Clinical trial NCT02682667: Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Official title: Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Lymphoma, Non-Hodgkin
Leukemia-Lymphoma, Adult T-Cell
Hodgkin Disease
Non-Small Cell Lung Cancer
Keywords: Apheresis Products
Immunological
Diverse Malignan
Premalignant
Protein
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2016-02-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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. 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.

Eligibility criteria: * INCLUSION CRITERIA:

  1. 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
  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 participants undergoing apheresis

1. Hemoglobin \>= 8 mg/dL and platelet count \> 75 K/microL
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

Primary outcomes:
measure: Sample Acquisition
timeFrame: Ongoing
Secondary outcomes:
measure: Associations between clinical parameters, biospecimen characteristics and patient demographics
timeFrame: Ongoing
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Scott M Norberg, D.O.
role: PRINCIPAL_INVESTIGATOR
References: