Biomoleculars Markers of Sensitivity to Pre- and Post-operative Chemotherapy of Gastric and Cardia Adenocarcinomas: a Pilot Study
Primary Purpose
Gastric and Cardia Adenocarcinomas
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biopsy
Sponsored by
About this trial
This is an interventional basic science trial for Gastric and Cardia Adenocarcinomas focused on measuring gastric cancer, cardia cancer
Eligibility Criteria
Inclusion Criteria:
Gastric adenocarcinoma (any location) or cardia adenocarcinoma
- Age> 18 years
- WHO Index≤ 3
- Subject having signed an informed consent
Exclusion Criteria:
- Other cancers undergoing chemotherapy treatment
- Pregnant or breastfeeding
- Inability to understand information (understanding with difficulties ...)
Sites / Locations
- University Hospital, Strasbourg, franceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gastric and cardia adenocarcinomas
Arm Description
Biopsy of Gastric and cardia adenocarcinomas
Outcomes
Primary Outcome Measures
Assessment of expression level of Met
To search in gastric and cardia tumors molecular markers of sensitivity to pre- and post-operative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation
Assessment of expression level of Her2
To search in gastric and cardia tumors molecular markers of sensitivity to pre- and post-operative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation
Assessment of expression level of FGFR2
To search in gastric and cardia tumors molecular markers of sensitivity to pre- and post-operative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation
Secondary Outcome Measures
Full Information
NCT ID
NCT02491840
First Posted
June 23, 2015
Last Updated
August 10, 2023
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT02491840
Brief Title
Biomoleculars Markers of Sensitivity to Pre- and Post-operative Chemotherapy of Gastric and Cardia Adenocarcinomas: a Pilot Study
Official Title
Biomoleculars Markers of Sensitivity to Pre- and Post-operative Chemotherapy of Gastric and Cardia Adenocarcinomas: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2016 (Actual)
Primary Completion Date
July 2029 (Anticipated)
Study Completion Date
August 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Some subtypes of gastric and cardia tumors such as adenocarcinoma or gastric linitis with disseminated cells respond poorly to the pre-operative chemotherapy, and some of them do not respond to chemotherapy usually performed. Doing chemotherapy in these patients could delay their surgical management. The completion of chemotherapy for these patients would be a bad prognosis factor according to recent data from the literature. Therefore, the aim of this research is to find prognostic markers of sensitivity to chemotherapy usually performed. The investigators are going to use biopsies realized at diagnosis and select patients "good and bad" responders.
Primary purpose:
To study cardia and gastric tumors, molecular markers sensitivity to pre- and post- perative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation
Secondary purposes:
To assess the impact of patients' lifestyle (via a questionnaire) on the response to chemotherapy
To study markers of cancer stem cells
To correlate clinical and molecular markers with patient survival and quality of life questionnaires
To characterize the expression levels (Met, Her2, FGFR2) and mutations (p53 ras) in frequently deregulated genes in gastric cancers.
To characterize the level of expression of predictive candidate markers (ΔNp73, TAp73, HDAC4, mir140, EZH2, CXCL12, CXCR4, CXCR7) found in the literature.
To correlate the abnormalities found in the with tumor stages (before and after chemotherapy) and with 5 years overall survival and progression-free patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric and Cardia Adenocarcinomas
Keywords
gastric cancer, cardia cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gastric and cardia adenocarcinomas
Arm Type
Experimental
Arm Description
Biopsy of Gastric and cardia adenocarcinomas
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Intervention Description
Biopsy of Gastric and cardia adenocarcinomas
Primary Outcome Measure Information:
Title
Assessment of expression level of Met
Description
To search in gastric and cardia tumors molecular markers of sensitivity to pre- and post-operative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation
Time Frame
at 15 days
Title
Assessment of expression level of Her2
Description
To search in gastric and cardia tumors molecular markers of sensitivity to pre- and post-operative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation
Time Frame
at 15 days
Title
Assessment of expression level of FGFR2
Description
To search in gastric and cardia tumors molecular markers of sensitivity to pre- and post-operative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation
Time Frame
at 15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gastric adenocarcinoma (any location) or cardia adenocarcinoma
Age> 18 years
WHO Index≤ 3
Subject having signed an informed consent
Exclusion Criteria:
Other cancers undergoing chemotherapy treatment
Pregnant or breastfeeding
Inability to understand information (understanding with difficulties ...)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benoît ROMAIN, MD
Phone
03/88/12/72/43
Ext
0033
Email
benoit.romain@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoît ROMAIN, MD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Strasbourg, france
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit ROMAIN, MD
Email
benoit.romain@chru-strasbourg.fr
12. IPD Sharing Statement
Learn more about this trial
Biomoleculars Markers of Sensitivity to Pre- and Post-operative Chemotherapy of Gastric and Cardia Adenocarcinomas: a Pilot Study
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