NCT05995821 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies
What this study is about
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.
View original scientific 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.
Interventions
OTHER
Collection of biological specimens
Collection 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.
Primary outcome measures
Demographic and clinical data obtained via chart review
Time frame: 10 years
This is a clinic based registry of cancer therapy data from participants to be collected over time.
Biological specimens obtained from cancer patients
Time frame: 10 years
This is a virtual tissue bank containing biological specimens from participants collected over time.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Baltimore, Maryland
Collaborators
Stand Up To Cancer
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 29, 2026 · Source of record for eligibility and locations