NCT05995821Recruiting
Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1250 (estimated)
- First submitted
- 9 Aug 2023
- Start date
- 25 Aug 2016
- Primary completion date
- 25 Aug 2028
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Head and neck cancer, Lung cancer
- NCT number
- NCT05995821
What you commit to
- Study type: Observational
- Planned participants: 1250
- From 25 Aug 2016 to the primary completion date, 25 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- 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
Other
- Unable or unwilling to read English and complete forms/questionnaires
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.