Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
NCT ID: NCT02682667
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
500 participants
OBSERVATIONAL
2016-04-11
2032-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
-Immunotherapy is a promising approach to the treatment of cancer. CIO investigators are studying immunotherapy for the treatment of diverse malignant and premalignant conditions. These studies require the collection of biospecimens for research purposes.
Objectives:
* To collect and bank blood, apheresis products, tumor, body fluids, and other biospecimens from patients with cancer or a premalignant disease or at risk of cancer from an immunodeficiency.
* To collect and bank biospecimens as directed by companion CIO immunotherapy clinical trial protocols.
* To conduct nucleic acid, protein, and immunological and biological research studies on samples collected.
Eligibility:
-Patients must be 18 years of age or older with a diagnosis of cancer or a premalignant condition or an immunodeficiency that increases the risk of being diagnosed with a cancer or premalignant condition.
Design:
* Up to 500 subjects will be enrolled.
* Patients will undergo sampling of blood, apheresis products, tumor, effusions, ascites, urine, bone marrow, serum, plasma, skin, mucosa, or other tissues for banking and laboratory studies.
* No investigational or experimental therapy will be given as part of this protocol.
* Re-enrollment will be allowed for a small number of participants.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1/Cohort 1
Patients with cancer or a premalignant condition or at risk of cancer from an immunodeficiency
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age \>=18 years of age
3. ECOG performance status of 0-3.
5\. Ability and willingness of subject to provide informed consent
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
2. Inability to provide informed consent
3. Pregnant or breastfeeding women
18 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Scott M Norberg, D.O.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
NIH Clinical Center Detailed Web Page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
160061
Identifier Type: -
Identifier Source: org_study_id
16-C-0061
Identifier Type: -
Identifier Source: secondary_id