Protocol Details
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
This study is currently recruiting participants.
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.
Eligibility
INCLUSION CRITERIA: 1. 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
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 participants undergoing apheresis
1. Hemoglobin >= 8 mg/dL and platelet count > 75 K/microL
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
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT02682667