Gastric CancerNCT00582257
Early Onset and Familial Gastric Cancer Registry
An observational study of Gastric Cancer, run by Memorial Sloan Kettering Cancer Center at 10 sites in 2 countries.
Trial summary
The purpose of this study is to establish a gastric cancer registry. A registry is a database of information. With the registry, we can learn more about the genetic causes of gastric cancer in order to develop better methods of early diagnosis, prevention, and treatment of gastric cancers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 971 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 13 Dec 2005to 30 Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at MSK or collaborating centers. If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participation and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study.
Who may be able to join
- Patient/Relative Cohort:
- Must meet one or more criteria below:
- A person with a diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed at the treating institution.
- A person without gastric or GEJ adenocarcinoma who has or had a first degree relative eligible for a High Risk Genetic sub-group (EOGC/FGC).
- Early Onset Gastric Cancer - diagnosis of gastric cancer before the age of 50 without a family history of the disease.
- Familial Gastric Cancer - having a family history of gastric cancer as defined as one first degree relative or 2 second degree relatives.
Show all 13Show fewer
- A person without gastric or GEJ adenocarcinoma who has a personal family history of a genetic mutation associated with the development of gastric or GEJ adenocarcinoma (i.e. family history of CDH1 mutation).
- Must be willing to provide a blood sample for germline DNA. These individuals will sign the "Patient/Relative Consent". Following enrollment, we will assign individuals to the appropriate High Genetic Risk or Low Genetic Risk groups based on the age of diagnosis and their family history.
- Subject Exclusion Criteria
- Patients are ineligible for the study if they:
- Have any condition, which in the opinion of the primary MSK clinician or investigators precludes their ability to provide informed consent.
- Relatives of patients that are not eligible for the High Genetic Risk Cohorts who are less than 18 years of age are excluded.
- Relatives of patients eligible for the High Genetic Risk Cohorts who do not have a proband available to join the study are excluded. (Unless there is a known CDH1 mutation in the family).
Who cannot join
None listed.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center at Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
East White Plains, New York, 10604
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
University of Southern California - Norris Cancer Hospital
Los Angeles, California, 90033
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medical Center
New York, New York, 10065
Memorial Sloan Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, 11570
About this study
The purpose of this study is to establish a gastric cancer registry. A registry is a database of information. With the registry, we can learn more about the genetic causes of gastric cancer in order to develop better methods of early diagnosis, prevention, and treatment of gastric cancers. As part of this study, you will be asked to join a registry of families who are affected with various forms of gastric cancer. These registries are important because they may help physicians better manage gastric cancer now and in the future. Participating in the Early Onset and Familial Gastric Cancer Registry can also be educational for families, since it will provide important information to patients, families, and physicians. All of this will help to further our understanding of genetic causes of gastric cancer and eventually, help determine better ways to diagnose, treat, and survey patients with gastric cancer and people who may have a higher risk for gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- questionnaires
- Keywords
- Gastric Cancer, Stomach Cancer, 05-118
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesBehavioural
Also called At outside centers, recruitment procedures are similar to the procedures at, MSK with the following two exceptions: Due to practice patterns, it may not, be feasible to obtain "Control Cohort" patients. Collaborating sites may, participate in the study without opening a "Control Cohort" after discussion
Participation in the registry will consist of adequately completing the family history questionnaire (one per family) the gastric cancer risk factor questionnaire and providing a blood sample for future correlative studies. Registry participants (both Patient/Relative and Control cohorts) will be required to submit tissue (both normal and/or tumor) to create a Tissue and DNA repository. Select participants will be invited to undergo Genetic Counseling, eg. those participants who meet clinical criteria for HDGC.
| Study group | Role | What they receive |
|---|---|---|
| High Genetic Risk: | Early Onset Gastric Cancer - diagnosis of gastric cancer before the age of 50 without a family history of the disease.
Familial Gastric Cancer - having a family history of gastric cancer as defined as one first degree relative or 2 second degree relatives.
Relative - Relatives of participants eligible for the High Genetic Risk Cohort will be eligible for participation. These relatives may also be at high risk of developing gastric cancer. These individuals will fall under the Cancer Cohort. Eligible relatives will be defined as someone having a relative who meets criteria for either the Early Onset Cancer Cohort or the Familial Gastric Cancer Cohort, or having a family history of a genetic mutation known to be associated with gastric cancer. Receives: Behavioral: questionnaires | |
| Low Genetic Risk: Closed to Accrual | Sporadic Gastric Cancer - gastric cancer that appears to have occurred by random or sporadic mutation. Specifically, a patient with gastric cancer not eligible for either High Genetic Risk cohort.
Control (closed to accrual) - A participant that is not a blood relative of a patient or relative participant, without gastric cancer and without a family history of a CDH1 gene mutation. Select MSK participants with Hereditary Diffuse Gastric Cancer with identified CDH1 germline genetic mutation will be invited by MSKCC only to complete the onetime Pre-implantation Genetic Diagnosis (HDGC PGD) survey. These patients may be verbally consented over the telephone. Receives: Behavioral: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Create registry of families w/ early onset & familial gastric cancer for analysis of risk factors, family history and unidentified susceptibility genes. Create cohorts of pts w/ low genetic risk for the development of gastric cancer
Measured: December 2010
Secondary outcomes (2)
To determine the incidence of CDH1 germline mutations among individuals with early onset or familial gastric cancer and their relatives.
Measured: December 2010
To determine the gastric pathology evident from a single baseline endoscopic screen of unaffected first-degree relatives of a patient with EOGC or FGC.
