RECRUITING

Molecular Mechanisms Associated With Breast Implant Complications

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

Bacterial biofilms cause implant failures, chronic inflammation, and immune polarization. The study investigates the possible role of bacterial biofilm as a factor in the etiology of Breast Implant Illness. Three patient cohorts will be studied (A) Subjects with breast implant with BII manifestations (B) Subjects with breast implants without BII manifestations (C) Subjects without breast implants who underwent breast surgery procedure. Blood, surgically discarded tissue, implants, and associated capsules will be collected through this protocol.

Official Title

Molecular Mechanisms Associated With Breast Implant Complications

Quick Facts

Study Start:2021-01-03
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05736354

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
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Individuals who are deemed unable to understand the procedures, risks, and benefits of the study, (i.e., unable to provide informed consent)
  2. * Pregnant females
  3. * Immunodeficiency (HIV/AIDS, SCID)
  4. * Currently on immunosuppressive medications
  5. * Prisoners

Contacts and Locations

Study Contact

Mithun Sinha, PhD.
CONTACT
3172782713
mitsinha@iu.edu
Bryce Hockman
CONTACT
3172782715
bbhockma@iu.edu

Principal Investigator

Mithun Sinha, PhD.
PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine

Study Locations (Sites)

IU Health North Hospital
Carmel, Indiana, 46032
United States
Meridian Plastic Surgeons
Carmel, Indiana, 46290
United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Mithun Sinha, PhD., PRINCIPAL_INVESTIGATOR, Indiana University School of Medicine

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 Date2021-01-03
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2021-01-03
Study Completion Date2028-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Implant; Complications
  • Infection or Inflammation