Stomach NeoplasmsNCT03027427
Prospective Evaluation and Molecular Profiling in People With Gastric Tumors
An observational study of Stomach Neoplasms and Stomach Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Stomach Neoplasms, Stomach Cancer
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 6 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with confirmation of, or suspicion of, a heritable gastric malignancy disorder
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- Candidates who do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Prospective Evaluation and Molecular Profiling in Patients With Gastric Tumors
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.
Read more
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.
...
Read the 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 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.
- Conditions
- Stomach Neoplasms, Stomach Cancer
- Keywords
- Screening, Heritable Gastric Malignancy, Molecular Profiling, Molecular Alterations
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with confirmation of, or suspicion of, a heritable gastric malignancy disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term follow up to support clinical and preclinical research
long-term follow up of patients with gastric tumors, or heritable gastric malignancy syndromes screened on this study, to support clinical and preclinical research particularly related to molecular alterations in gastric tumors and their response to therapy
Measured: follow up
Determination of eligibility
determination of eligibility for enrollment in studies of gastric cancer conducted in the CCR
Measured: at initial visit
Clinical and laboratory evaluation and molecular profiling of tumor tissue
Tissue samples collected to permit clinical and laboratory evaluation and molecular profiling of tumor tissue from patients with gastric malignancies or non-invasive (neoplastic) conditions
Measured: at initial visit and as clinically indicated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion20 Jun 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Andrew M Blakely, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027427
- Sponsor's protocol ID
- 170044
- Other IDs
- 17-C-0044
- Status last verified
- Feb 2025
- First submitted
- 18 Jan 2017
- Last updated
- 28 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Publications
Wang K, Yuen ST, Xu J, Lee SP, Yan HH, Shi ST, Siu HC, Deng S, Chu KM, Law S, Chan KH, Chan AS, Tsui WY, Ho SL, Chan AK, Man JL, Foglizzo V, Ng MK, Chan AS, Ching YP, Cheng GH, Xie T, Fernandez J, Li VS, Clevers H, Rejto PA, Mao M, Leung SY. Whole-genome sequencing and comprehensive molecular profiling identify new driver mutations in gastric cancer. Nat Genet. 2014 Jun;46(6):573-82. doi: 10.1038/ng.2983. Epub 2014 May 11.
PubMed 24816253Cristescu R, Lee J, Nebozhyn M, Kim KM, Ting JC, Wong SS, Liu J, Yue YG, Wang J, Yu K, Ye XS, Do IG, Liu S, Gong L, Fu J, Jin JG, Choi MG, Sohn TS, Lee JH, Bae JM, Kim ST, Park SH, Sohn I, Jung SH, Tan P, Chen R, Hardwick J, Kang WK, Ayers M, Hongyue D, Reinhard C, Loboda A, Kim S, Aggarwal A. Molecular analysis of gastric cancer identifies subtypes associated with distinct clinical outcomes. Nat Med. 2015 May;21(5):449-56. doi: 10.1038/nm.3850. Epub 2015 Apr 20.
PubMed 25894828Cancer Genome Atlas Research Network. Comprehensive molecular characterization of gastric adenocarcinoma. Nature. 2014 Sep 11;513(7517):202-9. doi: 10.1038/nature13480. Epub 2014 Jul 23.
PubMed 25079317
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation and Molecular Profiling in Patients With Gastric Tumors
- ClinicalTrials.gov ID
- NCT03027427
- Acronym / sponsor ID
- 170044
- Conditions
- Stomach Neoplasms, Stomach Cancer
- Keywords
- Screening, Heritable Gastric Malignancy, Molecular Profiling, Molecular Alterations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients with confirmation of, or suspicion of, a heritable gastric malignancy disorder |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with confirmation of, or suspicion of, a heritable gastric malignancy disorder
Key inclusion criteria (10 listed)
- Patients with any of the following are eligible:
- 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.
Key exclusion criteria (1 listed)
- Candidates who do not meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long-term follow up to support clinical and preclinical research
Time frame: follow up
long-term follow up of patients with gastric tumors, or heritable gastric malignancy syndromes screened on this study, to support clinical and preclinical research particularly related to molecular alterations in gastric tumors and their response to therapy
Determination of eligibility
Time frame: at initial visit
determination of eligibility for enrollment in studies of gastric cancer conducted in the CCR
Clinical and laboratory evaluation and molecular profiling of tumor tissue
Time frame: at initial visit and as clinically indicated
Tissue samples collected to permit clinical and laboratory evaluation and molecular profiling of tumor tissue from patients with gastric malignancies or non-invasive (neoplastic) conditions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Background: PubMed 24816253Wang K, Yuen ST, Xu J, Lee SP, Yan HH, Shi ST, Siu HC, Deng S, Chu KM, Law S, Chan KH, Chan AS, Tsui WY, Ho SL, Chan AK, Man JL, Foglizzo V, Ng MK, Chan AS, Ching YP, Cheng GH, Xie T, Fernandez J, Li VS, Clevers H, Rejto PA, Mao M, Leung SY. Whole-genome sequencing and comprehensive molecular profiling identify new driver mutations in gastric cancer. Nat Genet. 2014 Jun;46(6):573-82. doi: 10.1038/ng.2983. Epub 2014 May 11.
- Background: PubMed 25894828Cristescu R, Lee J, Nebozhyn M, Kim KM, Ting JC, Wong SS, Liu J, Yue YG, Wang J, Yu K, Ye XS, Do IG, Liu S, Gong L, Fu J, Jin JG, Choi MG, Sohn TS, Lee JH, Bae JM, Kim ST, Park SH, Sohn I, Jung SH, Tan P, Chen R, Hardwick J, Kang WK, Ayers M, Hongyue D, Reinhard C, Loboda A, Kim S, Aggarwal A. Molecular analysis of gastric cancer identifies subtypes associated with distinct clinical outcomes. Nat Med. 2015 May;21(5):449-56. doi: 10.1038/nm.3850. Epub 2015 Apr 20.
- Background: PubMed 25079317Cancer Genome Atlas Research Network. Comprehensive molecular characterization of gastric adenocarcinoma. Nature. 2014 Sep 11;513(7517):202-9. doi: 10.1038/nature13480. Epub 2014 Jul 23.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew M Blakely, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasms and Stomach Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term follow up to support clinical and preclinical research (time frame: follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03027427, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.