NCT05995821 Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies
| NCT ID | NCT05995821 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Condition | Head and Neck Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,250 participants |
| Start Date | 2016-08-25 |
| Primary Completion | 2026-08-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,250 participants in total. It began in 2016-08-25 with a primary completion date of 2026-08-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Valsamo Anagnostou, MD, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT05995821 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05995821 currently recruiting?
Yes, NCT05995821 is actively recruiting participants. Contact the research team at ThoracicCancerTrials@jhmi.edu for enrollment information.
Where is the NCT05995821 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05995821 clinical trial?
NCT05995821 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The principal investigator is Valsamo Anagnostou, MD, PhD at Johns Hopkins University. The trial plans to enroll 1,250 participants.
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