Liver CancerNCT00994370
Measurement of Pro-angiogenic Markers in Patients With Hepatic Metastases Undergoing SIRT
An observational study of Liver Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This study is being done to investigate the influence of giving radiation to the liver on tumors involving the liver. Investigator is specifically looking at this effect on the blood vessels within the tumor. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Liver Cancer
- Type of treatment
- Injection or infusion
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jan 2013
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects that have undergone Selective Internal Radiation Therapy for the treatment of liver cancer
Who may be able to join
- Patients between the ages of 18-85 who have been referred for SIRT as standard of care treatment for hepatocellular carcinoma or colorectal metastases to the liver and qualify for treatment with SIRT
- Life expectancy of at least 3 months
Who cannot join
- Patients are excluded from participation in this study if they are not undergoing the SIRT procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
About this study
Official title: Measurement of Pro-angiogenic Markers in Patients With Hepatic Metastases Undergoing Selective Internal Radiation Therapy (SIRT)
This study is being done to investigate the influence of giving radiation to the liver on tumors involving the liver. Investigator is specifically looking at this effect on the blood vessels within the tumor. This effect will be measured by studying substances in the blood that the tumors produce and that cause blood vessels to grow. The effects seen on these substances may help design other treatments to improve the results of the radiation used to treat these tumors.
Read the detailed description
Subjects are invited to participate in this study that have undergone a procedure as their standard of care. This procedure is known as Selective Internal Radiation Therapy (SIRT), a procedure designed for the treatment of cancer in the liver. This includes cancer that has started in the liver as well as cancer that has spread to the liver. The purpose of the study is to collect blood samples to assess for "biological markers," or substances within the blood that may promote cancer growth by causing new blood vessels to form. This study will also use a new method of analyzing medical imaging (CT scan, PET scan) to try and better understand how cancer in the liver forms new blood vessels. SIRT is standard therapy and not part of this study. This study involves blood draws only.
- Conditions
- Liver Cancer
- Keywords
- Pro-angiogenic markers, SIRT, hepatic metastases
- Medical subject headings
- Liver 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 |
|---|---|---|
| liver cancer | Patients referred for SIRT will be considered for this investigation. These patients will predominantly have stage IV colorectal metastases with liver dominant metastases or hepatocellular carcinoma. A team of oncologists, interventional radiologists, radiation oncologists and oncologic surgeons will determine that the patients are not candidates for surgical resection or ablative therapy. The patients will then be screened to confirm the patient's eligibility to receive standard of care SIRT treatment. SIRT treatment and imaging studies included in this investigation are standard of care for the patients' liver dominant disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular and peptide pro-angiogenic markers in patients with hepatic malignancy before and after SIRT
Primary objective is to develop assays for both cellular and peptide pro-angiogenic markers and determine variability of these makers in patients with hepatic malignancy before and after Selective Internal Radiation Therapy (SIRT).
Measured: Depending on subject's treatment schedule blood samples are drawn from Day 0 through Day 120 (120 days for whole liver treatment).
Secondary outcomes (1)
Imaging based predictors
To begin to develop imaging based predictors of response to SIRT.
Measured: Depending on subject's treatment schedule blood samples are drawn from Day 0 through Day 120 (120 days for whole liver treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2013
- Study completionJan 2013
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 Liver CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Sirtex Medical
- Responsible party
- Sponsor
- Investigators
- John L Nosher, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994370
- Sponsor's protocol ID
- 0220080303
- Status last verified
- Mar 2014
- First submitted
- 13 Oct 2009
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Carpizo DR, Gensure RH, Yu X, Gendel VM, Greene SJ, Moore DF, Jabbour SK, Nosher JL. Pilot study of angiogenic response to yttrium-90 radioembolization with resin microspheres. J Vasc Interv Radiol. 2014 Feb;25(2):297-306.e1. doi: 10.1016/j.jvir.2013.10.030. Epub 2013 Dec 20.
