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:
Age greater than or equal to 2 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.
...
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03027427.
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 any of the following are eligible:
- Malignant or non-invasive, neoplastic lesions of the stomach confirmed by
histopathology or cytopathology;
- Suspicious lesions not yet confirmed, but considered likely related to the stomach
pending further evaluation;
- Confirmed, deleterious germline mutation (including but not limited to HDGC, GAPPS)
known to predispose to gastric tumors;
- Confirmed or suspicious heritable gastric malignancy disorder;
- Clinically suspicious personal or family medical history of gastric cancer or
gastric cancer syndrome that warrants genetics evaluation.
- Age greater than or equal to 2 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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationNational Cancer Institute
Principal InvestigatorJeremy L Davis
