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

NCT ID: NCT02491840

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2029-08-31

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

Conditions

Gastric and Cardia Adenocarcinomas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Gastric and cardia adenocarcinomas

Biopsy of Gastric and cardia adenocarcinomas

Group Type: EXPERIMENTAL

Biopsy

Intervention Type: PROCEDURE

Biopsy of Gastric and cardia adenocarcinomas

Interventions

Biopsy

Biopsy of Gastric and cardia adenocarcinomas

Intervention Type: PROCEDURE

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 ...)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benoît ROMAIN, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Strasbourg, France

Locations

University Hospital, Strasbourg, france

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Benoît ROMAIN, MD

Role: CONTACT

benoit.romain@chru-strasbourg.fr

03/88/12/72/43 ext. 0033

Facility Contacts

Benoit ROMAIN, MD

Role: primary

benoit.romain@chru-strasbourg.fr

Other Identifiers

6042

Identifier Type: -

Identifier Source: org_study_id