Rectal CancerNCT00585728
CT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer
A study testing CT Virtual Proctoscopy (CTVP) in people with Rectal Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to see how CT virtual proctoscopy compares to an ultrasound exam of the rectal area in determining the stage of rectal cancer for people recently diagnosed with rectal cancer. 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?
- CT Virtual Proctoscopy (CTVP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Aug 2011
- Phase
- Interventional
- 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
Who may be able to join
- Patients who have been diagnosed with adenocarcinoma of the rectum, who have not started their neoadjuvant treatment yet.
Who cannot join
- Patients who have started their neoadjuvant therapy already
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792
About this study
The purpose of this study is to see how CT virtual proctoscopy compares to an ultrasound exam of the rectal area in determining the stage of rectal cancer for people recently diagnosed with rectal cancer. This study will also compare tumor volume before and after neoadjuvant therapy using CT virtual proctoscopy, with the ultrasound exam as a comparison. Neoadjuvant therapy consists of chemotherapy and radiation therapy. Neoadjuvant chemoradiation therapy is done before surgery to reduce the size of tumors.
- Conditions
- Rectal Cancer
- Being tested
- CT Virtual Proctoscopy (CTVP)
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT Virtual Proctoscopy (CTVP)Procedure or surgery
CTVP done prior to initiation of therapy and a couple of weeks before patient has surgery.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | CT virtual proctoscopy Receives: Procedure: CT Virtual Proctoscopy (CTVP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The utility of CT virtual proctoscopy (CTVP) for evaluation of rectal cancer.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionAug 2011
- Study completionAug 2011
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 University of Wisconsin, MadisonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles P Heise, M.D., Principal investigator, UW Hospital & Clinics, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585728
- Sponsor's protocol ID
- 2007-0134 (CC07206)
- Other IDs
- A534260, SMPH\MEDICINE\HEM-ONC, 2007-0134
- Status last verified
- Aug 2011
- First submitted
- 21 Dec 2007
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer
- ClinicalTrials.gov ID
- NCT00585728
- Acronym / sponsor ID
- 2007-0134 (CC07206)
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 3 Jan 2008 (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 purpose of this study is to see how CT virtual proctoscopy compares to an ultrasound exam of the rectal area in determining the stage of rectal cancer for people recently diagnosed with rectal cancer. This study will also compare tumor volume before and after neoadjuvant therapy using CT virtual proctoscopy, with the ultrasound exam as a comparison. Neoadjuvant therapy consists of chemotherapy and radiation therapy. Neoadjuvant chemoradiation therapy is done before surgery to reduce the size of tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: CT Virtual Proctoscopy (CTVP)CT virtual proctoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have been diagnosed with adenocarcinoma of the rectum, who have not started their neoadjuvant treatment yet.
Key exclusion criteria (1 listed)
- Patients who have started their neoadjuvant therapy already
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 |
|---|---|---|
| CT Virtual Proctoscopy (CTVP)CTVP done prior to initiation of therapy and a couple of weeks before patient has surgery. | Procedure or surgery | 1 |
Primary outcome
The utility of CT virtual proctoscopy (CTVP) for evaluation of rectal cancer.
Time frame: 3 months
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 13 Dec 2019.
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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.
Charles P Heise, M.D. principal investigator
UW Hospital & Clinics, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT Virtual Proctoscopy (CTVP) in people with Rectal Cancer, run by University of Wisconsin, Madison 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 1 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 13 Dec 2019. 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?
The utility of CT virtual proctoscopy (CTVP) for evaluation of rectal cancer. (time frame: 3 months). 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 13 Dec 2019.