Recruiting

NCT Number: NCT02682667

Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols

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.

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Recruiting

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Non-small Cell Lung Cancer Paraproteinemias Precancerous Conditions Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Vascular Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location status: Recruiting

About this study

Background:

-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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

INCLUSION CRITERIA:

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

Additional inclusion criteria pertinent only for participants undergoing apheresis

Hemoglobin >= 8 mg/dL and platelet count > 75 K/microL
Weight >= 48 kg
Central line in place or adequate venous access

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Sample Acquisition

Time frame: Ongoing

Biospecimen collection for study and understanding of disease.

Secondary outcomes

Associations between clinical parameters, biospecimen characteristics and patient demographics

Time frame: Ongoing

Correlation of these characteristics with disease.

Study contacts

Contact information is provided by the study sponsor or research team.

Scott M Norberg, D.O.

CONTACT

[email protected]

(301) 275-9668

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Important dates

Study start: 2016
Primary completion: 2030
Study completion: 2032
First posted: Feb 15, 2016
Registry last updated: Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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