Clinical Trials and Studies

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• PTX-022 in the Treatment of Microcystic Lymphatic Malformations

  The purpose of this study is to see if a new investigational topical (applied to the skin) formulation of sirolimus, PTX-022 (the study drug), is safe and effective in treating participants with microcystic Lymphatic Malformations.

  
  Eligibility & Criteria
  IRB #:  23-021775
  Official Title:  SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 in the Treatment of Microcystic Lymphatic Malformations
  Study Phase:  Phase III
  Eligible Age Range:  6 - 60 Years
  Gender:  All
  Study Categories:  Adults, Children

  If you are interested in participating in the study or want to learn more please contact our study team at CVAPResearch@chop.edu or 267-426-0743.

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• Alpelisib in PIK3CA Associated Lymphatic Malformations

  This study (IRB #23-021374) has several parts and involves taking a study drug called alpelisib. Some participants enrolled into Stage 2 will receive a placebo for the first part of the study (24 weeks) and will then receive the study drug. The purpose of this study is to find out if the study drug is safe and effective (can help) people with a confirmed diagnosis of lymphatic malformation (LyM) and a documented mutation in the PIK3CA gene.

  Eligibility & Criteria

  Study Phase:  Phase II, Phase III
  Eligible Age Range:  2 - 60 Years
  Gender:  All
  Study Categories:  Adults, Children

  For more information or to participate, contact the study team at CVAPResearch@chop.edu or 267-426-0743.

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• Stanford Arm Lymphedema Drug (HEAL) Study

  Researchers at Stanford University in Stanford, CA are conducting a study on the response to a drug for lymphedema. You may be eligible for this study if you have single arm lymphedema and qualify for the drug therapy. Participants will not be paid for their participation. The enrollment duration is approximately 9 months.

  Key Inclusion Criteria:
  1. Single arm lymphedema
  2. Lymphedema of ≥ 6 months duration.
  3. Male or female.
  4. Ages 18-75.

  The Stanford Center for Lymphatic and Venous Disorders evaluate all prospective participants to assess if they are appropriate candidates for the study. There are four research-related appointments.

  For more information, please contact:
  Marissa Dobry, Clinical Research Coordinator
  Email address: heal-lymphedema-study@stanford.edu

  For general information about participant rights, contact 1-650-725-9820.

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• Lymphedema Patient Survey

  Do you have lymphedema? Please respond to this anonymous on-line survey: Lymphedema Patient Survey

  It will take only 3 minutes, but your participation is extremely important! The data that we collect will help us to inform doctors, hospitals, third party payers and the government about the lymphedema patient experience.

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• Lymphatic Anatomy and Function Study - Breast Cancer Survivors

  Researchers from the Boston Lymphatic Center at Beth Israel Deaconess Medical Center are conducting a study to identify normal variation in lymphatic anatomy in the upper extremities of female breast cancer survivors.  For more information, download the flyer below.

  Flyer_Breast_Cancer_Survivors.pdf

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• Lymphatic Anatomy and Function Study - Healthy Volunteers

  Researchers from the Boston Lymphatic Center at Beth Israel Deaconess Medical Center are conducting a study to identify normal variation in lymphatic anatomy in the upper extremities of healthy volunteers.  For more information, download the flyer below.

  Flyer_Healthy_Volunteers.pdf

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• Analysis of Role Changes for Women with Breast Cancer Related Lymphedema to Return to Work

  IS THIS STUDY RIGHT FOR YOU?

  ❖ Have you been diagnosed with breast cancer related lymphedema?
  ❖ Do you experience difficulty with everyday tasks due to symptoms associated with breast cancer related lymphedema (BCRL)?
  ❖ Are you limited with your ability to perform successfully at work due to symptoms?
  ❖ Do you currently receive rehabilitation services for lymphedema management secondary to breast cancer?
  ❖ Inclusion criteria: female between the ages of 18-65, diagnosed with breast cancer or breast cancer related lymphedema.
  ❖ Exclusion criteria: outside of the age parameters listed in the inclusion, not a female, does not have a diagnosis of breast cancer or breast cancer related lymphedema.

  WHAT WOULD YOU HAVE TO DO?

  ● Participate in a short 15 question internet survey, answering the questions to the best of your ability.
  ● The survey will be anonymized, and no collection of any identifiable information will occur to avoid any violation of protection to the participants.
  ● Private message the study investigator on the Facebook support group to participate in the study.

  
  This study is voluntary and you may withdraw at any time. Your information will be kept confidential and no information that could potentially identify you will be published.

