Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols

NCT02682667 | Recruiting

• 2 other identifiers: 16006116-C-0061
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin; Hodgkin Disease; Non-Small Cell Lung Cancer; Leukemia-Lymphoma, Adult T-Cell

Keywords

Apheresis Products; Immunological; Diverse Malignan; Premalignant; Protein; Natural History

Outcome Measures

Primary Outcomes (1)

• Sample Acquisition

  Biospecimen collection for study and understanding of disease.

  Ongoing

Secondary Outcomes (1)

• Associations between clinical parameters, biospecimen characteristics and patient demographics

  Ongoing

Study Arms (1)

1/Cohort 1

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Age \>=18 years of age
• ECOG performance status of 0-3.
• \. Ability and willingness of subject to provide informed consent
• Hemoglobin \>= 8 mg/dL and platelet count \> 75 K/microL
• Weight \>= 48 kg
• Central line in place or adequate venous access

You may not qualify if:

• Active concomitant medical or psychological illnesses that may increase the risk to the subject.
• Inability to provide informed consent
• Pregnant or breastfeeding women

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin; Leukemia-Lymphoma, Adult T-Cell; Hodgkin Disease; Carcinoma, Non-Small-Cell Lung; Precancerous Conditions

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases; Leukemia, T-Cell; Leukemia, Lymphoid; Leukemia; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Scott M Norberg, D.O.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott M Norberg, D.O.

CONTACT

(301) 275-9668; scott.norberg@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 15, 2016
• Study Start: April 11, 2016
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2032
• Last Updated: April 29, 2026

Record last verified: 2025-11-18

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)