Circulating Exosomes As Potential Prognostic And Predictive Biomarkers In Advanced Gastric Cancer Patients ("EXO-PPP Study") (EXO-PPP)
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|ClinicalTrials.gov 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
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|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Observational Model:||Case Control|
|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|
Advanced gastric cancer patients
Treatment näive advanced gastric cancer patients candidates to first-line chemotherapy
Healthy adult volunteers without a cancer diagnosis
- • 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 ]
- • 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
- Tumor tissue
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 ClinicalTrials.gov identifier (NCT number): NCT01779583
|Contact: Roberto A. Pazo-Cid, MD||(+34) 976-765-500 ext firstname.lastname@example.org|
|Medical oncology Department, Miguel Servet University Hospital||Recruiting|
|Zaragoza, Spain, 50009|
|Contact: ROBERTO A PAZO-CID, MD (+34) 976-765-500 ext 1147 email@example.com|
|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|