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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01779583
Recruitment Status : Unknown
Verified March 2015 by Roberto A. Pazo-Cid, Hospital Miguel Servet.
Recruitment status was:  Recruiting
First Posted : January 30, 2013
Last Update Posted : March 25, 2015
Centro Nacional de Investigaciones Oncologicas CARLOS III
Aragon Institute of Health Sciences
Information provided by (Responsible Party):
Roberto A. Pazo-Cid, Hospital Miguel Servet

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
Gastric Cancer

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Study Type : Observational
Estimated 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 : January 2013
Estimated Primary Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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

Primary Outcome Measures :
  1. • 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 ]
  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. [ Time Frame: Up to 3 years from start of the study ]

Biospecimen Retention:   Samples With DNA
  • Serum
  • Tumor tissue

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01779583

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Contact: Roberto A. Pazo-Cid, MD (+34) 976-765-500 ext 1147

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Medical oncology Department, Miguel Servet University Hospital Recruiting
Zaragoza, Spain, 50009
Contact: ROBERTO A PAZO-CID, MD    (+34) 976-765-500 ext 1147   
Sponsors and Collaborators
Hospital Miguel Servet
Centro Nacional de Investigaciones Oncologicas CARLOS III
Aragon Institute of Health Sciences
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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
Additional Information:
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Responsible Party: Roberto A. Pazo-Cid, MD, Hospital Miguel Servet Identifier: NCT01779583    
Other Study ID Numbers: EXO-PPP study
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015
Keywords provided by Roberto A. Pazo-Cid, Hospital Miguel Servet:
Advanced gastric cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases