Biological Specimen Collection for Head and Neck Cancers

Overseen By Patrick Forde, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Anemia, Bleeding disorders, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different cancer treatments affect the immune system and to find ways to improve future therapies. Researchers seek to collect samples, such as blood and tumor tissue, from individuals with cancers of the head, neck, and upper digestive tract who are receiving treatments that might impact the immune system. The trial seeks participants diagnosed with or suspected to have these types of cancer and who might undergo such treatments. Participants will help researchers learn more about treatment side effects and treatment efficacy. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for participants?

Research shows that the "Biological Specimen Collection for Head and Neck Cancers" trial focuses on collecting and studying blood and tissue samples to understand how cancer treatments affect the immune system. The study does not test new drugs or treatments. Instead, it examines how existing treatments, known or believed to impact the immune system, function.

Since the trial involves sample collection rather than testing new drugs, it presents no direct safety concerns. The treatments under study have already demonstrated some safety in humans, as they are known or thought to affect the immune system in cancer patients. Therefore, the trial emphasizes observation and analysis without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's diving into the potential of immunobiology in treating cancers of the head, neck, thorax, and upper GI tract. Unlike traditional treatments like surgery, radiation, or chemotherapy, which target the cancer directly, this approach is looking at how the immune system can be harnessed or modulated to fight the tumor. The aim is to understand how certain treatments can trigger the body's own defenses against cancer, potentially leading to more targeted and less toxic therapy options. This could open the door to personalized cancer treatment strategies that are more effective and have fewer side effects.

Who Is on the Research Team?

Joseph Murray, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Inclusion Criteria

You have a confirmed or suspected upper aerodigestive malignancy that may be treatable with immunomodulators.

You have the capacity to comprehend and agree to sign a legally binding informed consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Participants donate various biological specimens such as tumor, blood, lymph nodes, and other tissue samples.

Ongoing throughout the study

Data Collection

Demographic and clinical data are obtained via chart review and surveys to assess risk factors for immune-related adverse events.

10 years

Follow-up

Participants are monitored for immune-related adverse events and other clinical outcomes.

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Immunobiology Blood and Tissue Collection

How Is the Trial Designed?

Group I: Upper Aerodigestive Malignancies Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Stand Up To Cancer

Collaborator

Trials

53

Recruited

40,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05995821

Immunobiology Blood and Tissue Collection of Upper ... This research is being done to collect and store biological specimens (biospecimens) from people with cancer, regardless of tumor type, who are receiving ...

2. trialx.com trialx.com/clinical-trials/listings/270534/immunobiology-blood-and-tissue-collection-of-upper-aerodigestive-malignancies/

Immunobiology Blood and Tissue Collection of Upper ... This research is being done to collect and store biological specimens (biospecimens) from people with cancer, regardless of tumor type, who are ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/534156

Immunobiology Blood and Tissue Collection of Upper ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6629629/

Clinical update on head and neck cancer: molecular biology ... Head and neck squamous cell carcinomas (HNSCCs) are the sixth most common malignancy worldwide, accounting for over 500,000 new cases annually.

5. ancora.ai ancora.ai/it/details/NCT05995821

Immunobiology Blood and Tissue Collection of Upper ... 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 ...