Gastric CancerEXO-PPPNCT01779583
Circulating Exosomes As Potential Prognostic And Predictive Biomarkers In Advanced Gastric Cancer Patients ("EXO-PPP Study")
An observational study of Gastric Cancer, run by Hospital Miguel Servet at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Medical oncology Department, Miguel Servet University Hospital
Zaragoza, Spain, 50009
ROBERTO A PAZO-CID, MD, (+34) 976-765-500 ext. 1147, rapazocid@seom.org
About this study
Official title: Circulating Exosomes As Potential Prognostic And Predictive Biomarkers In Advanced Gastric Cancer Patients: A Prospective Observational Study ("EXO-PPP Study")
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
- Keywords
- Advanced gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Advanced gastric cancer patients | Treatment näive advanced gastric cancer patients candidates to first-line chemotherapy | |
| Control group | Healthy adult volunteers without a cancer diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Characterization of the molecular profile in tumor derived exosomes from advanced gastric cancer patients undergoing first-line chemotherapy
Measured: 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.
Measured: Up to 3 years from start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Nacional de Investigaciones Oncologicas CARLOS III, Aragon Institute of Health Sciences
- Responsible party
- Principal investigator, Roberto A. Pazo-Cid, Hospital Miguel Servet
- Investigators
- HECTOR PEINADO, PhD, Principal investigator, Weill Medical College of Cornell UniversityPILAR MARTIN-DUQUE, PhD, Study chair, Francisco de Vitoria´s University - Aragon Institute of Health SciencesROBERTO A PAZO-CID, MD, Study director, Aragon Institute of Health Sciences - Medical Oncology Department, Miguel Servet University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779583
- Sponsor's protocol ID
- EXO-PPP study
- Acronym
- EXO-PPP
- Status last verified
- Mar 2015
- First submitted
- 26 Jan 2013
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22635005
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Exosomes As Potential Prognostic And Predictive Biomarkers In Advanced Gastric Cancer Patients: A Prospective Observational Study ("EXO-PPP Study")
- ClinicalTrials.gov ID
- NCT01779583
- Acronym / sponsor ID
- EXO-PPP / EXO-PPP study
- Conditions
- Gastric Cancer
- Keywords
- Advanced gastric cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital Miguel ServetUniversity, hospital or other
- Collaborators
- Centro Nacional de Investigaciones Oncologicas CARLOS III, Aragon Institute of Health Sciences
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (estimated)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced gastric cancer patients | – | –Treatment näive advanced gastric cancer patients candidates to first-line chemotherapy |
| Control group | – | –Healthy adult volunteers without a cancer diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Background: PubMed 22635005Peinado 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.
- Miguel Servet University Hospital, Zaragoza, SpainLink provided by the sponsor.
- Francisco de Vitorias´s University (Madrid)Link provided by the sponsor.
- Weill Cornell Medical CollegeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HECTOR PEINADO, PhD principal investigator
Weill Medical College of Cornell University
PILAR MARTIN-DUQUE, PhD study chair
Francisco de Vitoria´s University - Aragon Institute of Health Sciences
ROBERTO A PAZO-CID, MD study director
Aragon Institute of Health Sciences - Medical Oncology Department, Miguel Servet University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Hospital Miguel Servet at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto A. Pazo-Cid, MD ((+34) 976-765-500 ext. 1147, rapazocid@seom.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01779583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015; AzTrials last refreshed its copy on 31 Oct 2026.