RECRUITING

Understanding and Addressing Disparities in Cancer Therapy Induced Inflammation and Associated Endothelial Dysfunction

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Very little is understood about the off-target vascular mechanisms of anti-cancer drug toxicity and the impact of exercise on these changes. Much of what has been learned about molecular pathways regulating vascular endothelial function has been established by logical expansion of knowledge obtained through experimental studies (e.g., discovery of endothelium-derived relaxing factor/nitric oxide). Within the last 10 years technological advancements of -omics approaches, such as RNA-sequencing and shotgun proteomics, have dramatically reduced the cost and technical challenge of accessing these tools for discovery-based research. Investigators are now able to obtain unbiased datasets showing changes in transcript or protein expression within complex samples. With cost and accessibility of sequencing is no longer being substantial bottleneck, one of major challenges researchers now face is determining how to meaningfully interpret profiles from large datasets. The extensive characterization of molecular pathways impacting inflammatory responses, endothelial function and angiogenesis, the pathway and network analysis tools will be an asset for identification molecular pathways relevant to alterations in microvascular endothelial function. The investigators preliminary studies on only a small number of samples highlights this potential of the proposed approach to lead to identify personalized medicine-based profiles that will predict patients are likely to develop microvascular endothelial dysfunction from CTx.

Official Title

DECODE Heartland: Understanding and Addressing Disparities in Cancer Therapy Induced Inflammation and Associated Endothelial Dysfunction

Quick Facts

Study Start:2022-03-01
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05223322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult (≥ 18 years) assigned female sex at birth
  2. * Diagnosed with invasive non-metastatic breast cancer
  3. * Receiving neo-adjuvant CTx (or adjuvant CTx and undergoing breast conserving surgery) that includes anthracyclines (such as DOX) and/or targeted anti-Her2 therapy
  4. * Able to safely participate in moderate exercise and strength training based on MD approval
  5. * Willing to complete all study activities
  6. * Self-identifies as Black/African American or non-Hispanic White
  1. * Unintentional weight loss \> 10% in the past 6 months
  2. * Current pregnant and lactating patients. Must have completed lactation prior to study start
  3. * Metastatic disease
  4. * Diagnosed cardiovascular disease as evidenced by cardiomyopathy (reduced regional or global LV contractility), diastolic dysfunction grade 2 or above, symptomatic coronary - artery disease, ejection fraction below 50%
  5. * History of prior chemotherapy or targeted H2N Treatment received less than 3 years ago
  6. * Non-English speaking

Contacts and Locations

Study Contact

Melinda Stolley, PhD
CONTACT
414-955-7533
mstolley@mcw.edu
Courtney Jankowski, MPH
CONTACT
(414) 955-8325
cjankowski@mcw.edu

Study Locations (Sites)

University of Illinois Chicago
Chicago, Illinois, 60607
United States
Medical College of Wisconsin
Wauwatosa, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-01
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2022-03-01
Study Completion Date2026-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer