RECRUITING

Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies

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

This research is being done to collect and store biological specimens (biospecimens) from people with cancer, regardless of tumor type, who are receiving treatments known or thought to have an effect on the immune system. The goal of this discovery and exploratory study is to: * Understand changes in the immune system associated with various cancer treatments, in order to better design new therapies or tests to predict how these treatments might work. * Identify risk factors for those who go on to develop side effects from immunotherapy. * Identify the molecular features associated with response and resistance to cancer therapies and immunotherapy using integrative genomic and immune repertoire characterization. * Capture and characterize systemic tumor burden by minimally invasive analyses of circulating tumor DNA. Participants may be asked to: * Donate samples of tumor, blood, lymph nodes, white blood cells, mouth cells (buccal smears) scraped from the inside of participant's cheek, urine, saliva, or other tissue samples. * Complete questionnaires about immunotherapy side effects at baseline and with follow-up appointments. * Undergo knee x-rays. * Allow the use of demographic and clinical information.

Official Title

Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies

Quick Facts

Study Start:2016-08-25
Study Completion:2026-08-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05995821

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. * Subjects with a pathologically confirmed or clinically suspected upper aerodigestive malignancy who may be candidates for known or potentially immunomodulating treatments
  2. * Ability to understand and willingness to sign a written informed consent document
  1. * Patients with known significant contraindications for venipuncture (e.g., hemoglobin \<8.5 g/dL) will be excluded from the blood collection component of the study
  2. * Patients with known significant contraindications for biopsy (e.g., severe bleeding diathesis) will be excluded from the tissue biopsy component of the study
  3. * Patients with known significant contraindications for bronchoscopy (e.g., airway concerns, significant cardiac disease) will be excluded from the bronchoscopy component of the study
  4. * Unable or unwilling to read English and complete forms/questionnaires

Contacts and Locations

Study Contact

Patrick Forde, MD
CONTACT
410-955-3974
pforde1@jhmi.edu
Peggy Fitzpatrick, RN
CONTACT
410-550-5848
mfitzpa7@jhmi.edu

Principal Investigator

Patrick Forde, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins University
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  • Patrick Forde, MD, 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 Date2016-08-25
Study Completion Date2026-08-25

Study Record Updates

Study Start Date2016-08-25
Study Completion Date2026-08-25

Terms related to this study

Keywords Provided by Researchers

  • Upper Aerodigestive Malignancies
  • Upper Gastrointestinal (GI) Tract
  • Thorax
  • Immunobiology
  • Immunomodulatory

Additional Relevant MeSH Terms

  • Head and Neck Cancer
  • Lung Cancer
  • Gastrointestinal Cancer