Biomoleculars Markers of Sensitivity to Pre- and Post-operative Chemotherapy of Gastric and Cardia Adenocarcinomas: a Pilot Study

Not Applicable

Recruiting

• Conditions: Gastric and Cardia Adenocarcinomas
• Interventions: Procedure: Biopsy

• Registration Number: NCT02491840
• Lead Sponsor: University Hospital, Strasbourg, France

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-07-02
• Study First Posted: 2015-07-08
• Study Start: 2016-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29
• Primary Completion: 2029-07
• Study Completion: 2029-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 ...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gastric and cardia adenocarcinomas	Biopsy	Biopsy of Gastric and cardia adenocarcinomas

Primary Outcome Measures

Name	Time	Method
Assessment of expression level of FGFR2	at 15 days	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 Met	at 15 days	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	at 15 days	To search in gastric and cardia tumors molecular markers of sensitivity to pre- and post-operative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation

Trial Locations

Locations (1)

University Hospital, Strasbourg, france; 🇫🇷 Strasbourg, France