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Protocol Details

Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

16-C-0061

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

Apheresis Products;
Immunological;
Diverse Malignan;
Premalignant;
Protein;
Natural History

Recruitment Keyword(s)

None

Condition(s)

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

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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.

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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)


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Scott M. Norberg, D.O.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N240
10 CENTER DR
BETHESDA MD 20892
(301) 275-9668
scott.norberg@nih.gov

Scott M. Norberg, D.O.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N240
10 CENTER DR
BETHESDA MD 20892
(301) 275-9668
scott.norberg@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT02682667

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