Colorectal CancerNCT02029326
Biomarker Analysis in Metastatic Colorectal Cancer Treated With Cetuximab
An observational study of Colorectal Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Prometheus's Onco dX assay platform provides technological breakthrough for immunoassay by obtaining a level of sensitivity down to single tumor cells without compromising specificity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2010to 26 Aug 2015
- 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
- No healthy volunteers
- Adult, Older adult
Study population: colorectal cancer patients who are treated with cetuximab
Who may be able to join
- Patients with histologically confirmed metastatic colorectal cancer
- Cetuximab-based chemotherapy (monotherapy, combination therapy with cytotoxic chemotherapy such as FOLFOX, XELOX, irinotecan, FOLFIRI, XELIRI, first-line, second-line or third-line are all eligible)
- Age > 18 years.
- ECOG Performance Status of 0-2
- Adequate bone marrow, liver and renal function
- Signed and dated informed consent before the start of specific protocol procedures.
- FNA will be performed in patients with feasible biopsy site; ascites or pleural fluid will be collected in metastatic CRC patients with ascites or pleural effusion
Who cannot join
- Active clinically serious infections (> grade 2 CTCAE version 3.0)
- Patients with evidence or history of bleeding diathesis
- Radiotherapy during study or within 4 weeks of start of study drug.
- Prior exposure to the study drug.
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Trial locations and contacts
1 site in 1 country.
About this study
Prometheus's Onco dX assay platform provides technological breakthrough for immunoassay by obtaining a level of sensitivity down to single tumor cells without compromising specificity. This allows assessment of multiple TKI treatment targets, their activation status, as well as down stream signaling proteins using very tiny amount of tissue that can be obtained by FNA or CTCs.
We planned this study to explore biomarkers predictive of clinical response to cetuximab-based treatment in metastatic colorectal cancer using the Prometheus Platform. We will also elucidate signal transduction pathway attributable to cetuximab resistance, monitor changes in the RTK activation status during cetuximab treatment using circulating tumor cells and analyze correlation between the quantity of circulating tumor cells and treatment response to cetuximab.
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, cetuximab, biomarker, prometheus
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore biomarkers predictive of clinical response to cetuximab-based treatment in metastatic colorectal cancer using the Prometheus Platform
- To analyze expression and activation status of receptor tyrosine kinases in signal transduction pathways in FNA samples and circulating tumor cells B. To identify negative predictive markers to cetuximab
Measured: at Screening (Day - 21 ~ 0 ), at 4 weeks and average 6months(end of treatment)
Secondary outcomes (3)
1. RTK activation status during cetuximab treatment using circulating tumor cells
Measured: at Screening (Day - 21 ~ 0 ), at 4 weeks and average 6months(end of treatment)
2. signal transduction pathway attributable to cetuximab resistance
Measured: at Screening (Day - 21 ~ 0 ), at 4 weeks and EOT (end of treatment)
3. To analyze correlation between the quantity of circulating tumor cells and treatment response to cetuximab
Measured: at Screening (Day - 21 ~ 0 ), at 4 weeks and average 6months (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study start1 Feb 2010
- Primary completionJan 2015
- Study completion26 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Oh Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029326
- Sponsor's protocol ID
- 2009-09-074
- Status last verified
- Feb 2017
- First submitted
- 5 Sep 2013
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Analysis in Metastatic Colorectal Cancer Treated With Cetuximab
- ClinicalTrials.gov ID
- NCT02029326
- Acronym / sponsor ID
- 2009-09-074
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, cetuximab, biomarker, prometheus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- 26 Aug 2015 (actual)
- First posted
- 7 Jan 2014 (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.
Prometheus's Onco dX assay platform provides technological breakthrough for immunoassay by obtaining a level of sensitivity down to single tumor cells without compromising specificity. This allows assessment of multiple TKI treatment targets, their activation status, as well as down stream signaling proteins using very tiny amount of tissue that can be obtained by FNA or CTCs.
We planned this study to explore biomarkers predictive of clinical response to cetuximab-based treatment in metastatic colorectal cancer using the Prometheus Platform. We will also elucidate signal transduction pathway attributable to cetuximab resistance, monitor changes in the RTK activation status during cetuximab treatment using circulating tumor cells and analyze correlation between the quantity of circulating tumor cells and treatment response to cetuximab.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- colorectal cancer patients who are treated with cetuximab
Key inclusion criteria (7 listed)
- Patients with histologically confirmed metastatic colorectal cancer
- Cetuximab-based chemotherapy (monotherapy, combination therapy with cytotoxic chemotherapy such as FOLFOX, XELOX, irinotecan, FOLFIRI, XELIRI, first-line, second-line or third-line are all eligible)
- Age > 18 years.
- ECOG Performance Status of 0-2
- Adequate bone marrow, liver and renal function
Key exclusion criteria (5 listed)
- Active clinically serious infections (> grade 2 CTCAE version 3.0)
- Patients with evidence or history of bleeding diathesis
- Radiotherapy during study or within 4 weeks of start of study drug.
- Prior exposure to the study drug.
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
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
To explore biomarkers predictive of clinical response to cetuximab-based treatment in metastatic colorectal cancer using the Prometheus Platform
Time frame: at Screening (Day - 21 ~ 0 ), at 4 weeks and average 6months(end of treatment)
A. To analyze expression and activation status of receptor tyrosine kinases in signal transduction pathways in FNA samples and circulating tumor cells B. To identify negative predictive markers to cetuximab
3 secondary outcomes
1. RTK activation status during cetuximab treatment using circulating tumor cells
Time frame: at Screening (Day - 21 ~ 0 ), at 4 weeks and average 6months(end of treatment)
2. signal transduction pathway attributable to cetuximab resistance
Time frame: at Screening (Day - 21 ~ 0 ), at 4 weeks and EOT (end of treatment)
3. To analyze correlation between the quantity of circulating tumor cells and treatment response to cetuximab
Time frame: at Screening (Day - 21 ~ 0 ), at 4 weeks and average 6months (end of treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Colorectal Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 23 Feb 2017. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore biomarkers predictive of clinical response to cetuximab-based treatment in metastatic colorectal cancer using the Prometheus Platform (time frame: at Screening (Day - 21 ~ 0 ), at 4 weeks and average 6months(end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2017.