Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols

Multiple Myeloma Clinical Trial

Official title:

Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02682667
• Other study ID #: 160061
• Secondary ID: 16-C-0061
• Status: Recruiting
• Start date: April 11, 2016
• Est. completion date: December 1, 2027

Study information

• Verified date: June 3, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Scott M Norberg, D.O.
• Phone: (301) 275-9668
• Email: scott.norberg[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background:

Cancer has a major impact in the United States and across the world. In 2015, over 1.5 million new cases of cancer were diagnosed in the U.S. Researchers want to study samples from people with cancer or a pre-malignant condition. They hope to develop more effective treatments.

Objective:

To better understand the biology of malignancies and why certain cancers respond differently to treatment.

Eligibility:

Adults at least 18 years old with cancer or a pre-cancerous condition.

Design:

Participants will be screened with a medical history, physical exam, and blood tests. Their diagnosis will be confirmed by the NCI Laboratory of Pathology.

Participants will send tissue blocks or slides from their original tumor biopsy.

At least once, participants will have a medical history, physical exam, and blood and urine tests.

Participants may have the following tests. They may have them more than once:

Apheresis. A needle in one arm removes blood. Blood is run through a machine and the sample cells are taken out. The rest of the blood is returned by a needle in the other arm.

Bone marrow aspiration and biopsy. The hipbone will be numbed. A needle will be put into the hipbone. Bone marrow will be taken out through the needle.

Piece of cancer tissue taken by a needle and syringe.

Computed tomography (CT) scan, magnetic resonance imaging (MRI) and/or positron emission tomography (PET) scan or ultrasound to help locate their tumor. For the scans, they lie in a machine that takes pictures.

A small piece of skin removed.

Participants will be contacted by phone once a year to find out how they are doing.

...

Description:

Background:

-Immunotherapy is a promising approach to the treatment of cancer. CIO investigators are studying immunotherapy for the treatment of diverse malignant and premalignant conditions. These studies require the collection of biospecimens for research purposes.

Objectives:

• To collect and bank blood, apheresis products, tumor, body fluids, and other biospecimens from patients with cancer or a premalignant disease or at risk of cancer from an immunodeficiency.

• To collect and bank biospecimens as directed by companion CIO immunotherapy clinical trial protocols.

• To conduct nucleic acid, protein, and immunological and biological research studies on samples collected.

Eligibility:

-Patients must be 18 years of age or older with a diagnosis of cancer or a premalignant condition or an immunodeficiency that increases the risk of being diagnosed with a cancer or premalignant condition.

Design:

• Up to 500 subjects will be enrolled.

• Patients will undergo sampling of blood, apheresis products, tumor, effusions, ascites, urine, bone marrow, serum, plasma, skin, mucosa, or other tissues for banking and laboratory studies.

• No investigational or experimental therapy will be given as part of this protocol.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2027
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

• INCLUSION CRITERIA:

1. Diagnosis of cancer, a premalignant condition or an immunodeficiency that increases the risk of being diagnosed with a cancer or premalignant condition

2. Age >=18 years of age

3. ECOG performance status of 0-3.

5. Ability and willingness of subject to provide informed consent

Additional inclusion criteria pertinent only for patients undergoing apheresis

1. Hemoglobin >= 8 mg/dL and platelet count > 75 K/uL

2. Weight >= 48 kg

3. Central line in place or adequate venous access

EXCLUSION CRITERIA:

1. Active concomitant medical or psychological illnesses that may increase the risk to the subject.

2. Inability to provide informed consent

3. Pregnant or breastfeeding women (not applicable to patients enrolled only for collection of tissue and blood from outside sources)

Related Conditions & MeSH terms

• Hodgkin Disease
• Leukemia-Lymphoma, Adult T-Cell
• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sample Acquisition	Biospecimen collection for study and understanding of disease.	Ongoing
Secondary	Associations between clinical parameters, biospecimen characteristics and patient demographics	Correlation of these characteristics with disease.	Ongoing

External Links

•   NIH Clinical Center Detailed Web Page