Clinical trial NCT03027427: Prospective Evaluation and Molecular Profiling in People With Gastric Tumors
Official title: Prospective Evaluation and Molecular Profiling in Patients With Gastric Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stomach Neoplasms
Stomach Cancer
Keywords: Screening
Heritable Gastric Malignancy
Molecular Profiling
Molecular Alterations
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2017-01-23
Enrollment: 109
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmation of, or suspicion of, a heritable gastric malignancy disorder

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:

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.

Eligibility criteria: * 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.

Primary outcomes:
measure: Long-term follow up to support clinical and preclinical research
timeFrame: follow up
measure: Determination of eligibility
timeFrame: at initial visit
measure: Clinical and laboratory evaluation and molecular profiling of tumor tissue
timeFrame: at initial visit and as clinically indicated
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Andrew M Blakely, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Cristescu 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.
citation: Cancer 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.