Metastatic Colorectal CancerNCT02423785
Ocular Blood Flow in Colorectal Cancer Patients
An observational study of Metastatic Colorectal Cancer, run by Medical University of Vienna at 1 site in Austria.
Trial summary
In colorectal cancer therapy anti-angiogenic strategies have become a cornerstone of treatment regimens in the metastatic setting. Addition of bevacizumab to conventional chemotherapeutic combination regimens has improved the median overall survival of advanced colorectal cancer patients by approximately 5 months. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- How many people
- 11 participants
- Where
- 1 siteAustria
- Study dates
- May 2014to Jan 2022
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, who are treated at the Medical University of Vienna
Who may be able to join
- Male or female patients (age 18 and over) suffering from mCRC.
- Normal findings in ophthalmic examination (except the investigator finds an abnormality irrelevant for the purpose of the study.)
- Patients, which are scheduled for standard of care treatment with chemotherapy plus bevacizumab
Who cannot join
- Refusal to give informed consent
- Severe hypertension (RR ≥180/110)
- Epilepsy
- Pregnancy and breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study Investigating Ocular Blood Flow in Colorectal Cancer Patients Before and After Treatment With Anti-angiogenic Therapy
In colorectal cancer therapy anti-angiogenic strategies have become a cornerstone of treatment regimens in the metastatic setting. Addition of bevacizumab to conventional chemotherapeutic combination regimens has improved the median overall survival of advanced colorectal cancer patients by approximately 5 months. Selecting patients, who will benefit from anti-angiogenic approaches, would be highly desirable in order to optimize treatment strategies. Changes in ocular blood flow may be an attractive biomarker for predicting treatment response. In light of the given alternative first line treatment options such a predictive biomarker would be of clinical benefit. In the proposed study the investigators will assess potential changes in the ocular blood flow of mCRC patients after treatment with standard of care anti-angiogenic/cytotoxic therapy as an early predictive marker of treatment response as assessed by standard CT-scan
- Conditions
- Metastatic Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between ocular blood flow (retinal blood flow) and treatment response
mean RBCs velocity in Hz and blood flow in arbitrary units will be reported and correlated with response rates (CR,PR,SD or PD)
Measured: Within 2-3 months at restaging
Correlation between retinal vessel diameter and treatment response
Retinal vessel diameter will be reported and correlated with response rates (CR,PR,SD or PD)
Measured: Within 2-3 months at restaging
Changes in retinal surface before and after therapy as measured by optical coherence tomography
Measured: Within 2-3 months at restaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startMay 2014
- Primary completionJan 2022
- Study completionJan 2022
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thorsten Fuereder, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423785
- Sponsor's protocol ID
- OBF-13
- Status last verified
- Apr 2022
- First submitted
- 31 Jul 2014
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study Investigating Ocular Blood Flow in Colorectal Cancer Patients Before and After Treatment With Anti-angiogenic Therapy
- ClinicalTrials.gov ID
- NCT02423785
- Acronym / sponsor ID
- OBF-13
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2022 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 22 Apr 2015 (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.
In colorectal cancer therapy anti-angiogenic strategies have become a cornerstone of treatment regimens in the metastatic setting. Addition of bevacizumab to conventional chemotherapeutic combination regimens has improved the median overall survival of advanced colorectal cancer patients by approximately 5 months. Selecting patients, who will benefit from anti-angiogenic approaches, would be highly desirable in order to optimize treatment strategies. Changes in ocular blood flow may be an attractive biomarker for predicting treatment response. In light of the given alternative first line treatment options such a predictive biomarker would be of clinical benefit. In the proposed study the investigators will assess potential changes in the ocular blood flow of mCRC patients after treatment with standard of care anti-angiogenic/cytotoxic therapy as an early predictive marker of treatment response as assessed by standard CT-scan
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, who are treated at the Medical University of Vienna
Key inclusion criteria (3 listed)
- Male or female patients (age 18 and over) suffering from mCRC.
- Normal findings in ophthalmic examination (except the investigator finds an abnormality irrelevant for the purpose of the study.)
- Patients, which are scheduled for standard of care treatment with chemotherapy plus bevacizumab
Key exclusion criteria (4 listed)
- Refusal to give informed consent
- Severe hypertension (RR ≥180/110)
- Epilepsy
- Pregnancy and breastfeeding women
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
Correlation between ocular blood flow (retinal blood flow) and treatment response
Time frame: Within 2-3 months at restaging
mean RBCs velocity in Hz and blood flow in arbitrary units will be reported and correlated with response rates (CR,PR,SD or PD)
Correlation between retinal vessel diameter and treatment response
Time frame: Within 2-3 months at restaging
Retinal vessel diameter will be reported and correlated with response rates (CR,PR,SD or PD)
Changes in retinal surface before and after therapy as measured by optical coherence tomography
Time frame: Within 2-3 months at restaging
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
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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 Metastatic Colorectal Cancer, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 29 Apr 2022. 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 Austria. 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 was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
Correlation between ocular blood flow (retinal blood flow) and treatment response (time frame: Within 2-3 months at restaging). The study lists 3 primary outcomes in all. 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 29 Apr 2022.