Hereditary Diffuse Gastric CancerLISA-HDGCNCT04253106
Liquid Biopsies for the Personalized Management of Patients with Hereditary Diffuse Gastric Cancer
A study testing Liquid biopsies (blood, gastric fluid). in people with Hereditary Diffuse Gastric Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Activating somatic mutations and methylation profiles identified by liquid biopsies could identify CDH1 and CTNNA1 pathogenic variants carriers with invasive diffuse gastric cancer undetectable by upper G-I endoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Diffuse Gastric Cancer
- What is being tested?
- Liquid biopsies (blood, gastric fluid).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2020to 10 Apr 2024
- 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
- Case:
- Patient ≥ 18 years old
- CDH1 or CTNNA1 germline pathogenic variant.
- No history of diffuse gastric cancer.
- French social security.
- Ability to understand and willingness to sign a written informed consent document.
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- Volunteers:
- Patients ≥ 18 years old
- Patients with no oncological history
- Patients with macroscopically normal oeso-gastroduodenal fibroscopy
- French social security.
- Ability to understand and willingness to sign a written informed consent
Who cannot join
- Patients with cancer being treated
- Patients with metastatic cancer
- Medical contraindication to general anesthesia or FOGD (bleeding disorder, pregnant women )
- Patients under guardianship or curator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Liquid Biopsies (blood, Gastric Fluid) for the Personalized Management of Patients with Hereditary Diffuse Gastric Cancer: a Pilot Project
Activating somatic mutations and methylation profiles identified by liquid biopsies could identify CDH1 and CTNNA1 pathogenic variants carriers with invasive diffuse gastric cancer undetectable by upper G-I endoscopy.
Read the detailed description
Carriers of germline pathogenic variants in the CDH1 and CTNNA1 genes have the Hereditary Diffuse Gastric Cancer Syndrome. Asymptomatic carriers have at high lifetime risk of diffuse gastric cancer (30-70%). Screening upper gastrointestinal endoscopy, even with multiple random biopsies, misses signet ring cell cancer foci. Invasive cancers can thus go undetected. There is therefore a recommendation of total risk-reducing gastrectomy, at least in carriers with a family history of gastric cancer. Novel screening strategies are needed. In this pilot project, the investigators will perform liquid biopsies of both blood and gastric fluid in asymptomatic carriers who refuse gastrectomy and in controls. The investigators aim to show that somatic mutations in a panel of genes involved in gastric cancer and methylation profiles are detected in a subset of carriers, and not in controls. These could be indicative of invasive cancer undetected by endoscopy, and would thus be a strong argument for risk-reducing gastrectomy. On the contrary, in the absence of somatic mutations in liquid biopsies, endoscopic surveillance could continue.
- Conditions
- Hereditary Diffuse Gastric Cancer
- Being tested
- Liquid biopsies (blood, gastric fluid).
- Keywords
- gastrectomy, somatic mutations, endoscopy, biopsies, methylation profil
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid biopsies (blood, gastric fluid).Genetic
Next generation sequencing of a panel of diffuse gastric cancer genes, methylation analysis. Samples collected during routine screening endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Unaffected carriers of constitutional mutations | Experimental | Patients with CDH1 or CTNNA1 germline pathogenic variant. No history of diffuse gastric cancer. Receives: Genetic: Liquid biopsies (blood, gastric fluid). |
| All patients with FOGD | Active comparator | without observation of macroscopic lesions paired with cases (age and sex) Receives: Genetic: Liquid biopsies (blood, gastric fluid). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects in whom somatic mutations or methylation profiles are detected.
Measured: Over two years of surveillance
Secondary outcomes (1)
Replicability of observations over successive endoscopies. Correlation between blood and gastric fluid.
