NCT02491840

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
39mo left

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
May 2016Aug 2029

First Submitted

Initial submission to the registry

June 23, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
13.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

13.2 years

First QC Date

June 23, 2015

Last Update Submit

August 4, 2025

Conditions

Gastric and Cardia Adenocarcinomas

Keywords

gastric cancercardia cancer

Outcome Measures

Primary Outcomes (3)

  • 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

    at 15 days

  • 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

    at 15 days

  • 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

    at 15 days

Study Arms (1)

Gastric and cardia adenocarcinomas

EXPERIMENTAL

Biopsy of Gastric and cardia adenocarcinomas

Procedure: Biopsy

Interventions

BiopsyPROCEDURE

Biopsy of Gastric and cardia adenocarcinomas

Gastric and cardia adenocarcinomas

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gastric adenocarcinoma (any location) or cardia adenocarcinoma
  • Age\> 18 years
  • WHO Index≤ 3
  • Subject having signed an informed consent

You may not qualify if:

  • Other cancers undergoing chemotherapy treatment
  • Pregnant or breastfeeding
  • Inability to understand information (understanding with difficulties ...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Strasbourg, france

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Benoît ROMAIN, MD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benoît ROMAIN, MD

CONTACT

03/88/12/72/43benoit.romain@chru-strasbourg.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2015

First Posted

July 8, 2015

Study Start

May 1, 2016

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

August 8, 2025

Record last verified: 2025-08

Locations

FR(1)