Cervical CancerNCT01371695
Serum IGF-II and Cancer: Can IGF II Levels be Used to Monitor and Screen Patients Specifically for Cervical Cancer
An observational study of Cervical Cancer and Cervical Intraepithelial Neoplasia II, run by Onconix, Inc at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Insulin-like Growth Factor II is elevated sufficiently to detect Cervical Intraepithelial Neoplasia II (CIN II), Cervical Intraepithelial Neoplasia III (CIN III), and cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Cervical Intraepithelial Neoplasia II, Cervical Intraepithelial Neoplasia III
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Sep 2013
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: university clinic
Who may be able to join
- Age 18 - 75 years
- Female
- Normal medical history
- Medical history of a single type of cancer confirmed by biopsy or equivalent criteria
- Squamous cell carcinoma of organs other than cervix
- Adenocarcinoma
Show all 13Show fewer
- Medical history of inflammatory disease
- May be pregnant
- Pap smear positive for Cervical Intraepithelial Neoplasia II or III
- Squamous cell cervical cancer confirmed by biopsy
- Informed consent
- Willingness to submit a blood sample by venipuncture
- Willingness to submit a second blood sample if necessary
Who cannot join
- Age < 18 or > 75 years
- Medical history of cancer other than cervical cancer, Non-islet-cell tumor hypoglycemia, Growth hormone deficiency, Acromegaly, Hepatoma, inflammatory disease in addition to confirmed CIN and cervical cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 of Serum IGF II and Cancer: Can IGF II Levels be Used to Monitor and Screen Patients Specifically for Cervical Cancer
The purpose of this study is to determine whether Insulin-like Growth Factor II is elevated sufficiently to detect Cervical Intraepithelial Neoplasia II (CIN II), Cervical Intraepithelial Neoplasia III (CIN III), and cervical cancer.
- Conditions
- Cervical Cancer, Cervical Intraepithelial Neoplasia II, Cervical Intraepithelial Neoplasia III
- Keywords
- IGF-II levels
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2011 (estimated)
- Study completionSep 2013 (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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onconix, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371695
- Sponsor's protocol ID
- onc11-03-164
- Status last verified
- Jun 2011
- First submitted
- 9 Jun 2011
- Last updated
- 13 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 of Serum IGF II and Cancer: Can IGF II Levels be Used to Monitor and Screen Patients Specifically for Cervical Cancer
- ClinicalTrials.gov ID
- NCT01371695
- Acronym / sponsor ID
- onc11-03-164
- Conditions
- Cervical Cancer, Cervical Intraepithelial Neoplasia II, Cervical Intraepithelial Neoplasia III
- Keywords
- IGF-II levels
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Onconix, IncIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 13 Jun 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 determine whether Insulin-like Growth Factor II is elevated sufficiently to detect Cervical Intraepithelial Neoplasia II (CIN II), Cervical Intraepithelial Neoplasia III (CIN III), and cervical cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- university clinic
Key inclusion criteria (13 listed)
- Age 18 - 75 years
- Female
- Normal medical history
- Medical history of a single type of cancer confirmed by biopsy or equivalent criteria
- Squamous cell carcinoma of organs other than cervix
Key exclusion criteria (2 listed)
- Age < 18 or > 75 years
- Medical history of cancer other than cervical cancer, Non-islet-cell tumor hypoglycemia, Growth hormone deficiency, Acromegaly, Hepatoma, inflammatory disease in addition to confirmed CIN and cervical cancer
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 13 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cervical Intraepithelial Neoplasia II, run by Onconix, 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 13 inclusion and 2 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 13 Jun 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 13 Jun 2011.