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Circulating Exosomes As Potential Prognostic And Predictive Biomarkers In Advanced Gastric Cancer Patients ("EXO-PPP Study")

Sponsor
Hospital Miguel Servet (Other)
Overall Status
Unknown status
CT.gov ID
NCT01779583
Collaborator
Centro Nacional de Investigaciones Oncologicas CARLOS III (Other), Aragon Institute of Health Sciences (Other)
80
Enrollment
1
Location

Study Details

Study Description

Brief Summary

Exosomes are formed by inward budding of late endosomes, producing multivesicular bodies (MVBs), and are released into the environment by fusion of the MVBs with the plasma membrane. It has been demonstrated that the content and function of exosomes depends on the originating cell and the conditions under which they are produced. Tumor exosome production, transfer and education of bone marrow cells supports tumor growth and metastasis.

In this prospective translational study, preclinical and clinical phases have been designed. On the first step, the main goal is to characterize the molecular profile of gastric cancer derived exosomes. This exosome biosignature may provide a useful diagnostic tool. As a second step, the study will evaluate the prognostic and predictive value of gastric cancer exosomes levels in plasma and kinetics in a prospectively recruited cohort of advanced gastric cancer patients during first-line chemotherapy.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Circulating Exosomes As Potential Prognostic And Predictive Biomarkers In Advanced Gastric Cancer Patients: A Prospective Observational Study ("EXO-PPP Study")
    Study Start Date :
    Jan 1, 2013
    Anticipated Primary Completion Date :
    Jan 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Advanced gastric cancer patients

    Treatment näive advanced gastric cancer patients candidates to first-line chemotherapy
    Control group

    Healthy adult volunteers without a cancer diagnosis

    Outcome Measures

    Primary Outcome Measures

    1. • Characterization of the molecular profile in tumor derived exosomes from advanced gastric cancer patients undergoing first-line chemotherapy [Up to 2 years from start of study]

    2. • Correlation of plasma level and kinetics of gastric cancer derived exosomes (at baseline and monthly during therapy until tumor progression or death) and time-to-event end-points: Overall survival, Progression-free survival and Overall response rate. [Up to 3 years from start of the study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    Subjects eligible for enrollment must meet all of the following criteria:

    1. Provide signed informed consent. The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent, approved by the Independent Ethic Committee (IEC)/Institutional Review Board (IRB) prior to the initiation of any study-specific procedures

    2. Men or women aged >= 18 years.

    3. Eastern Cooperative Oncology Group Performance Status (ECOG) <= 2.

    4. Histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction or esophagus.

    5. Metastatic disease or locally advanced disease not amenable to curative surgery.

    6. Radiographically assessable, non-measurable disease or measurable disease as per RECIST criteria.

    7. Life expectancy of at least 12 weeks from the time of enrollment.

    8. No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.

    9. No prior chemotherapy for advanced disease.

    Exclusion Criteria:
    Subjects meeting any of the following criteria must not be enrolled in the study:

    1. Gastric carcinoid, sarcomas, or squamous cell cancer.

    2. Pregnant or lactating females.

    3. Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent.

    4. Active Hepatitis B or C or history of an HIV infection.

    5. Active uncontrolled infection.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical oncology Department, Miguel Servet University Hospital Zaragoza Spain 50009

    Sponsors and Collaborators

    • Hospital Miguel Servet
    • Centro Nacional de Investigaciones Oncologicas CARLOS III
    • Aragon Institute of Health Sciences

    Investigators

    • Principal Investigator: HECTOR PEINADO, PhD, Weill Medical College of Cornell University
    • Study Chair: PILAR MARTIN-DUQUE, PhD, Francisco de Vitoria´s University - Aragon Institute of Health Sciences
    • Study Director: ROBERTO A PAZO-CID, MD, Aragon Institute of Health Sciences - Medical Oncology Department, Miguel Servet University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Roberto A. Pazo-Cid, MD, Hospital Miguel Servet
    ClinicalTrials.gov Identifier:
    NCT01779583
    Other Study ID Numbers:
    • EXO-PPP study
    First Posted:
    Jan 30, 2013
    Last Update Posted:
    Mar 25, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by Roberto A. Pazo-Cid, MD, Hospital Miguel Servet
    Advanced gastric cancer
    Additional relevant MeSH terms:
    Stomach Neoplasms

    Study Results

    No Results Posted as of Mar 25, 2015