartis.com/our-focus/healthcare-professionals/managed-access-programs
Opportunity for CLOVES Research (ongoing)
April 23, 2013 – Research Opportunity with National Institutes of Health (NIH)