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    • David Wallace BioDavid Wallace - MPN Patient Advocate

      David Wallace

      Founder & CEO of MPN Cancer Connection and PV Reporter | Patient Advocate

      When David was diagnosed with PV in 2009, at the age of 47, he soon learned there was limited and often conflicting information available on Myeloproliferative Neoplasms (MPNs). He also realized early on in his diagnosis, the importance of advocating for himself to best manage his polycythemia vera (PV). David was grateful for the early support and guidance of fellow MPN patients on his journey and wanted a way to give back to the MPN community. With a professional background in business administration and sociology, David has a passion for finding solutions and helping others. In 2013, David used his skill set to create PV Reporter,
      a comprehensive patient-focused website for MPNs. David refers to his site as a hub for patients to begin to research their cancer. Whether a patient, caregiver or healthcare provider, PV Reporter offers visitors a wealth of educational resources, patient stories, articles, and the latest news on the treatment for MPNs, helping MPN patients and their caregivers stay informed, connected and empowered. In 2015, along with the help of others, David founded a non-profit MPN Cancer Connection (MPN-CC), a patient-led 501©3 formed to create awareness that MPN patients are “cancer patients” and should have complete access to local and national programs and benefits. David’s philosophy is to educate patients to become their own advocates so that they can make informed decisions on their treatment. David’s dedication to the MPN community is further evidenced through his work and awards:
      • Selected to endorse 2018 NCCN guidelines for MPN patients by MPN Cancer Connection
      • Selected to represent the United States as a patient advocate by MPNs Advocate Network International Conference 2016-2019
      • Recipient of MPN Hero Award 2016
      • Published in MD Anderson Cancer Center MPN Focus Newsletter Fall 2016
      • Appearance on “The Doctors” TV show in 2015 to promote MPN awareness
      • Awarded Press Credentials for American Society of Hematology Conference 2014-2019
      • Contributor to Patient Power MPN educational videos
      David lives in Charlotte, North Carolina. When he’s not working, David enjoys spending time with family, listening to live music, attending outdoor festivals, watching the Carolina Panthers, riding his motorcycle, traveling and of course having his beloved Aussiedoodle Bailey by his side.
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Clinical Trial Finder

Clinical Trial Finder

Search Results

Ex Vivo Drug Sensitivity Testing and Mutation Profiling

Study Purpose

This study is a prospective, non-randomized feasibility study. Freshly isolated tumor cells from patients will be screened using state-of-the-art viability assay designed for ex vivo high-throughput drug sensitivity testing (DST). In addition, genetic information will be obtained from cancer and normal (germline) tissue and correlated with drug response. This study will provide the platform for informing treating physician about individualized treatment options. The main outcome of this study will be the proportions of the patients whose treatment was guided by the personalized medicine approach.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 1 Day - 21 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients aged 21 years or younger at the time of enrollment on this study of any gender, race or ethnicity.
  • - Subjects with suspected or confirmed diagnosis of recurrent or refractory cancer.
  • - Subjects who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers) - Subjects willing to have a blood draw or buccal swab done for the purposes of genetic testing.
  • - Subjects or their parents or legal guardians willing to sign informed consent.
  • - Subjects aged 7 to 17 willing to sign assent.

Exclusion Criteria:

  • - Subjects who do not have malignant tissue available and accessible.
  • - The amount of excised malignant tissue is not sufficient for the ex vivo drug testing and/or genetic profiling.
  • - Patients with newly diagnosed tumors and tumors that have high (>90%) cure rate with safe standard therapy.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03860376
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Florida International University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Diana Azzam, PhDDaria Salyakina, PhD
Principal Investigator Affiliation Florida International UniversityNicklaus Children's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Large Cell Lymphoma, Refractory Childhood Acute Lymphoblastic Leukemia, Refractory Childhood Hodgkin Lymphoma, Refractory Childhood Malignant Germ Cell Neoplasm, Recurrent Childhood Brain Tumor, Recurrent Childhood Brainstem Glioma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Childhood Ependymoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Gliosarcoma, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Additional Details

PRIMARY OBJECTIVE: The primary objective of the study is to determine feasibility of providing pediatric cancer patients with access to personalized treatment options and clinical management recommendations based on ex vivo drug sensitivity testing (DST) and genomic profiling. SECONDARY OBJECTIVE: The secondary objective of the study is to compare individual outcomes (response and disease-free survival) in patients with pediatric cancers treated with DST-guided therapy as compared to non-DST guided (conventional) therapy. EXPLORATORY OBJECTIVE: To explore associations between genetic abnormalities in malignancies and ex vivo drug response.

Arms & Interventions

Arms

: Chemorefractory or relapsed patients

We intend to enroll chemorefractory or relapsed pediatric patients with all types of cancers where tumor tissue would be available for ex vivo drug screening and genomic profiling. The results of the drug sensitivity assay and genetic screening will be used to inform treating physician about patient-specific drug sensitivity or resistance guiding best therapy choices.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Nicklaus Children's Hospital, Miami, Florida

Status

Recruiting

Address

Nicklaus Children's Hospital

Miami, Florida, 33155

Site Contact

Daria Salyakina, PhD

daria.salyakina@nicklaushealth.org

305-663-8592

Nearest Location

Site Contact

Daria Salyakina, PhD

daria.salyakina@nicklaushealth.org

305-663-8592

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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