Head and Neck CancerNCT05995821
Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies
An observational study of Head and Neck Cancer and Lung Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Lung Cancer, Gastrointestinal Cancer
- What is being tested?
- Collection of biological specimens
- How many people
- 1,250 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2016to 25 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Valsamo Anagnostou, MD, PhD, 410-614-8948, ThoracicCancerTrials@jhmi.edu
About this study
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:
Read more
- 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.
Read the detailed description
The Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies Protocol is a discovery and exploratory protocol that will enable the investigators to obtain and archive biological specimens from 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 investigators aim to conduct immunologic studies across tumor types and treatment modalities in order to accomplish the following:
- Gain mechanistic insights into the potential influence of various forms of cancer therapy on antitumor immunity, including but not limited to chemotherapies, kinase inhibitors, angiogenesis inhibitors, immune-modulating monoclonal antibodies, cellular immune therapies and radiation therapy.
- Define new tumor antigens and the tumor antigens' relevance to disease biology, and correlate antigen expression with immune responses and disease outcomes.
- Evaluate potential immune-related prognostic or treatment response indicators.
- Assess the immunologic features of pre-malignant lesions (e.g., atypical or dysplastic nevi, dysplastic bronchial epithelium, colonic adenomas), and compare these features to features of invasive cancers.
- Investigate the immunobiology of neoadjuvant and adjuvant cancer therapies, including but not limited to cancer vaccines.
- Develop protein-, RNA-, and DNA-based blood markers to monitor tumor burden and predict and detect tumor relapse.
- Evaluate the causative mechanisms of immune-related toxicities in patients receiving cancer therapy with immune checkpoint blockade.
- Characterize factors and molecular pathways in the tumor immune microenvironment that lead to immune suppression, tolerance to tumor antigens, and cancer progression.
- Understand the epidemiology of and risk factors for particular immune related adverse events (irAEs) including inflammatory arthritis, sicca syndrome and myositis
- Perform integrative genomic, transcriptomic and immune repertoire characterization of cancers with differential responses to immunotherapy and cancer therapies to determine the molecular features of responding and resistant tumors.
- Study clonal evolution through genomic, neoantigen, transcriptomic, spatial transcriptomic, and immune repertoire analyses in order to map the evolutionary trajectories of cancer and immune cells under selective pressure of cancer therapies including immune checkpoint blockade.
- Employ non-invasive molecular assays and analyses of circulating cell-free tumor DNA to capture peripheral tumor and immune compartment dynamics as they relate to response to cancer therapies including immunotherapy.
To support the above research aims, biological specimens obtained and processed in the individual laboratories of the co-investigators will be linked by a centralized demographic database, allowing for the retrieval of information regarding specimen characteristics (e.g., tumor type, treatment exposure, date of specimen retrieval, anatomic site of biopsy, biopsy procedure) and clinical outcomes. Participants starting on immune checkpoint inhibitors will complete a survey when the participants enroll on study to assess for potential risk factors for irAE development. Participants will also undergo knee radiographs to evaluate for osteoarthritis, baseline survey for personal and family historical risk factors, and serial surveys designed to screen for development of irAEs This information will be correlated with the results of exploratory scientific analyses conducted in the laboratories of the co-investigators. Hypotheses generated from this work are expected to support future hypothesis-driven scientific investigations and clinical trial development.
