Cervical CancerNCT00205010
Laparoscopic Sentinel Lymph Node Localization in Operable Cervix Cancer
An observational study of Cervical Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the feasibility, safety and efficacy of laparoscopic ovarian transposition in women less than 40 years of age with locally advanced cervical squamous cell carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Lymphoscintigraphy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Jun 2006
- 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
Who may be able to join
- Stage IAI to IIA cervix cancer undergoing primary surgical management
Who cannot join
- Previous pelvic dissection
- Previous para-aortic lymph node dissection
- Evidence of distant mets
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Sentinel Lymph Node Localization in Patients With Operable Cervical Cancer - A Pilot Study
The purpose of this study is to evaluate the feasibility, safety and efficacy of laparoscopic ovarian transposition in women less than 40 years of age with locally advanced cervical squamous cell carcinoma
- Conditions
- Cervical Cancer
- Being tested
- Lymphoscintigraphy
- 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.
LymphoscintigraphyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionFeb 2006
- Study completionJun 2006
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 Cervical CancerStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David M Kushner, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205010
- Sponsor's protocol ID
- CO03701
- Other IDs
- H-2003-0442, A532820, SMPH/OBSTET & GYNECOL
- Status last verified
- Jun 2008
- First submitted
- 13 Sep 2005
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kushner DM, Connor JP, Wilson MA, Hafez GR, Chappell RJ, Stewart SL, Hartenbach EM. Laparoscopic sentinel lymph node mapping for cervix cancer--a detailed evaluation and time analysis. Gynecol Oncol. 2007 Sep;106(3):507-12. doi: 10.1016/j.ygyno.2007.04.031. Epub 2007 Jun 8.
PubMed 17560635
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Sentinel Lymph Node Localization in Patients With Operable Cervical Cancer - A Pilot Study
- ClinicalTrials.gov ID
- NCT00205010
- Acronym / sponsor ID
- CO03701
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Feb 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 20 Sep 2005 (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 evaluate the feasibility, safety and efficacy of laparoscopic ovarian transposition in women less than 40 years of age with locally advanced cervical squamous cell carcinoma
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stage IAI to IIA cervix cancer undergoing primary surgical management
Key exclusion criteria (3 listed)
- Previous pelvic dissection
- Previous para-aortic lymph node dissection
- Evidence of distant mets
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 |
|---|---|---|
| Lymphoscintigraphy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 19 Nov 2019.
- Results publication: PubMed 17560635Kushner DM, Connor JP, Wilson MA, Hafez GR, Chappell RJ, Stewart SL, Hartenbach EM. Laparoscopic sentinel lymph node mapping for cervix cancer--a detailed evaluation and time analysis. Gynecol Oncol. 2007 Sep;106(3):507-12. doi: 10.1016/j.ygyno.2007.04.031. Epub 2007 Jun 8.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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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.
David M Kushner, MD principal investigator
University of Wisconsin, Madison
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 Cervical 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 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: finished, as of the sponsor's last update on 19 Nov 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00205010, 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 19 Nov 2019.