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

March 24, 2015 updated by: Roberto A. Pazo-Cid, Hospital Miguel Servet

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Roberto A. Pazo-Cid, MD
  • Phone Number: 1147 (+34) 976-765-500
  • Email: rapazocid@seom.org

Study Locations

  • Spain
      • Zaragoza, Spain, 50009
        • Recruiting
        • Medical oncology Department, Miguel Servet University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be adults with advanced or metastatic gastric cancer (AGC), candidates to receive a first-line systemic therapy, who meet all of the inclusion criteria and none of the exclusion criteria within 28 days prior to the first day of study treatment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Advanced gastric cancer patients
Treatment näive advanced gastric cancer patients candidates to first-line chemotherapy
Control group
Healthy adult volunteers without a cancer diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
• Characterization of the molecular profile in tumor derived exosomes from advanced gastric cancer patients undergoing first-line chemotherapy
Time Frame: Up to 2 years from start of study
Up to 2 years from start of study
• 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.
Time Frame: Up to 3 years from start of the study
Up to 3 years from start of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Miguel Servet

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

January 1, 2016

Study Registration Dates

First Submitted

January 26, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (ESTIMATE)

January 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXO-PPP study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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