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

Gastric Cancer Clinical Trial

— EXO-PPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01779583
• Other study ID #: EXO-PPP study
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2013
• Last updated: March 24, 2015
• Start date: January 2013

Study information

• Verified date: March 2015
• Source: Hospital Miguel Servet
• Contact: Roberto A. Pazo-Cid, MD
• Phone: (+34) 976-765-500
• Email: rapazocid[@]seom.org
• Is FDA regulated: No
• Health authority: Spain: Spanish National Health Institute - Spanish Ministry of Health, Social Services and Equality
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
Spain	Medical oncology Department, Miguel Servet University Hospital	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Miguel Servet	Aragon Institute of Health Sciences, Centro Nacional de Investigaciones Oncologicas CARLOS III

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Peinado H, Aleckovic M, Lavotshkin S, Matei I, Costa-Silva B, Moreno-Bueno G, Hergueta-Redondo M, Williams C, García-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	No
Primary	• 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	No

External Links

•   Aragon Institute of Health Sciences, Zaragoza, Spain
•   Francisco de Vitorias´s University (Madrid)
•   Miguel Servet University Hospital, Zaragoza, Spain
•   Weill Cornell Medical College