Prospective Evaluation and Molecular Profiling in People With Gastric Tumors (NCT03027427) | Clinical Trial Compass
CompletedNot Applicable
Prospective Evaluation and Molecular Profiling in People With Gastric Tumors
United States109 participantsStarted 2017-02-01
Plain-language 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.
...
Who can participate
Age range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Patients with any of the following are eligible:
* Malignant or non-invasive, neoplastic lesions of the stomach confirmed by histopathology or cytopathology in a CLIA-certified laboratory;
* Suspicious lesions not yet confirmed, but considered likely to be 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.
* Patients must have an ECOG performance score of 0-2.
* Age greater than or equal to 2 years. Note: Patients greater than or equal to 2 and less than or equal to 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the sampling of tissue, blood and urine does not add risk to the clinically indicated procedures.
* The patient is a candidate for the clinically indicated medical evaluations that are being offered
* Ability of subject, their parents/guardians or legally authorized representative (LAR) to understand and must be willing to sign a written informed consent document.
EXCLUSION CRITERIA:
Candidates who do not meet the inclusion criteria.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Long-term follow up to support clinical and preclinical research
Timeframe: follow up
2
Determination of eligibility
Timeframe: at initial visit
3
Clinical and laboratory evaluation and molecular profiling of tumor tissue
Timeframe: at initial visit and as clinically indicated