Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

∙ Diagnosis of cancer, a premalignant/neoplastic condition or disease (such as an immunodeficiency) that increases the risk of being diagnosed with a cancer or premalignant/neoplastic condition

‣ Age \>=18 years of age

‣ ECOG performance status of 0-3.

• 5\. Ability and willingness of subject to provide informed consent

• Additional inclusion criteria pertinent only for participants undergoing apheresis

⁃ Hemoglobin \>= 8 mg/dL and platelet count \> 75 K/microL

⁃ Weight \>= 48 kg

⁃ Central line in place or adequate venous access

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Scott M Norberg, D.O.
scott.norberg@nih.gov
(301) 275-9668
Time Frame
Start Date: 2016-04-11
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 500
Treatments
1/Cohort 1
Patients with cancer or a premalignant condition or at risk of cancer from an immunodeficiency
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov