Rectal CancerNCT01706809
Comparing of Different Biomarkers From Vena Rectalis Superior and Vena Cubiti in Patients Undergoing Low Anterior Resection for Rectum Cancer
An observational study of Rectal Cancer, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF and others ability to predict time to recidive and progressions free survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- blood sampels from vena rectalis superior and vena cubiti
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to Dec 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: Patients undergoing open LAR for rectum cancer is subjected.
Who may be able to join
- Histological verified cancer
- The cancer must be located in rectum maximum of 15 cm.
- Age above 18
Who cannot join
- Disseminated cancer
- Perioperative radio-chemotherapy
- Laparoscopy surgery
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Vejle hospital
Vejle, Vejle, 5000
Hans Rahr, MD, 7940 5600 ext. 0045, hans.rahr@slb.regionsyddanmark.dk
About this study
The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF and others ability to predict time to recidive and progressions free survival.
Read the detailed description
Patients undergoing LAR for rectum cancer is subjected. Preoperative blood samples from vena rectalis superior and vena cubiti is collected, as well as biopsies from tumor. Preoperative and after 3 month peripheral blood samples is collected.
A total of 50 patients will be included in this study.
The study is approved by the local scientific ethical committee No. S-20100006
- Conditions
- Rectal Cancer
- Being tested
- blood sampels from vena rectalis superior and vena cubiti
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampels from vena rectalis superior and vena cubitiOther
| Study group | Role | What they receive |
|---|---|---|
| Biomarkeres | Not described Receives: Other: blood sampels from vena rectalis superior and vena cubiti |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF and others ability to predict time to recidive and progressions free survival.
Measured: after the study is complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Ellebaek Pedersen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706809
- Sponsor's protocol ID
- S-20100006
- Other IDs
- S-20100006
- Status last verified
- Feb 2014
- First submitted
- 11 Oct 2012
- Last updated
- 5 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing of Different Biomarkers From Vena Rectalis Superior and Vena Cubiti in Patients Undergoing Low Anterior Resection for Rectum Cancer
- ClinicalTrials.gov ID
- NCT01706809
- Acronym / sponsor ID
- S-20100006
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 15 Oct 2012 (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.
The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF and others ability to predict time to recidive and progressions free survival.
Detailed description
Patients undergoing LAR for rectum cancer is subjected. Preoperative blood samples from vena rectalis superior and vena cubiti is collected, as well as biopsies from tumor. Preoperative and after 3 month peripheral blood samples is collected.
A total of 50 patients will be included in this study.
The study is approved by the local scientific ethical committee No. S-20100006
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarkeres | – | Other: blood sampels from vena rectalis superior and vena cubiti |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing open LAR for rectum cancer is subjected.
Key inclusion criteria (3 listed)
- Histological verified cancer
- The cancer must be located in rectum maximum of 15 cm.
- Age above 18
Key exclusion criteria (3 listed)
- Disseminated cancer
- Perioperative radio-chemotherapy
- Laparoscopy surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampels from vena rectalis superior and vena cubiti | Other | Biomarkeres |
Primary outcome
The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF and others ability to predict time to recidive and progressions free survival.
Time frame: after the study is complete
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2014.
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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.
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 Rectal Cancer, run by Odense University Hospital at 1 site in Denmark.
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 3 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 5 Feb 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 Denmark. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF and others ability to predict time to recidive and progressions free survival. (time frame: after the study is complete). 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 5 Feb 2014.