Gastric CancerNCT05013775
The Diagnostic Value of Staging Laparoscopy and Computed Tomography Response Assessment in Patients With Gastric Adenocarcinoma
An observational study of Gastric Cancer, run by Sander van Hootegem at 1 site in Netherlands.
Trial summary
SUMMARY Rationale: Diagnostic laparoscopy (DL) and response assessment after neoadjuvant chemotherapy with computed tomography (CT) are two diagnostic modalities used to assess metastatic spread in gastric cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Computed tomography and Diagnostic laparoscopy with peritoneal lavage
- How many people
- 697 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Jan 2019to 12 May 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients with gastric and gastro-oesophageal adenocarcinoma who presented or were referred to one of the participating centres and have been discussed at multidisciplinary team meetings (MDT) for curative management from January 2016 through December 2018. The University Medical Center of the Johannes Gutenberg University Mainz will only contribute with data on DL and not on patients who underwent CT response assessment.
Who may be able to join
- Patients with histologically proven gastric and esophagogastric junction adenocarcinoma.
- Patients who have had (either) DLS and/or CT response assessment (after chemotherapy).
- Discussed at MDT from January 2016 - December 2018
- ≥18 years
Who cannot join
- Patients with esophagogastric junction adenocarcinoma with the tumour bulk located in the oesophagus that receive neoadjuvant chemoradiation;
- Patients with recurrent/residual disease after earlier treatment of gastric cancer.
Trial locations and contacts
1 site in 1 country.
About this study
SUMMARY
Rationale: Diagnostic laparoscopy (DL) and response assessment after neoadjuvant chemotherapy with computed tomography (CT) are two diagnostic modalities used to assess metastatic spread in gastric cancer patients. It is still unclear in what proportion of patients clinically relevant metastases or other significant findings (e.g. contra-indications of surgery) are detected that impact on the treatment.
Read more
Objective: To determine the clinical value of diagnostic laparoscopy and computed tomography response assessment after neoadjuvant chemotherapy in patients with gastric and esophagogastric junction adenocarcinoma.
Study design: Multicentre retrospective cohort study.
Study population: All Patients with gastric and gastro-oesophageal adenocarcinoma who underwent clinical staging and were discussed at multidisciplinary team meetings (MDT) between January 2016 and December 2018.
Intervention (if applicable): Not applicable.
Main study parameters/endpoints: The main study parameter is the proportion (%) of patients who do not proceed with treatment as planned after a DL and CT response assessment (i.e. the proportion of patients in which metastasized disease or other contra-indications for surgery is found).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since this is an observational study, no burden or risks are associated with participation.
- Conditions
- Gastric Cancer
- Being tested
- Computed tomography, Diagnostic laparoscopy with peritoneal lavage
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomographyDiagnostic test
Computed tomography to gauge response after preoperative chemotherapy cycles and excluded the development of interval metastases or irresectable disease
Diagnostic laparoscopy with peritoneal lavageDiagnostic test
Diagnostic laparoscopy lavage to exclude (small-volume) metastases and determine local resectability
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in treatment
Proportion of patients in which the diagnostic test led to change in treatment/management
Measured: 1 month (on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start15 Jan 2019
- Primary completion22 Aug 2020
- Study completion12 May 2021
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.
- 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
- Retrospective
- Enrolment
- 697 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sander van Hootegem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sander van Hootegem, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013775
- Sponsor's protocol ID
- MEC-2019-0284
- Status last verified
- Aug 2021
- First submitted
- 14 Aug 2021
- Last updated
- 19 Aug 2021
- Results posted
- 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 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of Staging Laparoscopy and Computed Tomography Response Assessment in Patients With Gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05013775
- Acronym / sponsor ID
- MEC-2019-0284
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 697 participants (actual)
- Lead sponsor
- Sander van HootegemUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 22 Aug 2020 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 19 Aug 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.
SUMMARY
Rationale: Diagnostic laparoscopy (DL) and response assessment after neoadjuvant chemotherapy with computed tomography (CT) are two diagnostic modalities used to assess metastatic spread in gastric cancer patients. It is still unclear in what proportion of patients clinically relevant metastases or other significant findings (e.g. contra-indications of surgery) are detected that impact on the treatment.
Objective: To determine the clinical value of diagnostic laparoscopy and computed tomography response assessment after neoadjuvant chemotherapy in patients with gastric and esophagogastric junction adenocarcinoma.
Study design: Multicentre retrospective cohort study.
Study population: All Patients with gastric and gastro-oesophageal adenocarcinoma who underwent clinical staging and were discussed at multidisciplinary team meetings (MDT) between January 2016 and December 2018.
Intervention (if applicable): Not applicable.
Main study parameters/endpoints: The main study parameter is the proportion (%) of patients who do not proceed with treatment as planned after a DL and CT response assessment (i.e. the proportion of patients in which metastasized disease or other contra-indications for surgery is found).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since this is an observational study, no burden or risks are associated with participation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with gastric and gastro-oesophageal adenocarcinoma who presented or were referred to one of the participating centres and have been discussed at multidisciplinary team meetings (MDT) for curative management from January 2016 through December 2018. The University Medical Center of the Johannes Gutenberg University Mainz will only contribute with data on DL and not on patients who underwent CT response assessment.
Key inclusion criteria (4 listed)
- Patients with histologically proven gastric and esophagogastric junction adenocarcinoma.
- Patients who have had (either) DLS and/or CT response assessment (after chemotherapy).
- Discussed at MDT from January 2016 - December 2018
- ≥18 years
Key exclusion criteria (2 listed)
- Patients with esophagogastric junction adenocarcinoma with the tumour bulk located in the oesophagus that receive neoadjuvant chemoradiation;
- Patients with recurrent/residual disease after earlier treatment of gastric cancer.
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 |
|---|---|---|
| Computed tomographyComputed tomography to gauge response after preoperative chemotherapy cycles and excluded the development of interval metastases or irresectable disease | Diagnostic test | – |
| Diagnostic laparoscopy with peritoneal lavageDiagnostic laparoscopy lavage to exclude (small-volume) metastases and determine local resectability | Diagnostic test | – |
Primary outcome
Change in treatment
Time frame: 1 month (on average)
Proportion of patients in which the diagnostic test led to change in treatment/management
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 19 Aug 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Gastric Cancer
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
Active, not recruitingPhase 2
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
RecruitingPhase 4
Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)
Gastrointestinal Cancer, Gastric Cancer
RecruitingObservational study
Development and Utilization of an Integrated Clinical Genomic Database
Gastric Cancer, Colorectal 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?
An observational study of Gastric Cancer, run by Sander van Hootegem 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 4 inclusion and 2 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 19 Aug 2021. 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 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?
Change in treatment (time frame: 1 month (on average)). 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 19 Aug 2021.