Trial Title:
Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies
NCT ID:
NCT05995821
Condition:
Head and Neck Cancer
Lung Cancer
Gastrointestinal Cancer
Conditions: Official terms:
Neoplasms
Gastrointestinal Neoplasms
Conditions: Keywords:
Upper Aerodigestive Malignancies
Upper Gastrointestinal (GI) Tract
Thorax
Immunobiology
Immunomodulatory
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Collection of biological specimens
Description:
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.
Arm group label:
Upper Aerodigestive Malignancies
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.
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:
1. 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.
2. Define new tumor antigens and the tumor antigens' relevance to disease biology, and
correlate antigen expression with immune responses and disease outcomes.
3. Evaluate potential immune-related prognostic or treatment response indicators.
4. 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.
5. Investigate the immunobiology of neoadjuvant and adjuvant cancer therapies,
including but not limited to cancer vaccines.
6. Develop protein-, RNA-, and DNA-based blood markers to monitor tumor burden and
predict and detect tumor relapse.
7. Evaluate the causative mechanisms of immune-related toxicities in patients receiving
cancer therapy with immune checkpoint blockade.
8. Characterize factors and molecular pathways in the tumor immune microenvironment
that lead to immune suppression, tolerance to tumor antigens, and cancer
progression.
9. Understand the epidemiology of and risk factors for particular immune related
adverse events (irAEs) including inflammatory arthritis, sicca syndrome and myositis
10. 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.
11. 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.
12. 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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Johns Hopkins University
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Patrick Forde, MD
Phone:
410-955-3974
Email:
pforde1@jhmi.edu
Contact backup:
Last name:
Peggy Fitzpatrick, RN
Phone:
410-550-5848
Email:
mfitzpa7@jhmi.edu
Start date:
August 25, 2016
Completion date:
August 25, 2026
Lead sponsor:
Agency:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency class:
Other
Collaborator:
Agency:
Stand Up To Cancer
Agency class:
Other
Source:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05995821
