Recruiting

Observational Study

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT05995821

Conditions

Head and Neck Cancer

Lung Cancer

Gastrointestinal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Collection of biological specimens

Study Details

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

Study ID

NCT05995821

Start date

Aug 25, 2016

Status verified date

Aug, 2026

Completion date

Aug 25, 2028

Anticipated

Primary completion date

Aug 25, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1250 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Collection of biological specimens

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.

Primary outcome measure

  • Demographic and clinical data obtained via chart review [ Time Frame: 10 years ]
  • Biological specimens obtained from cancer patients [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Valsamo Anagnostou, MD, PhD

410-614-8948ThoracicCancerTrials@jhmi.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Valsamo Anagnostou, MD, PhD

410-614-8948ThoracicCancerTrials@jhmi.edu

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-08-06.