Circulating Exosomes As Potential Prognostic And Predictive Biomarkers In Advanced Gastric Cancer Patients ("EXO-PPP Study")
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Purpose
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 |
|---|
|
Gastric Cancer |
| Study Type: | Observational |
| Study Design: | 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") |
- • 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 ] [ Designated as safety issue: No ]
- • 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
- Serum
- Tumor tissue
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2013 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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:
- 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.
Exclusion Criteria:
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.
Contacts and Locations| Contact: Roberto A. Pazo-Cid, MD | (+34) 976-765-500 ext 1147 | rapazocid@seom.org |
| Spain | |
| Medical oncology Department, Miguel Servet University Hospital | Recruiting |
| Zaragoza, Spain, 50009 | |
| Contact: ROBERTO A PAZO-CID, MD (+34) 976-765-500 ext 1147 rapazocid@seom.org | |
| Principal Investigator: | HECTOR PEINADO, PhD | Spanish National Cancer Research Centre (CNIO) |
| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | Roberto A. Pazo-Cid, MD, Hospital Miguel Servet |
| ClinicalTrials.gov Identifier: | NCT01779583 History of Changes |
| Other Study ID Numbers: | EXO-PPP study |
| Study First Received: | January 26, 2013 |
| Last Updated: | March 13, 2013 |
| Health Authority: | Spain: Spanish National Health Institute - Spanish Ministry of Health, Social Services and Equality |
Keywords provided by Hospital Miguel Servet:
|
Advanced gastric cancer |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
ClinicalTrials.gov processed this record on June 18, 2013