Cervical CancerNCT00204997
Preservation of Ovarian Function Via LOT in Squamous Cell Carcinoma of the Cervix
A study testing Laparoscopic ovarian transposition in people with 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 to 40 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Laparoscopic ovarian transposition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Feb 2008
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Newly diagnosed Stages iB-iiiB squamous cell carcinoma of the cervix
Who cannot join
- Evidence of ovarian involvement on MRI
- Evidence of uterine involvement on MRI
- Evidence of distant mets on MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preservation of Ovarian Function Via Laparoscopic Transposition in Patients With Locally Advanced Squamous Cell Carcinoma of the Cervix
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
- Laparoscopic ovarian transposition
- Keywords
- Cervical Cancer, Squamous Cell, Laparoscopy, Ovarian Function
- 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.
Laparoscopic ovarian transpositionProcedure or surgery
Laparoscopic ovarian transposition
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Laparoscopic Ovarian Transposition Receives: Procedure: Laparoscopic ovarian transposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause
Measured: 6 months
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 startSep 2002
- Primary completionSep 2005
- Study completionFeb 2008
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
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
- NCT00204997
- Sponsor's protocol ID
- CO02702
- Other IDs
- 2002-255, A532820, SMPH/OBSTET & GYNECOL/OBSTET
- Status last verified
- Jun 2008
- First submitted
- 13 Sep 2005
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservation of Ovarian Function Via Laparoscopic Transposition in Patients With Locally Advanced Squamous Cell Carcinoma of the Cervix
- ClinicalTrials.gov ID
- NCT00204997
- Acronym / sponsor ID
- CO02702
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, Squamous Cell, Laparoscopy, Ovarian Function
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Sep 2002
- Primary completion
- Sep 2005 (actual)
- Study completion
- Feb 2008 (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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Laparoscopic ovarian transpositionLaparoscopic Ovarian Transposition |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Newly diagnosed Stages iB-iiiB squamous cell carcinoma of the cervix
Key exclusion criteria (3 listed)
- Evidence of ovarian involvement on MRI
- Evidence of uterine involvement on MRI
- Evidence of distant mets on MRI
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 |
|---|---|---|
| Laparoscopic ovarian transpositionLaparoscopic ovarian transposition | Procedure or surgery | 1 |
Primary outcome
Menopause
Time frame: 6 months
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- 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?
A study testing Laparoscopic ovarian transposition in people with 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: stopped early, as of the sponsor's last update on 15 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 was stopped early (reason given: slow accrual). 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?
Menopause (time frame: 6 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 15 Nov 2019.