NCT02682667 Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
| NCT ID | NCT02682667 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Multiple Myeloma |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2016-04-11 |
| Primary Completion | 2030-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2016-04-11 with a primary completion date of 2030-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
* 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
Contact & Investigator
Scott M Norberg, D.O.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT02682667 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02682667 currently recruiting?
Yes, NCT02682667 is actively recruiting participants. Contact the research team at scott.norberg@nih.gov for enrollment information.
Where is the NCT02682667 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT02682667 clinical trial?
NCT02682667 is sponsored by National Cancer Institute (NCI). The principal investigator is Scott M Norberg, D.O. at National Cancer Institute (NCI). The trial plans to enroll 500 participants.