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

This study is currently recruiting participants.
Verified January 2014 by Hospital Miguel Servet
Sponsor:
Collaborators:
Centro Nacional de Investigaciones Oncologicas CARLOS III
Aragon Institute of Health Sciences
Information provided by (Responsible Party):
Roberto A. Pazo-Cid, Hospital Miguel Servet
ClinicalTrials.gov Identifier:
NCT01779583
First received: January 26, 2013
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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
Gastric Cancer

Study Type: Observational
Study Design: 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")

Resource links provided by NLM:


Further study details as provided by Hospital Miguel Servet:

Primary Outcome Measures:
  • • 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 ] [ Designated as safety issue: No ]
  • • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
  • Serum
  • Tumor tissue

Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Advanced gastric cancer patients
Treatment näive advanced gastric cancer patients candidates to first-line chemotherapy
Control group
Healthy adult volunteers without a cancer diagnosis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779583

Contacts
Contact: Roberto A. Pazo-Cid, MD (+34) 976-765-500 ext 1147 rapazocid@seom.org

Locations
Spain
Medical oncology Department, Miguel Servet University Hospital Recruiting
Zaragoza, Spain, 50009
Contact: ROBERTO A PAZO-CID, MD    (+34) 976-765-500 ext 1147    rapazocid@seom.org   
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
  More Information

Additional Information:
Publications:
Responsible Party: Roberto A. Pazo-Cid, MD, Hospital Miguel Servet
ClinicalTrials.gov Identifier: NCT01779583     History of Changes
Other Study ID Numbers: EXO-PPP study
Study First Received: January 26, 2013
Last Updated: January 21, 2014
Health Authority: Spain: Spanish National Health Institute - Spanish Ministry of Health, Social Services and Equality

Keywords provided by Hospital Miguel Servet:
Advanced gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on April 17, 2014