Prospective Evaluation and Molecular Profiling in Patients With Gastric Tumors
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- STATUS
- Recruiting
-
- End date
- Dec 31, 2030
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- participants needed
- 250
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- sponsor
- National Cancer Institute (NCI)
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
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.
...
Description
- Background
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- 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:
- Malignant or non-invasive, neoplastic lesions of the stomach confirmed by histopathology or cytopathology;
- Suspicious lesion 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.
Details
| Condition | Stomach Neoplasms, Stomach Cancer |
|---|---|
| Clinical Study Identifier | NCT03027427 |
| Sponsor | National Cancer Institute (NCI) |
| Last Modified on | 21 October 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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