Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies (NCT05995821) | Clinical Trial Compass
RecruitingNot Applicable
Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies
United States1,250 participantsStarted 2016-08-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Demographic and clinical data obtained via chart review
Timeframe: 10 years
2
Biological specimens obtained from cancer patients
Timeframe: 10 years
Trial details
NCT IDNCT05995821
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins