Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Prospective Evaluation and Molecular Profiling in People With Gastric Tumors

Summary: 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.

Detailed description: 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 histologically or cytologically confirmed malignant lesions or non-invasive (neoplastic) conditions of the stomach
  -  Patients with a suspicious lesion not yet confirmed, but considered likely related to the stomach pending further evaluation
  -  Patients with confirmation of, or suspicion of, a heritable gastric malignancy disorder
  -  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.
  -  No investigational treatment will be administered on this protocol.
  -  It is anticipated that the protocol will enroll a maximum of 250 patients.

Eligibility: -  INCLUSION CRITERIA:
  1. Patients with malignant or non-invasive, neoplastic lesions of the stomach confirmed by histopathology or cytopathology in a CLIA certified laboratory OR
  2. Patients with suspicious lesions not yet confirmed, but considered likely to be related to the stomach pending further evaluation OR
  3. Patients with a confirmed, deleterious germline mutation
  4. Patients with a family history of gastric cancer or suspicion of a heritable gastric malignancy disorder
  5. Patients must have an ECOG performance score of 0-2.
  6. Age greater than or equal to 18 years
  7. The patient is a candidate for the clinically indicated medical evaluations that are being offered
  8. 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.

Relevance to patient case: not relevant