Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies

NCT05995821 | Recruiting

• 2 other identifiers: J1655IRB00100653
• Study Type: observational
• Target: 1,250
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Lung Cancer; Gastrointestinal Cancer

Keywords

Upper Aerodigestive Malignancies; Upper Gastrointestinal (GI) Tract; Thorax; Immunobiology; Immunomodulatory

Outcome Measures

Primary Outcomes (2)

• 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.

  10 years

• Biological specimens obtained from cancer patients

  This is a virtual tissue bank containing biological specimens from participants collected over time.

  10 years

Study Arms (1)

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.

Other: Collection of biological specimens

Interventions

Collection of biological specimens OTHER

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.

Upper Aerodigestive Malignancies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Stand Up To Cancer: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Tissue Sample Acquisition: * Excess material collected in the course of therapeutic procedures that are clinically indicated; or * New biopsies performed for research purposes (e.g., a palpable subcutaneous nodule, or a lymph node that is accessible by ultrasound or computed tomography scan guidance under local anesthesia). * Blood Sample Acquisition: A peripheral blood sample will be collected from each participating subject for the isolation and cryopreservation of viable peripheral blood mononuclear cells, serum, and plasma. * Leukapheresis: patients may undergo pheresis for the purpose of collecting large numbers of leukocytes for research purposes. * Buccal smears * Bronchoscopy: Endobronchial brushings +/- biopsies * Nasal Epithelium Collection * Expectorated Sputum Collection

MeSH Terms

Conditions

Head and Neck Neoplasms; Lung Neoplasms; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Valsamo Anagnostou, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Joseph Murray, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valsamo Anagnostou, MD, PhD

CONTACT

410-614-8948; ThoracicCancerTrials@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: August 25, 2016
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): August 25, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)