Biology Study for Neuroblastoma

Recruiting at 14 trial locations

Overseen By Araz Marachelian, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: New Approaches to Neuroblastoma Therapy Consortium

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

Compensation: Varies

Number of Visits: 1

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks better treatments for neuroblastoma, a cancer that often affects children, and aims to prevent its recurrence. Researchers will study tumor tissue, blood, and bone marrow samples to understand how neuroblastoma cells grow and respond to treatment. Individuals diagnosed with high-risk neuroblastoma, whether persistent or recurrent, may qualify for this trial. This includes those with confirmed neuroblastoma undergoing disease evaluation. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking therapy.

Will I have to stop taking my current medications?

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 these sample collection methods are safe?

In a previous study, researchers demonstrated that collecting blood samples is safe when proper techniques and precautions are followed. Common steps include using clean tools and wearing gloves. The World Health Organization provides clear guidelines to ensure safe blood draws, helping to prevent infections and other issues.

Research has also shown that collecting bone marrow samples is generally safe, though rare risks exist. These can include bleeding, especially in individuals with low platelet levels. Doctors typically reduce these risks by using sterile equipment.

Tissue sample collection occurs under strict ethical and safety guidelines, ensuring proper and safe collection. This type of collection is routine in research and follows best practices to protect participants.

Overall, these procedures have proven safe when performed correctly. Participants can feel confident in the care and precautions taken during these sample collections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring the biology of neuroblastoma through advanced sample analysis techniques. Unlike standard treatment options that focus on directly targeting the cancer with surgery, chemotherapy, or radiation, this study delves into collecting and analyzing blood, bone marrow, and tissue samples to understand the unique characteristics of each patient’s cancer. This approach could uncover new insights into how neuroblastoma develops and behaves, potentially leading to more personalized and effective treatment strategies in the future. By highlighting the individual differences in tumors, this study aims to pave the way for breakthroughs in customized therapies, making treatment more precise and potentially more effective.

Who Is on the Research Team?

Shahab Asgharzadeh, MD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients must be greater than or 31 days of age.

Patients must have had a diagnosis of high risk neuroblastoma either by histological verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines.

All patients with refractory or recurrent high risk neuroblastoma at NANT institutions are eligible regardless of disease status (including no measurable or evaluable tumor) as long as they undergo a disease evaluation and appropriate samples are submitted.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Collection of blood, bone marrow, and/or tumor samples for storage and research

1-2 weeks

1 visit (in-person)

Data Collection

Collection of clinical data and radiology scans for laboratory studies

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after sample collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Blood Sample Collection
• Bone Marrow Sample Collection
• Tissue Sample Collection

Who Is Running the Clinical Trial?

New Approaches to Neuroblastoma Therapy Consortium

Lead Sponsor

Trials

19

Recruited

1,700+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK574569/

Phlebotomy - StatPearls - NCBI Bookshelf The basic tools required for a successful and safe blood draw include a tourniquet, an appropriate needle, gloves, alcohol wipes, and the ...

2. who.int who.int/publications/i/item/9789241599221

WHO guidelines on drawing blood: best practices in ... The new WHO guidelines provide recommended steps for safe phlebotomy and reiterate accepted principles for drawing, collecting blood and transporting blood.

3. cdc.gov cdc.gov/dpdx/diagnosticprocedures/blood/safety.html

DPDx - Diagnostic Procedures - Blood Specimens Blood Specimens – Safety · Wear personal protective equipment such as safety glasses, gloves, laboratory coats. · If you have cuts or abrasions on the skin of ...

4. elsevier.health elsevier.health/en-US/preview/india-blood-specimen-venipuncture-vacuum

Blood Specimen Collection: Venipuncture Vacuum ... Venipuncture requires an aseptic no-touch technique and sterile gloves if contact with the skin is required after the skin preparation with an ...

5. aob.amegroups.org aob.amegroups.org/article/view/4318/5055

Labeling tubes before collection threatens patient safety - Ernst Blood specimen identification errors continue to threaten patient safety. One study reviewed 4.29 million specimens collected over 24 months and found the ...