Ignite Creation Date:
2024-05-06 @ 8:11 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02682667
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2016-02-10
Brief Title:
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Status:
RECRUITING
Status Verified Date:
2024-09-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Cancer has a major impact in the United States and across the world In 2015 over 15 million new cases of cancer were diagnosed in the US 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 andor 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 15 million new cases of cancer were diagnosed in the US 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 andor 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
-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 16-C-0061 | None | None | None |