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

NCT ID: NCT01779583

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31

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.

Conditions

Gastric Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Advanced gastric cancer patients

Treatment näive advanced gastric cancer patients candidates to first-line chemotherapy

No interventions assigned to this group

Control group

Healthy adult volunteers without a cancer diagnosis

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro Nacional de Investigaciones Oncologicas CARLOS III

OTHER

Sponsor Role: collaborator

Aragon Institute of Health Sciences

OTHER

Sponsor Role: collaborator

Hospital Miguel Servet

OTHER

Sponsor Role: lead

Responsible Party

Roberto A. Pazo-Cid

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

HECTOR PEINADO, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

PILAR MARTIN-DUQUE, PhD

Role: STUDY_CHAIR

Francisco de Vitoria´s University - Aragon Institute of Health Sciences

ROBERTO A PAZO-CID, MD

Role: STUDY_DIRECTOR

Aragon Institute of Health Sciences - Medical Oncology Department, Miguel Servet University Hospital

Locations

Medical oncology Department, Miguel Servet University Hospital

Zaragoza, Spain, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Roberto A. Pazo-Cid, MD

Role: CONTACT

rapazocid@seom.org

(+34) 976-765-500 ext. 1147

Facility Contacts

ROBERTO A PAZO-CID, MD

Role: primary

rapazocid@seom.org

(+34) 976-765-500 ext. 1147

References

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.

Reference Type: BACKGROUND

PMID: 22635005 (View on PubMed)

Related Links

https://maps.google.es/maps?hl=en&q=hospital+miguel+servet+de+zaragoza&bav=on.2,or.r_gc.r_pw.r_cp.r_qf.&bvm=bv.41524429,d.cGE&biw=1067&bih=533&pdl=300&um=1&ie=UTF-8&sa=N&tab=wl

Miguel Servet University Hospital, Zaragoza, Spain

http://www.ufv.es

Francisco de Vitorias´s University (Madrid)

http://weill.cornell.edu/

Weill Cornell Medical College

Other Identifiers

EXO-PPP study

Identifier Type: -

Identifier Source: org_study_id