Circulating Exosomes As Potential Prognostic And Predictive Biomarkers In Advanced Gastric Cancer Patients ("EXO-PPP Study")
EXO-PPP
1 other identifier
observational
80
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 26, 2013
CompletedFirst Posted
Study publicly available on registry
January 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedMarch 25, 2015
March 1, 2015
3 years
January 26, 2013
March 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
• 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
• 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
Study Arms (2)
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 Criteria
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.
You may qualify if:
- Subjects eligible for enrollment must meet all of the following criteria:
- 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
- Men or women aged \>= 18 years.
- Eastern Cooperative Oncology Group Performance Status (ECOG) \<= 2.
- Histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction or esophagus.
- Metastatic disease or locally advanced disease not amenable to curative surgery.
- Radiographically assessable, non-measurable disease or measurable disease as per RECIST criteria.
- Life expectancy of at least 12 weeks from the time of enrollment.
- 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.
- No prior chemotherapy for advanced disease.
You may not qualify if:
- Subjects meeting any of the following criteria must not be enrolled in the study:
- Gastric carcinoid, sarcomas, or squamous cell cancer.
- Pregnant or lactating females.
- Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent.
- Active Hepatitis B or C or history of an HIV infection.
- Active uncontrolled infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical oncology Department, Miguel Servet University Hospital
Zaragoza, Spain, 50009, Spain
Related Publications (1)
Peinado H, Aleckovic M, Lavotshkin S, Matei I, Costa-Silva B, Moreno-Bueno G, Hergueta-Redondo M, Williams C, Garcia-Santos G, Ghajar C, Nitadori-Hoshino A, Hoffman C, Badal K, Garcia BA, Callahan MK, Yuan J, Martins VR, Skog J, Kaplan RN, Brady MS, Wolchok JD, Chapman PB, Kang Y, Bromberg J, Lyden D. Melanoma exosomes educate bone marrow progenitor cells toward a pro-metastatic phenotype through MET. Nat Med. 2012 Jun;18(6):883-91. doi: 10.1038/nm.2753.
PMID: 22635005BACKGROUND
Related Links
Biospecimen
* Serum * Tumor tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 26, 2013
First Posted
January 30, 2013
Study Start
January 1, 2013
Primary Completion
January 1, 2016
Last Updated
March 25, 2015
Record last verified: 2015-03