Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects with a pathologically confirmed or clinically suspected upper aerodigestive malignancy who may be candidates for known or potentially immunomodulating treatments
Ability to understand and willingness to sign a written informed consent document
Disqualifiers
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
Patients with known significant contraindications for biopsy (e.g., severe bleeding diathesis) will be excluded from the tissue biopsy component of the study
Patients with known significant contraindications for bronchoscopy (e.g., airway concerns, significant cardiac disease) will be excluded from the bronchoscopy component of the study
Unable or unwilling to read English and complete forms/questionnaires
Trial population
Both men and women and members of all races and ethnic groups are eligible for participation in this tissue and blood collection protocol. An unlimited number of subjects may be accrued to this study at the Johns Hopkins University. Potential research subjects will be identified by their primary physician/clinical team. The research subjects will be patients with cancer of the head and neck, thorax and upper gastrointestinal tract, who are receiving or may receive treatments known or hypothesized to have an immunomodulatory antitumor effect. The immunologic studies will be conducted across tumor types and treatment modalities.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Collection of biological specimens
Other interventionCollection of tumor, blood, lymph nodes, white blood cells, mouth cells (buccal smears) scraped from the inside of your cheek, urine, saliva, or other tissue samples.
Treatment groups
1,250 Participants
are divided into 1 treatment groupGroup A: Upper Aerodigestive Malignancies1 intervention
Trial outcomes
Primary outcomes
1
Demographic and clinical data obtained via chart review
This is a clinic based registry of cancer therapy data from participants to be collected over time.
Time frame
10 years2
Biological specimens obtained from cancer patients
This is a virtual tissue bank containing biological specimens from participants collected over time.
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Stand Up To Cancer
Collaborator
Source ClinicalTrials.gov