Measured: Over two years of surveillance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start26 Nov 2020
- Primary completion10 Apr 2024
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Diffuse Gastric CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric, prospective non-randomized study prognostic aim. Control group planned to have standard values.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253106
- Sponsor's protocol ID
- APHP190483
- Acronym
- LISA-HDGC
- Status last verified
- Sep 2024
- First submitted
- 31 Jan 2020
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l\'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsies (blood, Gastric Fluid) for the Personalized Management of Patients with Hereditary Diffuse Gastric Cancer: a Pilot Project
- ClinicalTrials.gov ID
- NCT04253106
- Acronym / sponsor ID
- LISA-HDGC / APHP190483
- Conditions
- Hereditary Diffuse Gastric Cancer
- Keywords
- gastrectomy, somatic mutations, endoscopy, biopsies, methylation profil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 5 Feb 2020 (actual)
- 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.
Activating somatic mutations and methylation profiles identified by liquid biopsies could identify CDH1 and CTNNA1 pathogenic variants carriers with invasive diffuse gastric cancer undetectable by upper G-I endoscopy.
Detailed description
Carriers of germline pathogenic variants in the CDH1 and CTNNA1 genes have the Hereditary Diffuse Gastric Cancer Syndrome. Asymptomatic carriers have at high lifetime risk of diffuse gastric cancer (30-70%). Screening upper gastrointestinal endoscopy, even with multiple random biopsies, misses signet ring cell cancer foci. Invasive cancers can thus go undetected. There is therefore a recommendation of total risk-reducing gastrectomy, at least in carriers with a family history of gastric cancer. Novel screening strategies are needed. In this pilot project, the investigators will perform liquid biopsies of both blood and gastric fluid in asymptomatic carriers who refuse gastrectomy and in controls. The investigators aim to show that somatic mutations in a panel of genes involved in gastric cancer and methylation profiles are detected in a subset of carriers, and not in controls. These could be indicative of invasive cancer undetected by endoscopy, and would thus be a strong argument for risk-reducing gastrectomy. On the contrary, in the absence of somatic mutations in liquid biopsies, endoscopic surveillance could continue.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentric, prospective non-randomized study prognostic aim. Control group planned to have standard values.
| Arm | Type | Receives |
|---|---|---|
| Unaffected carriers of constitutional mutations | Experimental | Genetic: Liquid biopsies (blood, gastric fluid).Patients with CDH1 or CTNNA1 germline pathogenic variant. No history of diffuse gastric cancer. |
| All patients with FOGD | Active comparator | Genetic: Liquid biopsies (blood, gastric fluid).without observation of macroscopic lesions paired with cases (age and sex) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient ≥ 18 years old
- CDH1 or CTNNA1 germline pathogenic variant.
- No history of diffuse gastric cancer.
- French social security.
- Ability to understand and willingness to sign a written informed consent document.
Key exclusion criteria (4 listed)
- Patients with cancer being treated
- Patients with metastatic cancer
- Medical contraindication to general anesthesia or FOGD (bleeding disorder, pregnant women )
- Patients under guardianship or curator
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 |
|---|---|---|
| Liquid biopsies (blood, gastric fluid).Next generation sequencing of a panel of diffuse gastric cancer genes, methylation analysis. Samples collected during routine screening endoscopy. | Genetic | All patients with FOGD, Unaffected carriers of constitutional mutations |
Primary outcome
Number of subjects in whom somatic mutations or methylation profiles are detected.
Time frame: Over two years of surveillance
1 secondary outcome
Replicability of observations over successive endoscopies. Correlation between blood and gastric fluid.
Time frame: Over two years of surveillance
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 23 Sep 2024.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l\'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Related trials for Hereditary Diffuse Gastric Cancer
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CTNNA1 Familial Expansion Study
Cancer Gene Mutation, Gastric Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid biopsies (blood, gastric fluid). in people with Hereditary Diffuse Gastric Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 12 inclusion and 4 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 23 Sep 2024. 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 France. 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?
Number of subjects in whom somatic mutations or methylation profiles are detected. (time frame: Over two years of surveillance). 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 23 Sep 2024.