Acquisition of Blood and Tumor Tissue Samples From Patients With Gastrointestinal Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Vaccines |
| Therapuetic Areas: | Immunology / Infectious Diseases, Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 12/27/2018 |
| Start Date: | March 10, 2011 |
| Contact: | Suzanne Fioravanti, R.N. |
| Email: | fioravas@mail.nih.gov |
| Phone: | (240) 760-6113 |
Background:
- Gastrointestinal cancers can occur in the throat, stomach, gallbladder, liver, pancreas,
and colon. Researchers are interested in evaluating how active the immune system is in trying
to fight the cancer by studying blood and tumor tissue donated from individuals who have been
diagnosed with gastrointestinal cancers.
Objectives:
- To collect blood and tumor samples from individuals who have been diagnosed with
gastrointestinal cancers in order to study the immune system s response to the cancer.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with throat, stomach,
gallbladder, liver, pancreatic, or colon cancer, and are scheduled to be treated at the
National Institutes of Health.
Design:
- The study will require at least one but no more than four visits to the National
Institutes of Health Clinical Center.
- Participants will be screened with a physical examination and medical history, and will
provide a baseline blood sample for study.
- Participants will provide additional blood samples 2 and 4 months after the baseline
sample, as well as a final sample at the completion of the treatment protocol.
- Participants will provide tumor tissue samples only if they undergo a surgical procedure
related to the treatment for their gastrointestinal cancer.
- No treatment will be provided as part of this protocol.
- Gastrointestinal cancers can occur in the throat, stomach, gallbladder, liver, pancreas,
and colon. Researchers are interested in evaluating how active the immune system is in trying
to fight the cancer by studying blood and tumor tissue donated from individuals who have been
diagnosed with gastrointestinal cancers.
Objectives:
- To collect blood and tumor samples from individuals who have been diagnosed with
gastrointestinal cancers in order to study the immune system s response to the cancer.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with throat, stomach,
gallbladder, liver, pancreatic, or colon cancer, and are scheduled to be treated at the
National Institutes of Health.
Design:
- The study will require at least one but no more than four visits to the National
Institutes of Health Clinical Center.
- Participants will be screened with a physical examination and medical history, and will
provide a baseline blood sample for study.
- Participants will provide additional blood samples 2 and 4 months after the baseline
sample, as well as a final sample at the completion of the treatment protocol.
- Participants will provide tumor tissue samples only if they undergo a surgical procedure
related to the treatment for their gastrointestinal cancer.
- No treatment will be provided as part of this protocol.
BACKGROUND:
- Numerous recent therapeutic advances have changed standard treatment options for
patients with GI cancer. These include newer chemotherapeutic agents in addition to
established proof of principle for anti-angiogenic agents. The burden of GI cancers is
reflected by the presence of three GI cancer types in the top five causes of cancer
mortality. Over 58,000 deaths yearly can be attributed to GI cancer.
- While immune-based therapies in GI cancers are experimental at the current time, a
gathering body of literature is suggestive of an enormous potential, either alone, or
most likely in combination with standard chemotherapy.
- Before immunotherapy can be combined with non-immune based treatment options we first
need to investigate the effects of non-immune based therapies on immune responses
(especially immune-evasive mechanisms) with cancer.
- Commensal gut microbiota play an important role in colonic inflammation and colon
cancer. The human gut flora consists of approximately 100 trillion microbial cells,
which their disruption leads to many types of diseases including inflammatory bowel
disease and colorectal cancer. Recent studies have shown that colon cancer patients as
well other patients with gastrointestinal cancers have an altered gut flora when
compared to healthy controls. As an example, intestinal microbiome has been shown to
contribute to the start and progression of certain kinds of liver diseases such as NAFLD
as well as end-stage liver diseases 2-4 Therefore, it is important to investigate
further as to how the gut affects the patient s response to chemotherapy, other types of
cancer therapy and to tumor growth in general.
OBJECTIVES:
To serve as an umbrella protocol to allow collection, storage and investigation of samples
from patients with gastrointestinal (GI) cancers in support of Thoracic and GI Oncology
Branch translational trials to develop new therapeutic agents and novel treatment approaches
as well as new prognostic and diagnostic models. Also, to collect samples from patients with
non-GI cancers for comparison.
ELIGIBILITY:
- Patients undergoing evaluation for participation in NCI treatment protocols in the NCI
intramural program with diagnosis of cancer.
- 18 year of age or older.
DESIGN:
- Blood, tumor tissue or stool samples may be collected from consenting subjects at the
initial visit and/or at the time of visit to NIH, scheduled per other NIH protocols.
- Analysis of subject s samples include but not limited to immune-monitoring, single cell
sequencing, identifying of gene expression and generation of CAR-T cells.
- Stool samples will be used to determine the intestinal microbiome.
- Numerous recent therapeutic advances have changed standard treatment options for
patients with GI cancer. These include newer chemotherapeutic agents in addition to
established proof of principle for anti-angiogenic agents. The burden of GI cancers is
reflected by the presence of three GI cancer types in the top five causes of cancer
mortality. Over 58,000 deaths yearly can be attributed to GI cancer.
- While immune-based therapies in GI cancers are experimental at the current time, a
gathering body of literature is suggestive of an enormous potential, either alone, or
most likely in combination with standard chemotherapy.
- Before immunotherapy can be combined with non-immune based treatment options we first
need to investigate the effects of non-immune based therapies on immune responses
(especially immune-evasive mechanisms) with cancer.
- Commensal gut microbiota play an important role in colonic inflammation and colon
cancer. The human gut flora consists of approximately 100 trillion microbial cells,
which their disruption leads to many types of diseases including inflammatory bowel
disease and colorectal cancer. Recent studies have shown that colon cancer patients as
well other patients with gastrointestinal cancers have an altered gut flora when
compared to healthy controls. As an example, intestinal microbiome has been shown to
contribute to the start and progression of certain kinds of liver diseases such as NAFLD
as well as end-stage liver diseases 2-4 Therefore, it is important to investigate
further as to how the gut affects the patient s response to chemotherapy, other types of
cancer therapy and to tumor growth in general.
OBJECTIVES:
To serve as an umbrella protocol to allow collection, storage and investigation of samples
from patients with gastrointestinal (GI) cancers in support of Thoracic and GI Oncology
Branch translational trials to develop new therapeutic agents and novel treatment approaches
as well as new prognostic and diagnostic models. Also, to collect samples from patients with
non-GI cancers for comparison.
ELIGIBILITY:
- Patients undergoing evaluation for participation in NCI treatment protocols in the NCI
intramural program with diagnosis of cancer.
- 18 year of age or older.
DESIGN:
- Blood, tumor tissue or stool samples may be collected from consenting subjects at the
initial visit and/or at the time of visit to NIH, scheduled per other NIH protocols.
- Analysis of subject s samples include but not limited to immune-monitoring, single cell
sequencing, identifying of gene expression and generation of CAR-T cells.
- Stool samples will be used to determine the intestinal microbiome.
- INCLUSION CRITERIA:
- Patients 18 years of age and older
- Patients with a diagnosis of cancer
- Patients must be willing to provide informed consent
EXCLUSION CRITERIA:
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: (888) NCI-1937
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