Biospecimen Procurement for Experimental Transplantation and Immunology Branch Immunotherapy Protocols
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer, Blood Cancer, Blood Cancer, Lymphoma, Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 3/23/2019 |
| Start Date: | April 11, 2016 |
| End Date: | December 1, 2027 |
| Contact: | Erin W Ferraro, R.N. |
| Email: | erin.ferraro@nih.gov |
| Phone: | (833) 815-0387 |
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.
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.
Background:
-Immunotherapy is a promising approach to the treatment of cancer. ETIB 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.
- To collect and bank biospecimens as directed by companion ETIB 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.
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.
-Immunotherapy is a promising approach to the treatment of cancer. ETIB 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.
- To collect and bank biospecimens as directed by companion ETIB 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.
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.
- INCLUSION CRITERIA:
1. Diagnosis of cancer or a premalignant condition
2. Age greater than or equal to 18 years of age
3. ECOG performance status of 0-3
4. Ability and willingness of subject to provide informed consent
INCLUSION FOR APHERESIS:
1. Hemoglobin greater than or equal to 8 mg/dL and platelet count > 75 K/uLuL
2. Weight greater than or equal to 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 obtain informed consent
3. Pregnant or breast feeding women
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 888-624-1937
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