Cervix CancerNCT00571415
Image-guided Adaptive Radiotherapy for Cervix Cancer: Patient Image Acquisition
An observational study of Cervix Cancer, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Within this study patient data are collected from different imaging and motion monitoring devices that will be used to develop and test strategies for image-guided adaptive radiotherapy in cervix cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervix Cancer
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Oct 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: University hospital clinic
Who may be able to join
- Histological diagnosis of cervix cancer
- Prescription of radiation treatment to the primary cancer
Who cannot join
- Prior radiation treatment to the pelvis
Trial locations and contacts
1 site in 1 country.
United States1 site
Viriginia Commonwealth University, Department of Radiation Oncology
Richmond, Virginia, 23298
About this study
Within this study patient data are collected from different imaging and motion monitoring devices that will be used to develop and test strategies for image-guided adaptive radiotherapy in cervix cancer patients.
- Conditions
- Cervix Cancer
- Keywords
- Image guided adaptive radiotherapy
- Medical subject headings
- Uterine Cervical 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 |
|---|---|---|
| cervix cancer patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in therapeutic ratio
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startMar 2009
- Primary completionMay 2013
- Study completionOct 2015
Why it stopped: Due to competing studies no further subjects could be recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeffrey F Williamson, PhD, Principal investigator, Virginia Commonwealth University, Department of Radiation OncologyJeffrey F Williamson, PhD, Study director, VCU, Richmond, VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571415
- Sponsor's protocol ID
- HM10390
- Other IDs
- P01CA116602
- Status last verified
- May 2016
- First submitted
- 11 Dec 2007
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-guided Adaptive Radiotherapy for Cervix Cancer: Patient Image Acquisition
- ClinicalTrials.gov ID
- NCT00571415
- Acronym / sponsor ID
- HM10390
- Conditions
- Cervix Cancer
- Keywords
- Image guided adaptive radiotherapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to competing studies no further subjects could be recruited.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2009
- Primary completion
- May 2013 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 12 Dec 2007 (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.
Within this study patient data are collected from different imaging and motion monitoring devices that will be used to develop and test strategies for image-guided adaptive radiotherapy in cervix cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cervix cancer patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University hospital clinic
Key inclusion criteria (2 listed)
- Histological diagnosis of cervix cancer
- Prescription of radiation treatment to the primary cancer
Key exclusion criteria (1 listed)
- Prior radiation treatment to the pelvis
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
Increase in therapeutic ratio
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Due to competing studies no further subjects could be recruited.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
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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.
Jeffrey F Williamson, PhD principal investigator
Virginia Commonwealth University, Department of Radiation Oncology
Jeffrey F Williamson, PhD study director
VCU, Richmond, VA
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 Cervix Cancer, run by Virginia Commonwealth University 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: stopped early, as of the sponsor's last update on 1 Jun 2016. 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 was stopped early (reason given: Due to competing studies no further subjects could be recruited.). 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?
Increase in therapeutic ratio (time frame: 5 years). 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 1 Jun 2016.