Biospecimen Procurement for Genitourinary Malignancies and Experimental Transplantation and Immunology Branch Immunotherapy Protocols
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|ClinicalTrials.gov Identifier: NCT02682667|
Recruitment Status : Recruiting
First Posted : February 15, 2016
Last Update Posted : October 8, 2020
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.
To better understand the biology of malignancies and why certain cancers respond differently to treatment.
Adults at least 18 years old with cancer or a pre-cancerous condition.
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.
|Condition or disease|
|Multiple Myeloma Lymphoma, Non-Hodgkin Leukemia-Lymphoma, Adult T-Cell Hodgkin Disease Non-Small Cell Lung Cancer|
-Immunotherapy is a promising approach to the treatment of cancer. GMB/ETIB investigators are studying immunotherapy for the treatment of diverse malignant and premalignant conditions. These studies require the collection of biospecimens for research purposes.
- 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 GMB/ETIB immunotherapy clinical trial protocols.
- To conduct nucleic acid, protein, and immunological and biological research studies on samples collected.
-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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Biospecimen Procurement for Genitourinary Malignancies and Experimental Transplantation and Immunology Branch Immunotherapy Protocols|
|Actual Study Start Date :||April 11, 2016|
|Estimated Primary Completion Date :||December 1, 2025|
|Estimated Study Completion Date :||December 1, 2027|
Patients with cancer or a premalignant condition or at risk of cancer from an immunodeficiency.
- Sample Acquisition [ Time Frame: Ongoing ]Biospecimen collection for study and understanding of disease.
- Associations between clinical parameters, biospecimen characteristics and patient demographics [ Time Frame: Ongoing ]Correlation of these characteristics with disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682667
|Contact: Erin W Ferraro, R.N.||(833) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Christian S Hinrichs, M.D.||National Cancer Institute (NCI)|