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Prospective Evaluation and Molecular Profiling in People With Gastric Tumors

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ClinicalTrials.gov Identifier: NCT03027427
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief 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.


Condition or disease
Stomach Neoplasms Stomach Cancer

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.
  • It is anticipated that the protocol will enroll a maximum of 250 patients.

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation and Molecular Profiling in Patients With Gastric Tumors
Study Start Date : January 12, 2017
Estimated Primary Completion Date : August 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Group/Cohort
Patients
Patients with confirmation of, or suspicion of, a heritable gastric malignancy disorder



Primary Outcome Measures :
  1. Determination of eligibility [ Time Frame: At intial visit ]
    Determination of eligibility



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with confirmation of, or suspicion of, a heritable gastric malignancy disorder
Criteria
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027427


Contacts
Contact: Maureen F Connolly (301) 435-5613 connollymf@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jeremy L Davis, M.D. National Cancer Institute (NCI)

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03027427     History of Changes
Other Study ID Numbers: 170044
17-C-0044
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: December 27, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Screening
Heritable Gastric Malignancy
Molecular Profiling
Molecular Alterations

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases