RECRUITING

Neurofibromatosis Type 1 Tumor Early Detection Study

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

The goal of this observational study is to determine if a liquid biopsy (i.e. blood test) is an effective clinical tool for monitoring the development of malignant peripheral nerve sheath tumor (MPNST) among adults (18 years and older) with Neurofibromatosis Type 1 (NF1), compared to the current standard of care. The main questions it aims to answer are: How effective is liquid biopsy compared to the current standard of care (clinical surveillance and imaging) for early detection of MPNST development among people with NF1? Can liquid biopsy offer a cost-effective method for early detection of MPNST in people with NF1? Also, can liquid biopsy provide earlier detection that potentially leads to better outcomes? Also, can offering liquid biopsy improve access to care for people experiencing barriers to access (such as minority populations or people in rural areas)? At baseline, participants will be asked to: * Complete surveys to provide their demographic and NF1-related health information. * Report whether or not they are experiencing MPNST-related symptoms. * Provide blood samples (15 mL blood total between three tubes, which is approximately one tablespoon). Every six months during the five-year follow-up period, participants will be asked to: * Complete additional surveys to report whether or not they are experiencing MPNST-related symptoms and/or if they have been diagnosed with a new MPNST. * Provide an additional blood sample (10 mL blood total in one tube). If diagnosed with an MPNST by their healthcare provider during the follow-up period, participants will be asked to: * Complete an additional survey regarding their diagnosis and symptoms. * Provide an additional blood sample (10 mL blood in one tube). * In parallel, the study team will request a sample of tumor tissue from the care provider, if available.

Official Title

Observational Trial of Liquid Biopsy for Malignant Peripheral Nerve Sheath Tumor (MPNST) Among Participants With Neurofibromatosis Type 1

Quick Facts

Study Start:2024-08-07
Study Completion:2030-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06515860

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:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years and older (adults only)
  2. * Neurofibromatosis Type 1 (NF1) diagnosis (2021 Revised Diagnostic Criteria, PMID: 34012067)
  3. * History of plexiform neurofibroma (PN)
  4. * Able to read and understand English or Spanish
  5. * Live in the USA
  1. * Are children (younger than 18 years old)
  2. * Do not have NF1
  3. * Have no evidence of PN
  4. * Are not able to read and understand English or Spanish

Contacts and Locations

Study Contact

David T Miller, MD, PhD
CONTACT
617-355-8221
david.miller2@childrens.harvard.edu
Aryani Pallerla, BS
CONTACT
6173554517
aryani.pallerla@childrens.harvard.edu

Principal Investigator

David T Miller, MD, PhD
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital

Study Locations (Sites)

Boston Children's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: David Miller

  • David T Miller, MD, PhD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

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 Date2024-08-07
Study Completion Date2030-07

Study Record Updates

Study Start Date2024-08-07
Study Completion Date2030-07

Terms related to this study

Keywords Provided by Researchers

  • Liquid biopsy
  • Cancer surveillance
  • Tumor early detection

Additional Relevant MeSH Terms

  • Neurofibromatosis Type 1
  • Neurofibromatosis 1
  • Plexiform Neurofibroma
  • Plexiform Neurofibromas
  • Malignant Peripheral Nerve Sheath Tumor
  • Malignant Peripheral Nerve Sheath Tumors
  • Atypical Neurofibroma