RECRUITING

Human Upper Extremity Allotransplantation: F/U Protocol

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

Upper extremity allotransplantation is a new procedure which is becoming more common in the United States. Ongoing data collection for research purposes is vital to the long-term assessment as to the safety of the procedure and accompanying immunosuppression protocol, as well as quantifying patient outcomes and changes in quality of life. For these reasons, The Johns Hopkins Hand/Arm Transplantation Team is interested in enrolling transplanted patients in a follow-up protocol to continue collecting informative data to further the field of vascularized composite allotransplantation.

Official Title

Human Upper Extremity Allotransplantation: Transplanted Patient Follow-Up Protocol

Quick Facts

Study Start:2017-07-25
Study Completion:2036-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03400345

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:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and females 5 or more years post-unilateral or bilateral upper limb transplantation.
  2. * Completes the protocol informed consent form.
  3. * Consents to sample collection and storage (biopsies).
  4. * USA citizen or equivalent.
  5. * Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.
  1. * Candidate has not received an upper extremity allotransplant.
  2. * Any reason the study team thinks would cause the participant to be noncompliant or would put the patient at unacceptable risk if enrolled.

Contacts and Locations

Study Contact

Jane Littleton, C.R.N.P
CONTACT
410-955-6875
jlittl38@jhmi.edu
TBD TBD
CONTACT
443-287-7848

Principal Investigator

Jaimie Shores, M.D.
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Jaimie Shores, M.D., PRINCIPAL_INVESTIGATOR, Johns Hopkins University

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 Date2017-07-25
Study Completion Date2036-07

Study Record Updates

Study Start Date2017-07-25
Study Completion Date2036-07

Terms related to this study

Keywords Provided by Researchers

  • Hand Transplant
  • composite tissue allograft (CTA)
  • Vascularized Composite Allotransplantation (VCA)
  • Amputation
  • Upper Limb
  • Immunosuppression

Additional Relevant MeSH Terms

  • Amputation, Traumatic
  • Wounds and Injury
  • Hand Injuries