Malignant Neoplasm of StomachFamGaCanNCT01727908
Screening for Familial Gastric Cancer in First Degree Relatives
A study testing Endoscopy with staining of the mucosa in people with Malignant Neoplasm of Stomach and Carcinoma, Diffuse Type, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether staining of the gastric mucosa increases the number of detected (pre)malignant foci of intestinal and diffuse type gastric cancer, in first degree relatives of individuals with familial gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm of Stomach, Carcinoma, Diffuse Type, Intestinal Type Adenocarcinoma of Stomach
- What is being tested?
- Endoscopy with staining of the mucosa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2012to Sep 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult (≥ 18 yrs), female and male relatives
- fully legal competent (to simplify the common consent agreement for blood withdrawal, DNA analysis and serial endoscopies.)
- individuals that signed the common consent agreement
- first degree relative of an individual with diffuse gastric cancer from a FDGC-family, without proven mutation,
- OR: 2 or more individuals with gastric carcinoma, at least one < 50 yrs
- OR: 3 or more individuals with (diffuse/intestinal/other type) gastric carcinoma, any age
- OR 1 individual with any type gastric carcinoma < 40 yrs
Who cannot join
- immature individuals
- actual gastric ulcer or gastric bleeding
- previous diagnosis of gastric cancer
- hypersensitivity to Indigocarmine
- individuals with co-morbidity which might increase the sedation and/or endoscopy risk: COPD Gold III/IV Cardiac failure Increased bleeding tendency or use of medication which increases bleeding tendency
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre
Nijmegen, PO BOX 9101, 6500HB
About this study
The purpose of this study is to determine whether staining of the gastric mucosa increases the number of detected (pre)malignant foci of intestinal and diffuse type gastric cancer, in first degree relatives of individuals with familial gastric cancer.
Read the detailed description
Rationale:
Familial gastric cancer (FGC) concerns about 10% of all gastric cancers. It has an impressive impact on both emotional and physical wellbeing of first degree relatives of patients with (early) onset of gastric cancer. FGC can in 1-3% be attributed to one single hereditary syndrome, the hereditary diffuse gastric cancer (HDGC). HDGC is associated with a CDH1 mutation in about 40 % of the cases. In case there is no CDH1 mutation, referred to as familiar diffuse gastric cancer (FDGC), it remains uncertain how to guide and/or screen family members. The same applies for the rare familial intestinal type gastric cancer (FIGC).
Aim:
In this study we want to determine the value of endoscopic screening in members of families with FGC, both FDGC and FIGC. Also, we will analyze the associations of life style factors, including dietary habits with the development of FDGC, to be able to built preventive strategies. Finally, we want to assess the psychological impact of our screening protocol.
Objective:
Primary, to determine whether staining of the gastric mucosa increases the number of detected (pre)malignant foci of diffuse type gastric cancer, in individuals from families with FDGC as well as dysplastic, adenomatous and early intestinal cancers in individuals from families with FIGC. Secondary: A To determine the optimal pathological work-up the detection rate of (pre-)malignancy. B To determine clinical and life style factors that are associated with the two types of FGC. C To determine the psychosocial impact of the screening protocol in this population. D To develop a strategy for screening individuals from FGC families and creative advise for preventive measures.
Study design:
A randomized controlled trial included in a prospective cohort analysis.
Study population:
All (first degree) relatives , from 18 years and older from patients who fulfill the criteria for a FGC. These are; 1] all first degree relatives of an individual with diffuse gastric cancer, without proven CDH1 mutation, or members from families with 2] 2 or more individuals with gastric carcinoma, at least one < 50 yrs, or 3] 3 or more individuals with gastric carcinoma, any age, any type, or 4] 1 individual with any type gastric carcinoma < 40 yrs.
- Conditions
- Malignant Neoplasm of Stomach, Carcinoma, Diffuse Type, Intestinal Type Adenocarcinoma of Stomach, Relative (Related Person)
- Being tested
- Endoscopy with staining of the mucosa
- Keywords
- Familial Gastric Cancer Screening
- Medical subject headings
- Stomach Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopy with staining of the mucosaOther
Staining of the gastric mucosa with acetic acid and Indigocarmine
| Study group | Role | What they receive |
|---|---|---|
| Endoscopy without staining of the mucosa | No intervention | Not described |
| Endoscopy with staining of the mucosa. | Experimental | Not described Receives: Other: Endoscopy with staining of the mucosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of increasement of endoscopic detection of (pre)malignant for gastric cancer by staining of the gastric mucosa.
Measured: all patients will have a follow up of five years, during which four endoscopies will be performed
Secondary outcomes (3)
To determine the optimal pathological work-up the detection rate of (pre-)malignancy, measured by the number of (pre) malignant foci found by the pathologist with different coloring and immunohistochemic techniques.
Measured: all patients will have a follow up of five years, during which four endoscopies with biopsy sampling will be performed
To determine the association of clinical and life style factors with the two type of Familial Gastric Cancer, partly assessed from the patients'clinical files (eg BMI), partly by assessment of possible risk factors in blood (eg Helicobacter Pylori).
Measured: after three years of follow up these data will be assessed
To determine the psychosocial impact of the screening protocol in this population, measured as the amount of stress and anxiety by use of the Hospital Anxiety and Distress Scale and the amount of cancer-worry by use of the Cancer Worry Scale.
Measured: during the follow up period of five years, each patient will receive questionaires at six time points. Assessment of these data will be performed after finishing the follow-up of the last patient, about six years after the start of this study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: guideline developed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of StomachStudies of the same condition, open and under way.