Measured: December 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study start13 Dec 2005
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 971 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, Queens Health Network, University of Southern California, Shaare Zedek Medical Center, Obafemi Awolowo University Teaching Hospital
- Responsible party
- Sponsor
- Investigators
- David Kelsen, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582257
- Sponsor's protocol ID
- 05-118
- Status last verified
- Oct 2024
- First submitted
- 21 Dec 2007
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Onset and Familial Gastric Cancer Registry
- ClinicalTrials.gov ID
- NCT00582257
- Acronym / sponsor ID
- 05-118
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Stomach Cancer, 05-118
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 971 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, Queens Health Network, University of Southern California, Shaare Zedek Medical Center, Obafemi Awolowo University Teaching Hospital
- Study start
- 13 Dec 2005 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 28 Dec 2007 (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.
The purpose of this study is to establish a gastric cancer registry. A registry is a database of information. With the registry, we can learn more about the genetic causes of gastric cancer in order to develop better methods of early diagnosis, prevention, and treatment of gastric cancers. As part of this study, you will be asked to join a registry of families who are affected with various forms of gastric cancer. These registries are important because they may help physicians better manage gastric cancer now and in the future. Participating in the Early Onset and Familial Gastric Cancer Registry can also be educational for families, since it will provide important information to patients, families, and physicians. All of this will help to further our understanding of genetic causes of gastric cancer and eventually, help determine better ways to diagnose, treat, and survey patients with gastric cancer and people who may have a higher risk for gastric cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Genetic Risk: | – | Behavioral: questionnairesEarly Onset Gastric Cancer - diagnosis of gastric cancer before the age of 50 without a family history of the disease. Familial Gastric Cancer - having a family history of gastric cancer as defined as one first degree relative or 2 second degree relatives. Relative - Relatives of participants eligible for the High Genetic Risk Cohort will be eligible for participation. These relatives may also be at high risk of developing gastric cancer. These individuals will fall under the Cancer Cohort. Eligible relatives will be defined as someone having a relative who meets criteria for either the Early Onset Cancer Cohort or the Familial Gastric Cancer Cohort, or having a family history of a genetic mutation known to be associated with gastric cancer. |
| Low Genetic Risk: Closed to Accrual | – | Behavioral: questionnairesSporadic Gastric Cancer - gastric cancer that appears to have occurred by random or sporadic mutation. Specifically, a patient with gastric cancer not eligible for either High Genetic Risk cohort. Control (closed to accrual) - A participant that is not a blood relative of a patient or relative participant, without gastric cancer and without a family history of a CDH1 gene mutation. Select MSK participants with Hereditary Diffuse Gastric Cancer with identified CDH1 germline genetic mutation will be invited by MSKCC only to complete the onetime Pre-implantation Genetic Diagnosis (HDGC PGD) survey. These patients may be verbally consented over the telephone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at MSK or collaborating centers. If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participation and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study.
Key inclusion criteria (13 listed)
- A person with a diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed at the treating institution.
- A person without gastric or GEJ adenocarcinoma who has or had a first degree relative eligible for a High Risk Genetic sub-group (EOGC/FGC).
- A person without gastric or GEJ adenocarcinoma who has a personal family history of a genetic mutation associated with the development of gastric or GEJ adenocarcinoma (i.e. family history of CDH1 mutation).
- Must be willing to provide a blood sample for germline DNA. These individuals will sign the "Patient/Relative Consent". Following enrollment, we will assign individuals to the appropriate High Genetic Risk or Low Genetic Risk groups based on the age of diagnosis and their family history.
- Subject Exclusion Criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesAlso: At outside centers, recruitment procedures are similar to the procedures at, MSK with the following two exceptions: Due to practice patterns, it may not, be feasible to obtain "Control Cohort" patients. Collaborating sites may, participate in the study without opening a "Control Cohort" after discussionParticipation in the registry will consist of adequately completing the family history questionnaire (one per family) the gastric cancer risk factor questionnaire and providing a blood sample for future correlative studies. Registry participants (both Patient/Relative and Control cohorts) will be required to submit tissue (both normal and/or tumor) to create a Tissue and DNA repository. Select participants will be invited to undergo Genetic Counseling, eg. those participants who meet clinical criteria for HDGC. | Behavioural | High Genetic Risk:, Low Genetic Risk: Closed to Accrual |
Primary outcome
Create registry of families w/ early onset & familial gastric cancer for analysis of risk factors, family history and unidentified susceptibility genes. Create cohorts of pts w/ low genetic risk for the development of gastric cancer
Time frame: December 2010
2 secondary outcomes
To determine the incidence of CDH1 germline mutations among individuals with early onset or familial gastric cancer and their relatives.
Time frame: December 2010
To determine the gastric pathology evident from a single baseline endoscopic screen of unaffected first-degree relatives of a patient with EOGC or FGC.
Time frame: December 2010
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 3 Oct 2024.
- Memorial Sloan Kettering Cancer Center websiteLink provided by the sponsor.
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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.
David Kelsen, MD principal investigator
Memorial Sloan Kettering Cancer Center
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Memorial Sloan Kettering Cancer Center at 10 sites in 2 countries.
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 13 inclusion and 0 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 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Nigeria. 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?
Create registry of families w/ early onset & familial gastric cancer for analysis of risk factors, family history and unidentified susceptibility genes. Create cohorts of pts w/ low genetic risk for the development of gastric cancer (time frame: December 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2024.