PubMed 24360887
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Pro-angiogenic Markers in Patients With Hepatic Metastases Undergoing Selective Internal Radiation Therapy (SIRT)
- ClinicalTrials.gov ID
- NCT00994370
- Acronym / sponsor ID
- 0220080303
- Conditions
- Liver Cancer
- Keywords
- Pro-angiogenic markers, SIRT, hepatic metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Sirtex Medical
- Study start
- Apr 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 14 Oct 2009 (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.
This study is being done to investigate the influence of giving radiation to the liver on tumors involving the liver. Investigator is specifically looking at this effect on the blood vessels within the tumor. This effect will be measured by studying substances in the blood that the tumors produce and that cause blood vessels to grow. The effects seen on these substances may help design other treatments to improve the results of the radiation used to treat these tumors.
Detailed description
Subjects are invited to participate in this study that have undergone a procedure as their standard of care. This procedure is known as Selective Internal Radiation Therapy (SIRT), a procedure designed for the treatment of cancer in the liver. This includes cancer that has started in the liver as well as cancer that has spread to the liver. The purpose of the study is to collect blood samples to assess for "biological markers," or substances within the blood that may promote cancer growth by causing new blood vessels to form. This study will also use a new method of analyzing medical imaging (CT scan, PET scan) to try and better understand how cancer in the liver forms new blood vessels. SIRT is standard therapy and not part of this study. This study involves blood draws only.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver cancer | – | –Patients referred for SIRT will be considered for this investigation. These patients will predominantly have stage IV colorectal metastases with liver dominant metastases or hepatocellular carcinoma. A team of oncologists, interventional radiologists, radiation oncologists and oncologic surgeons will determine that the patients are not candidates for surgical resection or ablative therapy. The patients will then be screened to confirm the patient's eligibility to receive standard of care SIRT treatment. SIRT treatment and imaging studies included in this investigation are standard of care for the patients' liver dominant disease. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects that have undergone Selective Internal Radiation Therapy for the treatment of liver cancer
Key inclusion criteria (2 listed)
- Patients between the ages of 18-85 who have been referred for SIRT as standard of care treatment for hepatocellular carcinoma or colorectal metastases to the liver and qualify for treatment with SIRT
- Life expectancy of at least 3 months
Key exclusion criteria (1 listed)
- Patients are excluded from participation in this study if they are not undergoing the SIRT procedure
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
Cellular and peptide pro-angiogenic markers in patients with hepatic malignancy before and after SIRT
Time frame: Depending on subject's treatment schedule blood samples are drawn from Day 0 through Day 120 (120 days for whole liver treatment).
Primary objective is to develop assays for both cellular and peptide pro-angiogenic markers and determine variability of these makers in patients with hepatic malignancy before and after Selective Internal Radiation Therapy (SIRT).
1 secondary outcome
Imaging based predictors
Time frame: Depending on subject's treatment schedule blood samples are drawn from Day 0 through Day 120 (120 days for whole liver 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 20 Mar 2014.
- Results publication: PubMed 24360887Carpizo DR, Gensure RH, Yu X, Gendel VM, Greene SJ, Moore DF, Jabbour SK, Nosher JL. Pilot study of angiogenic response to yttrium-90 radioembolization with resin microspheres. J Vasc Interv Radiol. 2014 Feb;25(2):297-306.e1. doi: 10.1016/j.jvir.2013.10.030. Epub 2013 Dec 20.
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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.
John L Nosher, MD principal investigator
Rutgers, The State University of New Jersey
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 Liver Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 2 inclusion and 1 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 20 Mar 2014. 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 United States. 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?
Cellular and peptide pro-angiogenic markers in patients with hepatic malignancy before and after SIRT (time frame: Depending on subject's treatment schedule blood samples are drawn from Day 0 through Day 120 (120 days for whole liver treatment).). 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 NCT00994370, 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 20 Mar 2014.