Biomoleculars Markers of Sensitivity to Pre- and Post-operative Chemotherapy of Gastric and Cardia Adenocarcinomas: a Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biopsy.
- Who it may be relevant to
- Registry conditions: Gastric and Cardia Adenocarcinomas. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Procedure Biopsy
Biopsy of Gastric and cardia adenocarcinomas
Primary outcome measures
- Assessment of expression level of Met [Time frame: at 15 days]
- Assessment of expression level of Her2 [Time frame: at 15 days]
- Assessment of expression level of FGFR2 [Time frame: at 15 days]
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 ...)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- University Hospital, Strasbourg, france — Strasbourg
Identifiers
NCT: NCT02491840 · 6042