RecruitingNCT02682667

Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols


Sponsor

National Cancer Institute (NCI)

Enrollment

500 participants

Start Date

Apr 11, 2016

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 120 Years

Inclusion Criteria7

  • 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.
  • \. Ability and willingness of subject to provide informed consent
  • Hemoglobin \>= 8 mg/dL and platelet count \> 75 K/microL
  • Weight \>= 48 kg
  • Central line in place or adequate venous access

Exclusion Criteria3

  • Active concomitant medical or psychological illnesses that may increase the risk to the subject.
  • Inability to provide informed consent
  • Pregnant or breastfeeding women

Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT02682667


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