- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07787052
R-GASTIM- Study of Gastric Cancer Operable (R-GASTIM)
August 24, 2026 updated by: Centre Leon Berard
R-GASTIM - Clinicobiological Cohort of Gastric Cancers
Clinicobiological cohort of gastric cancers operated in our institution.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Study of microenvironment of gastric cancers using tumor and lymph nodes, collected as per standard of care.
Analysis by RNASeq and HyperIon
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clélia coutzac, MD,PhD
- Phone Number: 0033478782828
- Email: clelia.coutzac@lyon.unicancer.fr
Study Locations
-
-
-
Lyon, France, 69008
- Recruiting
- Centre Leon Berard
-
Contact:
- Clélia coutzac, MD,PhD
- Phone Number: 0033478782828
- Email: clelia.coutzac@lyon.unicancer.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients with non-metastatic resectable gastric and gastroesophageal junction adenocarcinoma, Stage IB to III treated with standard neoadjuvant chemotherapy, operated at Centre léon Bérard, with available tumor and lymph nodes samples
Description
Inclusion Criteria:
- Adult patients with histologically proven non-metastatic resectable gastric and gastroesophageal junction adenocarcinoma, Stage IB to III be treated with standard neoadjuvant chemotherapy
- Knwon response to neoadjuvant chemotherapy as per TRG criteria
- Surgery of primary tumor done at Centre Léon Bérard. Availability of archival FFPE tumor block from initial diagnosis with at least 20% of tumor cells and collected lymp nodes
Exclusion Criteria:
- Patient refusal to participate to this clinicobiological cohort
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gene expression
Time Frame: surgery
|
Transcriptom of Surgery and lymp node specimen
|
surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HyperIon
Time Frame: surgery
|
Hyperion data on surgery and lymph nodes sample
|
surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2024
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2027
Study Registration Dates
First Submitted
September 30, 2024
First Submitted That Met QC Criteria
August 24, 2026
First Posted (Actual)
August 26, 2026
Study Record Updates
Last Update Posted (Actual)
August 26, 2026
Last Update Submitted That Met QC Criteria
August 24, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R201-004-117 (Registry Identifier: MR04 on site)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.