- Conditions
- Head and Neck Cancer, Lung Cancer, Gastrointestinal Cancer
- Being tested
- Collection of biological specimens
- Keywords
- Upper Aerodigestive Malignancies, Upper Gastrointestinal (GI) Tract, Thorax, Immunobiology, Immunomodulatory
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of biological specimensOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Upper Aerodigestive Malignancies | 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. Receives: Other: Collection of biological specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Biological specimens obtained from cancer patients
This is a virtual tissue bank containing biological specimens from participants collected over time.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start25 Aug 2016
- Primary completion25 Aug 2028 (estimated)
- Study completion25 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Stand Up To Cancer
- Responsible party
- Sponsor
- Investigators
- Valsamo Anagnostou, MD, PhD, Principal investigator, Johns Hopkins UniversityJoseph Murray, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995821
- Sponsor's protocol ID
- J1655
- Other IDs
- IRB00100653
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies
- ClinicalTrials.gov ID
- NCT05995821
- Acronym / sponsor ID
- J1655
- Conditions
- Head and Neck Cancer, Lung Cancer, Gastrointestinal Cancer
- Keywords
- Upper Aerodigestive Malignancies, Upper Gastrointestinal (GI) Tract, Thorax, Immunobiology, Immunomodulatory
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Stand Up To Cancer
- Study start
- 25 Aug 2016 (actual)
- Primary completion
- 25 Aug 2028 (estimated)
- Study completion
- 25 Aug 2028 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies Protocol is a discovery and exploratory protocol that will enable the investigators to obtain and archive biological specimens from 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 investigators aim to conduct immunologic studies across tumor types and treatment modalities in order to accomplish the following:
- Gain mechanistic insights into the potential influence of various forms of cancer therapy on antitumor immunity, including but not limited to chemotherapies, kinase inhibitors, angiogenesis inhibitors, immune-modulating monoclonal antibodies, cellular immune therapies and radiation therapy.
- Define new tumor antigens and the tumor antigens' relevance to disease biology, and correlate antigen expression with immune responses and disease outcomes.
- Evaluate potential immune-related prognostic or treatment response indicators.
- Assess the immunologic features of pre-malignant lesions (e.g., atypical or dysplastic nevi, dysplastic bronchial epithelium, colonic adenomas), and compare these features to features of invasive cancers.
- Investigate the immunobiology of neoadjuvant and adjuvant cancer therapies, including but not limited to cancer vaccines.
- Develop protein-, RNA-, and DNA-based blood markers to monitor tumor burden and predict and detect tumor relapse.
- Evaluate the causative mechanisms of immune-related toxicities in patients receiving cancer therapy with immune checkpoint blockade.
- Characterize factors and molecular pathways in the tumor immune microenvironment that lead to immune suppression, tolerance to tumor antigens, and cancer progression.
- Understand the epidemiology of and risk factors for particular immune related adverse events (irAEs) including inflammatory arthritis, sicca syndrome and myositis
- Perform integrative genomic, transcriptomic and immune repertoire characterization of cancers with differential responses to immunotherapy and cancer therapies to determine the molecular features of responding and resistant tumors.
- Study clonal evolution through genomic, neoantigen, transcriptomic, spatial transcriptomic, and immune repertoire analyses in order to map the evolutionary trajectories of cancer and immune cells under selective pressure of cancer therapies including immune checkpoint blockade.
- Employ non-invasive molecular assays and analyses of circulating cell-free tumor DNA to capture peripheral tumor and immune compartment dynamics as they relate to response to cancer therapies including immunotherapy.
To support the above research aims, biological specimens obtained and processed in the individual laboratories of the co-investigators will be linked by a centralized demographic database, allowing for the retrieval of information regarding specimen characteristics (e.g., tumor type, treatment exposure, date of specimen retrieval, anatomic site of biopsy, biopsy procedure) and clinical outcomes. Participants starting on immune checkpoint inhibitors will complete a survey when the participants enroll on study to assess for potential risk factors for irAE development. Participants will also undergo knee radiographs to evaluate for osteoarthritis, baseline survey for personal and family historical risk factors, and serial surveys designed to screen for development of irAEs This information will be correlated with the results of exploratory scientific analyses conducted in the laboratories of the co-investigators. Hypotheses generated from this work are expected to support future hypothesis-driven scientific investigations and clinical trial development.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upper Aerodigestive Malignancies | – | Other: Collection of biological specimensPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of biological specimensCollection 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. | Other | Upper Aerodigestive Malignancies |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valsamo Anagnostou, MD, PhD principal investigator
Johns Hopkins University
Joseph Murray, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Lung Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valsamo Anagnostou, MD, PhD (410-614-8948, ThoracicCancerTrials@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic and clinical data obtained via chart review (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.