Biospecimen Procurement for Genitourinary Malignancies Branch Immunotherapy Protocols

Biospecimen Procurement for Genitourinary Malignancies Branch Immunotherapy Protocols


Lead Sponsor: National Cancer Institute (NCI)

Source National Institutes of Health Clinical Center (CC)
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.

Detailed Description

Background: -Immunotherapy is a promising approach to the treatment of cancer. GMB 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 GMB 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.

Overall Status Recruiting
Start Date 2016-04-11
Completion Date 2027-12-01
Primary Completion Date 2025-12-01
Study Type Observational
Primary Outcome
Measure Time Frame
Sample Acquisition Ongoing
Secondary Outcome
Measure Time Frame
Associations between clinical parameters, biospecimen characteristics and patient demographics Ongoing
Enrollment 500

Sampling Method:

Non-Probability Sample


- INCLUSION CRITERIA: 1. Diagnosis of cancer, a premalignant condition or an immunodeficiency that increases the risk of being diagnosed with a cancer or premalignant 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 patients undergoing apheresis 1. Hemoglobin >= 8 mg/dL and platelet count > 75 K/uL 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 (not applicable to patients enrolled only for collection of tissue and blood from outside sources)



Minimum Age:

18 Years

Maximum Age:


Healthy Volunteers:


Overall Official
Last Name Role Affiliation
Scott M Norberg, D.O. Principal Investigator National Cancer Institute (NCI)
Overall Contact

Last Name: Erin W Ferraro, R.N.

Phone: (240) 760-6163

Email: [email protected]

Facility: Status: Contact: National Institutes of Health Clinical Center, 9000 Rockville Pike For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937
Location Countries

United States

Verification Date


Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: 1/Cohort 1

Description: Patients with cancer or a premalignant condition or at risk of cancer from an immunodeficiency.

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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