Gastro-oesophageal AdenocarcinomaBIOPSYGAST MMRNCT04774367
Evaluation of the Reliability of the Determination of MisMatch Repair Deficiency Status by Endoscopic Biopsies in Oesophagus and Gastric Adenocarcinoma.
A study testing Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps and Order of forceps : First large capacity biopsy forceps and second standard biopsy forceps in people with Gastro-oesophageal Adenocarcinoma, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Gastro-esophageal adenocarcinoma is one of the most common cancer in the world and the fourth most common cancer in France with more than 6,000 cases per year. For non-metastatic patients, a preoperative chemotherapy is recommended. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-oesophageal Adenocarcinoma
- What is being tested?
- Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps and Order of forceps : First large capacity biopsy forceps and second standard biopsy forceps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Mar 2026
- 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
- Patient having endoscopy biopsies in front of a suspicious lesion suggestive of gastroesophageal adenocarcinoma
Who cannot join
- Minor patient (<18 years old)
- known pregnancy
- Major patient under tutorship or curatorship
- Contraindication to gastric biopsies
Trial locations and contacts
No sites are listed yet.
About this study
Gastro-esophageal adenocarcinoma is one of the most common cancer in the world and the fourth most common cancer in France with more than 6,000 cases per year. For non-metastatic patients, a preoperative chemotherapy is recommended.
As colorectal adenocarcinomas, gastroesophageal cancers (OGC) could be caused by a failure of DNA repair related to the loss of expression of one of the DNA repair proteins (MLH1, MSH2, PMS2, MSH6) (deficient MMR (dMMR)). The prevalence of tumors with dMMR is evaluated at 14% (Choi et al, 2014; Kim et al, 2015). This proportion reaches 25% among patients over 70 years old. Evidence suggests that patients with dMMR tumors do not benefit from neoadjuvant chemotherapy (Smyth et al, 2017), which may even have a negative impact, especially in elderly patients, and which should be discussed in this particular situation. The decision of neo-adjuvant chemotherapy must be taken very quickly after the endoscopic diagnosis.
Read more
The investigators will evaluate the diagnostic performance of the determination of dMMR status by endoscopic biopsies of OGC.
Moreover, there is no clear recommendation for the determination of dMMR status in OGC especially regarding the size of the forceps to use to ensure the quality of samples and the best molecular techniques for dMMR status determination.
Methods In this prospective study, the investigators will include patients who will benefit from an upper endoscopy within 5 French hospital centers (Saint-Louis, Lariboisière, Beaujon, Bichat and Avicenne) linked to the NORDICAP network. If a suspect lesion of OGC is discovered during the gastroscopy, the endoscopist will perform at least 8 endoscopic biopsies, according to the recommendations, and by the mean of 2 kinds of forceps: standard biopsy forceps and a large capacity biopsy forceps. The clinical and follow-up data will be prospectively collected and will include demographics data, cancer stage, lymph node invasion, treatment history, recurrence and survival data. The investigators will assess MSI status by genotyping and MMR proteins expression by immunochemistry (IHC), performed, for each patient, on both biopsies and surgical tumor samples.
Expected results This study will allow us to compare diagnostic performance of endoscopic biopsies to surgical samples for the assessment of dMMR status. Likewise, the investigators will compare the diagnostic performance of the two kinds of endoscopic forceps and of IHC and genotyping for the determination of dMMR phenotype. It will enable us to establish recommendations for the benefit of gastro-enterologists and pathologists.
- Conditions
- Gastro-oesophageal Adenocarcinoma
- Being tested
- Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps, Order of forceps : First large capacity biopsy forceps and second standard biopsy forceps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Order of forceps : First standard biopsy forceps and second large capacity biopsy forcepsDevice
Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps
Order of forceps : First large capacity biopsy forceps and second standard biopsy forcepsDevice
Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps
| Study group | Role | What they receive |
|---|---|---|
| Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps | Other | Not described Receives: Device: Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps |
| Order of forceps : First large capacity biopsy forceps and second standard biopsy forceps | Other | Not described Receives: Device: Order of forceps : First large capacity biopsy forceps and second standard biopsy forceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity (Se) of the determination of the dMMR status by the endoscopic biopsies performed at the time of the initial high endoscopy
The sensitivity will be evaluated by comparing the endocospic result with that obtained by the analysis of the specimen considered as the reference examination.
Measured: at inclusion
Specificity (Spe) of the determination of the dMMR status by the endoscopic biopsies performed at the time of the initial high endoscopy
The specificity will be evaluated by comparing the endocospic result with that obtained by the analysis of the specimen considered as the reference examination.
Measured: at inclusion
Secondary outcomes (12)
Positive likelihood ratios
Measured: at inclusion
Negative likelihood ratios
Measured: at inclusion
Sensitivity of dMMR status diagnosis according to the forceps (standard and large capacity biopsy forceps )
Measured: at inclusion
Specificity of dMMR status diagnosis according to the forceps (standard and large capacity biopsy forceps )
Measured: at inclusion
Sensitivity of dMMR status diagnosis according to the techniques (immunohistochemistry and PCR)
Measured: at inclusion
Specificity of dMMR status diagnosis according to the techniques (immunohistochemistry and PCR)
Measured: at inclusion
Sensitivity of the diagnosis of MR status according to the location on the biopsies (esophagus, gastroesophageal junction, fundus, antrum)
Measured: at inclusion
Specificityof the diagnosis of MR status according to the location on the biopsies (esophagus, gastroesophageal junction, fundus, antrum)
Measured: at inclusion
Sensitivity of dMMR status diagnosis according to the number of techniques used (two techniques or one technique)
Measured: at inclusion
Specificity of dMMR status diagnosis according to the number of techniques used (two techniques or one technique)
Measured: at inclusion
Overall survival
Measured: up to 36 months
Survival without recurrence
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study startMar 2021 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-oesophageal AdenocarcinomaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
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
- NCT04774367
- Sponsor's protocol ID
- APHP180152
- Acronym
- BIOPSYGAST MMR
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Reliability of the Determination of MisMatch Repair Deficiency Status by Endoscopic Biopsies in Oesophagus and Gastric Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT04774367
- Acronym / sponsor ID
- BIOPSYGAST MMR / APHP180152
- Conditions
- Gastro-oesophageal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 1 Mar 2021 (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.
Gastro-esophageal adenocarcinoma is one of the most common cancer in the world and the fourth most common cancer in France with more than 6,000 cases per year. For non-metastatic patients, a preoperative chemotherapy is recommended.
As colorectal adenocarcinomas, gastroesophageal cancers (OGC) could be caused by a failure of DNA repair related to the loss of expression of one of the DNA repair proteins (MLH1, MSH2, PMS2, MSH6) (deficient MMR (dMMR)). The prevalence of tumors with dMMR is evaluated at 14% (Choi et al, 2014; Kim et al, 2015). This proportion reaches 25% among patients over 70 years old. Evidence suggests that patients with dMMR tumors do not benefit from neoadjuvant chemotherapy (Smyth et al, 2017), which may even have a negative impact, especially in elderly patients, and which should be discussed in this particular situation. The decision of neo-adjuvant chemotherapy must be taken very quickly after the endoscopic diagnosis.
The investigators will evaluate the diagnostic performance of the determination of dMMR status by endoscopic biopsies of OGC.
Moreover, there is no clear recommendation for the determination of dMMR status in OGC especially regarding the size of the forceps to use to ensure the quality of samples and the best molecular techniques for dMMR status determination.
Methods In this prospective study, the investigators will include patients who will benefit from an upper endoscopy within 5 French hospital centers (Saint-Louis, Lariboisière, Beaujon, Bichat and Avicenne) linked to the NORDICAP network. If a suspect lesion of OGC is discovered during the gastroscopy, the endoscopist will perform at least 8 endoscopic biopsies, according to the recommendations, and by the mean of 2 kinds of forceps: standard biopsy forceps and a large capacity biopsy forceps. The clinical and follow-up data will be prospectively collected and will include demographics data, cancer stage, lymph node invasion, treatment history, recurrence and survival data. The investigators will assess MSI status by genotyping and MMR proteins expression by immunochemistry (IHC), performed, for each patient, on both biopsies and surgical tumor samples.
Expected results This study will allow us to compare diagnostic performance of endoscopic biopsies to surgical samples for the assessment of dMMR status. Likewise, the investigators will compare the diagnostic performance of the two kinds of endoscopic forceps and of IHC and genotyping for the determination of dMMR phenotype. It will enable us to establish recommendations for the benefit of gastro-enterologists and pathologists.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps | Other | Device: Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps |
| Order of forceps : First large capacity biopsy forceps and second standard biopsy forceps | Other | Device: Order of forceps : First large capacity biopsy forceps and second standard biopsy forceps |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient having endoscopy biopsies in front of a suspicious lesion suggestive of gastroesophageal adenocarcinoma
Key exclusion criteria (4 listed)
- Minor patient (<18 years old)
- known pregnancy
- Major patient under tutorship or curatorship
- Contraindication to gastric biopsies
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 |
|---|---|---|
| Order of forceps : First standard biopsy forceps and second large capacity biopsy forcepsOrder of forceps : First standard biopsy forceps and second large capacity biopsy forceps | Device | Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps |
| Order of forceps : First large capacity biopsy forceps and second standard biopsy forcepsOrder of forceps : First standard biopsy forceps and second large capacity biopsy forceps | Device | Order of forceps : First large capacity biopsy forceps and second standard biopsy forceps |
Primary outcome
Sensitivity (Se) of the determination of the dMMR status by the endoscopic biopsies performed at the time of the initial high endoscopy
Time frame: at inclusion
The sensitivity will be evaluated by comparing the endocospic result with that obtained by the analysis of the specimen considered as the reference examination.
Specificity (Spe) of the determination of the dMMR status by the endoscopic biopsies performed at the time of the initial high endoscopy
Time frame: at inclusion
The specificity will be evaluated by comparing the endocospic result with that obtained by the analysis of the specimen considered as the reference examination.
12 secondary outcomes
Positive likelihood ratios
Time frame: at inclusion
Negative likelihood ratios
Time frame: at inclusion
Sensitivity of dMMR status diagnosis according to the forceps (standard and large capacity biopsy forceps )
Time frame: at inclusion
Specificity of dMMR status diagnosis according to the forceps (standard and large capacity biopsy forceps )
Time frame: at inclusion
Sensitivity of dMMR status diagnosis according to the techniques (immunohistochemistry and PCR)
Time frame: at inclusion
Specificity of dMMR status diagnosis according to the techniques (immunohistochemistry and PCR)
Time frame: at inclusion
Sensitivity of the diagnosis of MR status according to the location on the biopsies (esophagus, gastroesophageal junction, fundus, antrum)
Time frame: at inclusion
Specificityof the diagnosis of MR status according to the location on the biopsies (esophagus, gastroesophageal junction, fundus, antrum)
Time frame: at inclusion
Sensitivity of dMMR status diagnosis according to the number of techniques used (two techniques or one technique)
Time frame: at inclusion
Specificity of dMMR status diagnosis according to the number of techniques used (two techniques or one technique)
Time frame: at inclusion
Overall survival
Time frame: up to 36 months
Survival without recurrence
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps and Order of forceps : First large capacity biopsy forceps and second standard biopsy forceps in people with Gastro-oesophageal Adenocarcinoma, run by Assistance Publique - Hôpitaux de Paris.
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 1 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: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas APARICIO (+33142499597, thomas.aparicio@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (Se) of the determination of the dMMR status by the endoscopic biopsies performed at the time of the initial high endoscopy (time frame: at inclusion). The study lists 2 primary outcomes in all. 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 Mar 2021.