  If you would like to receive more information regarding the study, please contact the investigator for this study:

  Soraya Martinez, Occupational Therapy Doctorate Student at the University of St. Augustine for Health Sciences, Email: s.martinez@usa.edu; Phone number: 407-535-7749

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• An update on the priorities for women living with breast cancer related lymphoedema

  An update on the priorities for women living with breast cancer related lymphoedema and the relationship with severity
  The University of Sydney is conducting an online survey looking at the needs of women living with breast cancer-related lymphoedema.  Participation in this research study is voluntary.  The survey will take approximately 20 minutes to complete.

  Women who have been diagnosed with breast cancer and as a result of treatment and have experienced upper limb swelling (lymphoedema). Women should have completed treatment for their breast cancer (except for hormone treatment) at least 6 months ago and have experienced upper limb lymphoedema for more than 12 months

  A survey will be completed online which will investigate your needs arising from living with upper limb lymphoedema including:
  · The severity of your lymphoedema.
  · How lymphoedema has impacted your daily and working life.

  If you have breast cancer related lymphoedema with access to the internet using a computer, laptop, Ipad or smart phone we would love to hear from you!

  To participate in the survey, click here.

  If you have questions or would like more information about participating, please contact us at jfre8103@uni.sydney.edu.au.

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• Exploring the Quality of life of children and young people with Lymphoedema

  This study aims to explore the Quality of life of children and young people with Lymphoedema and to validate a Lymphoedema specific quality of life tool (LYMPHOQOL) for use with children and young people with Lymphoedema.

  What is the purpose of the study?
  This study aims to explore the Quality of life of children and young people with Lymphoedema and to validate a Lymphoedema specific quality of life tool (LYMPHOQOL) for use with children and young people with Lymphoedema.

  Why have I been invited?
  You are being invited to take part because you or your child are living with Lymphoedema.

  What will happen to me if I take part?
  You will be asked to complete 2 online questionnaires (LYMPHOQOL and KIDSCREEN) that are written in your own language and according to your age. These questionnaires aim to measure your quality of life and understand any worries you may be experiencing.  You will also be asked to tell us what you think about the new LYMPHOQOL questionnaire and how long it took you to complete the online survey.

  Further information and contact details
  Professor Christine Moffatt, CBE,
  Emeritus Professor University of Nottingham,
  Clinical Professor of Skin Integrity,
  Nottingham University Hospitals NHS Trust,
  Nottingham City Hospital,
  Hucknall Road,
  Nottingham,
  NG5 1RB
  Email address: christine.moffatt@cricp.org.uk

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• Fibralign Announces Start of European Lymphedema Prevention Clinical Study

  Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced enrollment of the first patient in a multi-site, randomized clinical trial in Europe evaluating its BioBridge® Collagen Matrix as a novel preventative treatment for secondary lymphedema.

  The study plans to enroll 40 patients that have been diagnosed with advanced stage breast cancer and require axillary lymph node dissection (ALND), a common surgical intervention that involves removal of compromised lymph nodes to address the spread of cancer. Peer reviewed publications have estimated that 15-25% of patients who undergo ALND develop breast cancer-related lymphedema (BCRL) due to the surgery. ALND combined with radiation therapy increases the likelihood of BCRL further up to 40%.

  Led by Dr. Dimitris Dionysiou, Associate Professor in Plastic Surgery at the Aristotle University of Thessaloniki (Greece) and principal investigator, the trial aims to demonstrate the effectiveness of BioBridge as a prophylactic remedy for reducing patient risk in development of lymphedema. This off-the-shelf solution would provide a much-needed treatment that could be utilized as a simple adjunct procedure in support of current cancer interventions, significantly advancing the quality of care for patients.
  
  About BioBridge® Collagen Matrix

  BioBridge is a sterile, biocompatible and biodegradable surgical mesh that recently received CE mark for use in the surgical support of lymphatic tissue repair. The certification mark confirms that BioBridge meets the requirements of the European Medical Devices Directive, which now allows Fibralign to market the product across the European Union and other CE mark countries. BioBridge is also commercially available in the US and has 510(k) clearance from the FDA for use as a surgical mesh to reinforce and repair soft tissue. Published preclinical studies and early clinical usage have shown that BioBridge supports the repair of damaged lymphatic vessels that causes lymphedema.

  About Fibralign Corporation

  Fibralign Corporation is a commercial stage healthcare company that develops and manufactures advanced therapeutic biomedical devices designed to address significant unmet medical needs by utilizing its patented Nanoweave® 3D scaffolding technology. http://www.fibralignbio.com

  Contacts

  In Europe: Albert Huttenga, ahuttenga@fibralignbio.com, +31 651 750 078
  Greg King, CEO/President Fibralign Corp. gking@fibralignbio.com, +1 415 902 4721

  For information about the US study, visit: LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge) - Full Text View - ClinicalTrials.gov

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