Prospective Evaluation and Molecular Profiling in People With Gastric Tumors
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 3/27/2019 |
| Start Date: | February 1, 2017 |
| End Date: | December 31, 2026 |
| Contact: | NIH Foregut Team |
| Email: | foregut@mail.nih.gov |
| Phone: | (240) 858-3610 |
Prospective Evaluation and Molecular Profiling in Patients With Gastric Tumors
Background:
Certain stomach cancers are rare, but they have high mortality rates. Researchers want to
learn more about gastric (stomach) tumors. In this study, they want to collect data from
people who have stomach cancer or are at risk to get it. This data will be used to see if the
people can be in other studies.
Objective:
To study tissue from stomach tumors and find people eligible for more studies on gastric
cancer.
Eligibility:
Adults at least 18 years old who have or may have stomach cancer, lesions that may be related
to stomach cancer, or an inherited disorder that leads to stomach cancer.
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
Heart tests
Scans or ultrasound.
For the scans, participants lie in a machine that takes pictures. For some scans, they will
swallow or be injected with a small amount of radioactive material. Special cameras will show
the material in the body.
Tumor sample taken with a needle or surgery
Some participants will have an endoscopy. A long, flexible tube with a camera will be
inserted through the mouth into the stomach. The tube will collect tissue from the stomach.
Some participants may have follow-up visits. Some may be invited to join other studies.
Others will be contacted by phone to see how they are doing.
Certain stomach cancers are rare, but they have high mortality rates. Researchers want to
learn more about gastric (stomach) tumors. In this study, they want to collect data from
people who have stomach cancer or are at risk to get it. This data will be used to see if the
people can be in other studies.
Objective:
To study tissue from stomach tumors and find people eligible for more studies on gastric
cancer.
Eligibility:
Adults at least 18 years old who have or may have stomach cancer, lesions that may be related
to stomach cancer, or an inherited disorder that leads to stomach cancer.
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
Heart tests
Scans or ultrasound.
For the scans, participants lie in a machine that takes pictures. For some scans, they will
swallow or be injected with a small amount of radioactive material. Special cameras will show
the material in the body.
Tumor sample taken with a needle or surgery
Some participants will have an endoscopy. A long, flexible tube with a camera will be
inserted through the mouth into the stomach. The tube will collect tissue from the stomach.
Some participants may have follow-up visits. Some may be invited to join other studies.
Others will be contacted by phone to see how they are doing.
Background:
- Greater than 90% of gastric tumors are of epithelial origin and are classified as
adenocarcinomas; the remainders include GIST, carcinoid and lymphoma
- Gastric adenocarcinoma is rare in the United States (incidence 7.4 per 100,000)
- Mortality rates are high with an estimated 5-year overall survival of 25% - 30%
- Up to 3% of gastric adenocarcinomas occur as part of a heritable cancer syndrome
- Molecular sub-classification of gastric adenocarcinomas has been reported, however
translation of these findings into clinical management of patients has yet to occur
Objectives:
- To permit clinical and laboratory evaluation and molecular profiling of tumor tissue
from patients with gastric malignancies or non-invasive (neoplastic) conditions
- Assess eligibility for enrollment in studies of gastric cancer conducted in the CCR
- To allow long-term follow up of patients with gastric tumors, or heritable gastric
malignancy syndromes, to support clinical and preclinical research particularly related
to molecular alterations in gastric tumors and their response to therapy
Eligibility:
Patients with the following are eligible:
- histologically or cytologically confirmed malignant lesions or non-invasive (neoplastic)
conditions of the stomach; or
- suspicious lesion not yet confirmed, but considered likely related to the stomach
pending further evaluation; or
- confirmation of, or suspicion of, a heritable gastric malignancy disorder; or
- Age greater than or equal to 18 years.
Design:
- This protocol is designed to facilitate clinical evaluation, molecular tumor profiling,
and long-term follow up of patients with gastric tumors
- Patients will be screened and clinical evaluation performed to determine eligibility for
other CCR trials for gastric tumors
- No investigational treatment will be administered and no procedures will be done for
only research purposes on this protocol.
- It is anticipated that the protocol will enroll a maximum of 250 patients.
- Greater than 90% of gastric tumors are of epithelial origin and are classified as
adenocarcinomas; the remainders include GIST, carcinoid and lymphoma
- Gastric adenocarcinoma is rare in the United States (incidence 7.4 per 100,000)
- Mortality rates are high with an estimated 5-year overall survival of 25% - 30%
- Up to 3% of gastric adenocarcinomas occur as part of a heritable cancer syndrome
- Molecular sub-classification of gastric adenocarcinomas has been reported, however
translation of these findings into clinical management of patients has yet to occur
Objectives:
- To permit clinical and laboratory evaluation and molecular profiling of tumor tissue
from patients with gastric malignancies or non-invasive (neoplastic) conditions
- Assess eligibility for enrollment in studies of gastric cancer conducted in the CCR
- To allow long-term follow up of patients with gastric tumors, or heritable gastric
malignancy syndromes, to support clinical and preclinical research particularly related
to molecular alterations in gastric tumors and their response to therapy
Eligibility:
Patients with the following are eligible:
- histologically or cytologically confirmed malignant lesions or non-invasive (neoplastic)
conditions of the stomach; or
- suspicious lesion not yet confirmed, but considered likely related to the stomach
pending further evaluation; or
- confirmation of, or suspicion of, a heritable gastric malignancy disorder; or
- Age greater than or equal to 18 years.
Design:
- This protocol is designed to facilitate clinical evaluation, molecular tumor profiling,
and long-term follow up of patients with gastric tumors
- Patients will be screened and clinical evaluation performed to determine eligibility for
other CCR trials for gastric tumors
- No investigational treatment will be administered and no procedures will be done for
only research purposes on this protocol.
- It is anticipated that the protocol will enroll a maximum of 250 patients.
- INCLUSION CRITERIA:
- Patients with the following are eligible:
- malignant or non-invasive, neoplastic lesions of the stomach confirmed by
histopathology or cytopathology in a CLIA-certified laboratory
OR
--suspicious lesions not yet confirmed, but considered likely to be related to the stomach
pending further evaluation
OR
--confirmed, deleterious germline mutation
- Patients with a family history of gastric cancer or suspicion of a heritable gastric
malignancy disorder
- Patients must have an ECOG performance score of 0-2.
- Age greater than or equal to 18 years
- The patient is a candidate for the clinically indicated medical evaluations that are
being offered
- The patient or legally authorized representative (LAR) must be willing to sign an
Informed Consent, and undergo clinically indicated testing
EXCLUSION CRITERIA:
Candidates who do not meet the inclusion criteria.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 888-624-1937
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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