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

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ClinicalTrials.gov Identifier: NCT02491840
Recruitment Status : Recruiting
First Posted : July 8, 2015
Last Update Posted : July 8, 2022
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Gastric and Cardia Adenocarcinomas Procedure: Biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Biomoleculars Markers of Sensitivity to Pre- and Post-operative Chemotherapy of Gastric and Cardia Adenocarcinomas: a Pilot Study
Actual Study Start Date : May 2016
Estimated Primary Completion Date : July 2029
Estimated Study Completion Date : August 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Biopsy

Arm Intervention/treatment
Experimental: Gastric and cardia adenocarcinomas
Biopsy of Gastric and cardia adenocarcinomas
Procedure: Biopsy
Biopsy of Gastric and cardia adenocarcinomas




Primary Outcome Measures :
  1. Assessment of expression level of Met [ Time Frame: 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

  2. Assessment of expression level of Her2 [ Time Frame: 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

  3. Assessment of expression level of FGFR2 [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491840


Contacts
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Contact: Benoît ROMAIN, MD 03/88/12/72/43 ext 0033 benoit.romain@chru-strasbourg.fr

Locations
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France
University Hospital, Strasbourg, france Recruiting
Strasbourg, France, 67000
Contact: Benoit ROMAIN, MD       benoit.romain@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Benoît ROMAIN, MD University Hospital, Strasbourg, France
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02491840    
Other Study ID Numbers: 6042
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: July 8, 2022
Last Verified: July 2022
Keywords provided by University Hospital, Strasbourg, France:
gastric cancer
cardia cancer
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms