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NCT Number: NCT02491840

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

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

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Key information

Conditions

Gastric and Cardia Adenocarcinomas Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Strasbourg, france

Strasbourg, 67000, France

Location status: Recruiting

Location contact

Benoit ROMAIN, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ...)

Treatment and study plan

Biopsy

Procedure

Biopsy of Gastric and cardia adenocarcinomas

Primary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Benoît ROMAIN, MD

CONTACT

[email protected]

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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Important dates

Study start
2016
Primary completion
2029
Study completion
2029
First posted
Jul 8, 2015
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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