Clinical Trials and Studies
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LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge)
The University of Chicago Medicine has announced that it is now enrolling patients in LymphBridge™, a randomized clinical study to evaluate a novel surgical treatment for addressing breast cancer-related lymphedema (NCT04606030). This study is sponsored by Fibralign Corporation with funding provided by the National Cancer Institute (NCI) and being led by world-renowned microsurgeon Dr. David W. Chang, Professor of Surgery and Chief of the Section of Plastic and Reconstructive Surgery at UChicago Medicine.
LymphBridge: Prospective Evaluation of the BioBridge Scaffold as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema is an FDA-reviewed clinical study that will assess Fibralign’s BioBridge® Collagen Matrix for use in improving outcomes of surgical treatment of lymphedema. BioBridge is a sterile, biocompatible and biodegradable device made of medical-grade collagen that has 510(k) clearance from the FDA for use as a surgical mesh to reinforce and support soft tissue repair. In this study BioBridge will be implanted as part of the lymph node transplant surgery to support repair of damaged lymphatic tissue.
Estimated Primary Completion Date: September 30, 2022
Estimated Study Completion Date: December 15, 2022Contact: Janine Grohar 773-702-0316 jgrohar@bsd.uchicago.edu
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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
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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 -
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 MatrixBioBridge 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 4721For information about the US study, visit: LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge) - Full Text View - ClinicalTrials.gov
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PureTech Health Study of Investigational Treatment for Lymphedema
PureTech Health is conducting a study to evaluate its investigational product candidate, LYT-100 (deupirfenidone), for the potential treatment of breast cancer related lymphedema. PureTech is committed to developing medicines for devastating diseases, and the company believes that LYT-100 has the potential to treat lymphedema.
Men and women between the ages of 18 and 80 with documented breast cancer-related lymphedema may be eligible to participate in this study.
Key Inclusion criteria:
1. Female or male between 18 and 80 years old (inclusive) at the time of informed consent.
2. At least 6 months since any type of breast cancer surgery (excluding fine needle aspiration biopsy [FNA]), at the time of study screening. No intention to have breast reconstructive surgery, nipple reconstruction and/or tattooing during the course of the study.
3. At least 3 months since completion of all types of treatment for breast cancer, including but not limited to neoadjuvant, radiotherapy, chemotherapy and immunotherapy, at the time of study screening.
4. At least 3 months treatment of stable adjuvant treatment with hormonal or anti-HER2 therapy at the time of screening, with no planned changes to this therapy throughout the duration of the study.
5. Diagnosis of primary breast cancer, and without evidence of recurrence of breast cancer and/or metastasis for at least 6 months since breast cancer surgery, as determined at screening and baseline.
6. Documented evidence of Stage 1 or 2 lymphedema.Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021Contacts:
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Christopher Korth: +1 617-226-4813 ckorth@puretechhealth.com
Michael Chen: +1 617-226-4813 mc@puretechhealth.com -
Does Immediate Lymphatic Reconstruction Decrease the Risk of LE After Axillary Lymph Node Dissection
A therapy to prevent lymphedema: Lymphedema, a buildup of lymph fluid that can cause lifelong pain, occurs in about 20 percent of breast cancer patients who have lymph nodes removed or as a result of radiation. Researchers believe immediate lymphatic reconstruction may be the best way to prevent it and are recruiting breast cancer patients up to age 75, half of whom will undergo the reconstruction surgery. “If we find [this] decreases the risk of developing lymphedema, immediate lymphatic reconstruction may become a standard of care,” says lead researcher Michelle Coriddi, MD, of Memorial Sloan Kettering Cancer Center. (NCT04241341)
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Breast Cancer
Accepts Healthy Volunteers: NoInclusion Criteria:
- Female breast cancer patients 18-75 years of age
- Patients consenting for unilateral ALND (prior history of SLNBx allowed if <6 months from consent) OR patients consenting for unilateral SLNBx with possible ALND, with a clinically or radiographically positive lymph node OR a high likelihood of ALND per the Breast Surgeon
- Identification of at least one transected lymphatic channel and at least one vein to be used for bypass at the time of ALND during surgery
Actual Study Start Date: January 22, 2020
Estimated Primary Completion Date: January 2022
Estimated Study Completion Date: January 2022
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Contact: Michelle Coriddi, MD 646-608-8042 coriddim@mskcc.org
Contact: Babak Mehrara, MD 212-639-3099 -
Children’s Friend Study
A Comparison of Caregivers’ Experiences in Accessing Mental Health Treatment for their Children
Are you the parent of a child with a mental health condition, a medical condition, and/or a rare disease?
Participate in a Survey:
Experiences in Accessing Mental Health Treatment.Our names are Kim Hager, LICSW, and Maria Martinez Calderon, LMHC. We both work as outpatient therapists at Children’s Friend, Inc., an affiliate of Seven Hills Foundation, in Worcester, MA. We are interested in studying the experiences in and barriers to accessing mental health services for families. For the purpose of our study, we intend to compare three groups – caregivers of children with one or more mental health conditions, caregivers of children with mental health conditions and common medical conditions, and caregivers of children with mental health conditions and rare disease. Caregivers include biological parents, adoptive parents, foster parents, step-parents, and kinship homes with children under the age of 18. The survey is nationwide and open to families who live anywhere within the United States. The hope is the survey results will assist mental health providers in tailoring services to meet families’ needs.
You are welcome to contact us at Children’s Friend, Inc. at 508-753-5425 with further questions.
Take the survey in English.
Learn More >
Take the survey in Spanish. -
The International Lymphatic Disease and Lymphedema Patient Registry & Biorepository
We invite you to participate in this highly significant development for the patient community. An international patient registry paves the way for future clinical trials of experimental drugs and therapies designed to treat lymphatic diseases. We encourage all patients to participate in this important initiative.
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Biomarker and Phenotypic Risk Factors for Breast Cancer LymphedemaThe University of California San Francisco is conducting a study to investigate these symptoms related to lymphedema. Mount Sinai is a New York City study site where you can enroll in the study locally. Participants who compete the study will receive $150 for their time.
If you are a woman 18 years of age or older and have completed your active treatment (surgery, chemotherapy or radiation) for breast cancer at least six months ago, you may be eligible. We are currently enrolling women with lymphedema.
Study Involves:
- Completion of questionnaires
- One 2-hour visit to The Mount Sinai Hospital that involves:
- Movement & Sensation Evaluation
- Arm & Body Measurements
- Blood Sample CollectionFor more information, contact us by phone at 212-241-8055 or email at Nursing.Research@mountsinai.org.
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Stanford Study On Response To Drug Therapy For Lymphedema
Researchers at Stanford University in Stanford, CA are conducting a study on the response to drug therapy for lymphedema. You may be eligible for this study if you have chronic lymphedema and are eligible for the drug therapy. Participants will not be paid for their participation. The study length is approximately 6 months.
All prospective study subjects who are not current patients of the lymphedema treatment clinic at the Stanford Center for Lymphatic and Venous Disorders must first be evaluated by Dr. Rockson to assess if they are appropriate candidates for the study. There are two study appointments after the initial clinical evaluation. If interested, or for more information, please contact:
Leslie Roche RN, Clinical Research Coordinator Email address: lesroche@stanford.edu
For general information about participant rights, contact 1-866-680-2906.
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Recovery & Rejuvenation ProjectThis is a partnership between the Recovery & Rejuvenation project at Arizona State University, the Mayo Clinic, the University of Arizona, and community organizations in the Phoenix metropolitan area. The purpose of this project is to explore ways of helping women recover from breast cancer. It is very common for breast cancer survivors to report low energy, lack of focus, poor memory or trouble sleeping for months and even years after treatment. The goal of this project is to explore ways to improve energy levels through classes designed to help participants find their way back to wellness.
The project focus is on women who:
o Have been diagnosed with Stage 0 to III breast cancer
o Are 6 months to 10 years past primary treatment
o Age: 45-75Eligibility process:
o 1st step: 10-15 minute pre-screen that goes over health history and diagnosis.
o 2nd step: if eligible after the pre-screen, a 10-15 minute in-person meeting will be scheduled to complete the process and an informed consent will be obtained.Classes:
o Women will be randomly assigned to one of three classes. Two of the classes will focus on gentle movement. The third class will have a book club format and will focus on readings that are designed to educate and support women through their recovery.
o Classes will be scheduled for one hour each week, for a total of 8 consecutive weeks. All class materials will be provided at the first class. The classes will take place at various community site locations throughout the Phoenix Metropolitan area.
o Participants will take part in three health assessments: before and after the eight class sessions, and 24 weeks after classes end. Blood and saliva samples will be collected as well as questionnaires related to diet, sleep and activity level.Benefits:
o Participating women may improve levels of vitality, physical activity, sleep quality, mood, cognitive function, peripheral neuropathy, and inflammation.This research project is supported by the National Cancer Institute of the National Institutes of Health under Award Number R01CA182901.
If you have any questions you can contact us by phone at (602) 496-2329 or by email at recovery.rejuvenation@asu.edu.
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