Cervical CancerNCT01416922
oncoFISH Cervical Test for Detection of 3q26 Region Gain
An observational study of Cervical Cancer and LSIL, run by Ikonisys, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of the oncoFISH cervical test system in the management of women who have received an LSIL Pap report to determine whether the test can predict which women will progress to more serious cervical disease and which women do not have to be monitored as closely. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, LSIL
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2011
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients 21 years of age or greater with LSIL cytology diagnosis who are scheduled for a colposcical assessment.
Who may be able to join
- Women 21 years of age or greater with recent LSIL who are scheduled for colposcipal assessment.
- Women with previous or current STD or HIV may be included
- Women with previous LSIL history may be included.
Who cannot join
- pregnant women,
- women with vaginal intraepithelial lesions,
- women on a chemotherapeutic agent,
- women with previous or current cancer except for non-cervical squamous cell carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The oncoFISH Cervical Test for Detection of 3q26 Region Gain
The purpose of this study is to evaluate the use of the oncoFISH cervical test system in the management of women who have received an LSIL Pap report to determine whether the test can predict which women will progress to more serious cervical disease and which women do not have to be monitored as closely.
- Conditions
- Cervical Cancer, LSIL
- 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 |
|---|---|---|
| LSIL | Women 21 years of age or older with an LSIL diagnosis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startJun 2009
- Study completionDec 2011 (estimated)
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.
- 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
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ikonisys, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael W Kilpatrick, Ph.D., Study director, Ikonisys, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416922
- Sponsor's protocol ID
- IKON 0801
- Status last verified
- Aug 2011
- First submitted
- 12 Aug 2011
- Last updated
- 15 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The oncoFISH Cervical Test for Detection of 3q26 Region Gain
- ClinicalTrials.gov ID
- NCT01416922
- Acronym / sponsor ID
- IKON 0801
- Conditions
- Cervical Cancer, LSIL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Ikonisys, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Study completion
- Dec 2011 (estimated)
- First posted
- 15 Aug 2011 (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 use of the oncoFISH cervical test system in the management of women who have received an LSIL Pap report to determine whether the test can predict which women will progress to more serious cervical disease and which women do not have to be monitored as closely.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LSIL | – | –Women 21 years of age or older with an LSIL diagnosis |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 21 years of age or greater with LSIL cytology diagnosis who are scheduled for a colposcical assessment.
Key inclusion criteria (3 listed)
- Women 21 years of age or greater with recent LSIL who are scheduled for colposcipal assessment.
- Women with previous or current STD or HIV may be included
- Women with previous LSIL history may be included.
Key exclusion criteria (4 listed)
- pregnant women,
- women with vaginal intraepithelial lesions,
- women on a chemotherapeutic agent,
- women with previous or current cancer except for non-cervical squamous cell carcinoma
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2011.
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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.
Michael W Kilpatrick, Ph.D. study director
Ikonisys, Inc.
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 and LSIL, run by Ikonisys, Inc. 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 3 inclusion and 4 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 15 Aug 2011. 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?
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.
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 Aug 2011.