- More trials run by Radboud University Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanya M Bisseling, M.D.Ph.D., Principal investigator, Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical CentreFokko M Nagengast, M.D.Ph.D., Principal investigator, Department of Gastroenterology and Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727908
- Sponsor's protocol ID
- Protocol ID 2012/270
- Acronym
- FamGaCan
- Status last verified
- Apr 2017
- First submitted
- 8 Nov 2012
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Familial Gastric Cancer in First Degree Relatives
- ClinicalTrials.gov ID
- NCT01727908
- Acronym / sponsor ID
- FamGaCan / Protocol ID 2012/270
- Conditions
- Malignant Neoplasm of Stomach, Carcinoma, Diffuse Type, Intestinal Type Adenocarcinoma of Stomach, Relative (Related Person)
- Keywords
- Familial Gastric Cancer Screening
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: guideline developed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 Nov 2012 (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 determine whether staining of the gastric mucosa increases the number of detected (pre)malignant foci of intestinal and diffuse type gastric cancer, in first degree relatives of individuals with familial gastric cancer.
Detailed description
Rationale:
Familial gastric cancer (FGC) concerns about 10% of all gastric cancers. It has an impressive impact on both emotional and physical wellbeing of first degree relatives of patients with (early) onset of gastric cancer. FGC can in 1-3% be attributed to one single hereditary syndrome, the hereditary diffuse gastric cancer (HDGC). HDGC is associated with a CDH1 mutation in about 40 % of the cases. In case there is no CDH1 mutation, referred to as familiar diffuse gastric cancer (FDGC), it remains uncertain how to guide and/or screen family members. The same applies for the rare familial intestinal type gastric cancer (FIGC).
Aim:
In this study we want to determine the value of endoscopic screening in members of families with FGC, both FDGC and FIGC. Also, we will analyze the associations of life style factors, including dietary habits with the development of FDGC, to be able to built preventive strategies. Finally, we want to assess the psychological impact of our screening protocol.
Objective:
Primary, to determine whether staining of the gastric mucosa increases the number of detected (pre)malignant foci of diffuse type gastric cancer, in individuals from families with FDGC as well as dysplastic, adenomatous and early intestinal cancers in individuals from families with FIGC. Secondary: A To determine the optimal pathological work-up the detection rate of (pre-)malignancy. B To determine clinical and life style factors that are associated with the two types of FGC. C To determine the psychosocial impact of the screening protocol in this population. D To develop a strategy for screening individuals from FGC families and creative advise for preventive measures.
Study design:
A randomized controlled trial included in a prospective cohort analysis.
Study population:
All (first degree) relatives , from 18 years and older from patients who fulfill the criteria for a FGC. These are; 1] all first degree relatives of an individual with diffuse gastric cancer, without proven CDH1 mutation, or members from families with 2] 2 or more individuals with gastric carcinoma, at least one < 50 yrs, or 3] 3 or more individuals with gastric carcinoma, any age, any type, or 4] 1 individual with any type gastric carcinoma < 40 yrs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopy without staining of the mucosa | No intervention | – |
| Endoscopy with staining of the mucosa. | Experimental | Other: Endoscopy with staining of the mucosa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- adult (≥ 18 yrs), female and male relatives
- fully legal competent (to simplify the common consent agreement for blood withdrawal, DNA analysis and serial endoscopies.)
- individuals that signed the common consent agreement
- first degree relative of an individual with diffuse gastric cancer from a FDGC-family, without proven mutation,
Key exclusion criteria (5 listed)
- immature individuals
- actual gastric ulcer or gastric bleeding
- previous diagnosis of gastric cancer
- hypersensitivity to Indigocarmine
- individuals with co-morbidity which might increase the sedation and/or endoscopy risk: COPD Gold III/IV Cardiac failure Increased bleeding tendency or use of medication which increases bleeding tendency
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 |
|---|---|---|
| Endoscopy with staining of the mucosaStaining of the gastric mucosa with acetic acid and Indigocarmine | Other | Endoscopy with staining of the mucosa. |
Primary outcome
The percentage of increasement of endoscopic detection of (pre)malignant for gastric cancer by staining of the gastric mucosa.
Time frame: all patients will have a follow up of five years, during which four endoscopies will be performed
3 secondary outcomes
To determine the optimal pathological work-up the detection rate of (pre-)malignancy, measured by the number of (pre) malignant foci found by the pathologist with different coloring and immunohistochemic techniques.
Time frame: all patients will have a follow up of five years, during which four endoscopies with biopsy sampling will be performed
To determine the association of clinical and life style factors with the two type of Familial Gastric Cancer, partly assessed from the patients'clinical files (eg BMI), partly by assessment of possible risk factors in blood (eg Helicobacter Pylori).
Time frame: after three years of follow up these data will be assessed
To determine the psychosocial impact of the screening protocol in this population, measured as the amount of stress and anxiety by use of the Hospital Anxiety and Distress Scale and the amount of cancer-worry by use of the Cancer Worry Scale.
Time frame: during the follow up period of five years, each patient will receive questionaires at six time points. Assessment of these data will be performed after finishing the follow-up of the last patient, about six years after the start of this study.
Results and safety
The study was stopped early (reason given: guideline developed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
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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.
Tanya M Bisseling, M.D.Ph.D. principal investigator
Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre
Fokko M Nagengast, M.D.Ph.D. principal investigator
Department of Gastroenterology and Hepatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopy with staining of the mucosa in people with Malignant Neoplasm of Stomach and Carcinoma, Diffuse Type, run by Radboud University Medical Center at 1 site in Netherlands.
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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Sep 2019. 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 Netherlands. 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 was stopped early (reason given: guideline developed). Results are not available in the source record.
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?
The percentage of increasement of endoscopic detection of (pre)malignant for gastric cancer by staining of the gastric mucosa. (time frame: all patients will have a follow up of five years, during which four endoscopies will be performed). 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 16 Sep 2019.