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Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02682667
Recruitment Status : Recruiting
First Posted : February 15, 2016
Last Update Posted : July 14, 2022
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


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

Detailed Description:


-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.


  • 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.


-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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Actual Study Start Date : April 11, 2016
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : December 1, 2027

1/Cohort 1
Patients with cancer or a premalignant condition or at risk of cancer from an immunodeficiency

Primary Outcome Measures :
  1. Sample Acquisition [ Time Frame: Ongoing ]
    Biospecimen collection for study and understanding of disease.

Secondary Outcome Measures :
  1. Associations between clinical parameters, biospecimen characteristics and patient demographics [ Time Frame: Ongoing ]
    Correlation of these characteristics with disease.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be any person over the age of 18 with a diagnosis of cancer or a premalignant disease. Participants are selected from other NIH protocols (including screening protocols) they may be co-enrolled on and can include both inpatient and outpatient.

    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


  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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT02682667

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Contact: Erin W Ferraro, R.N. (240) 760-6163
Contact: Scott M Norberg, D.O. (301) 275-9668

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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      
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Scott M Norberg, D.O. National Cancer Institute (NCI)
Additional Information:
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT02682667    
Other Study ID Numbers: 160061
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: July 14, 2022
Last Verified: July 8, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Clinical data available during the study and indefinitely.@@@@@@Genomic data will be shared from the time of upload to dbGaP.
Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@Genomic IPD will be shared through dbGaP, per rules of the database, for purposes of genomic analysis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Apheresis Products
Diverse Malignan
Natural History
Additional relevant MeSH terms:
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Multiple Myeloma
Hodgkin Disease
Lymphoma, Non-Hodgkin
Leukemia-Lymphoma, Adult T-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Leukemia, T-Cell
Leukemia, Lymphoid