Cervical CancerNCT00898144
Study of Pap Smears From Patients Enrolled on Clinical Trial GOG-171
An observational study of Cervical Cancer and Precancerous Condition, run by Gynecologic Oncology Group.
Trial summary
RATIONALE: Studying Pap smears in the laboratory from women with atypical glandular cells of unspecified significance may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancer, Precancerous Condition
- What is being tested?
- Papanicolaou test and laboratory biomarker analysis
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Jun 2009
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Cytologically confirmed atypical glandular cells of unspecified significance
- Original Pap smear used to define the diagnosis must be available for review
- Previously enrolled by GOG-JAPAN onto clinical trialGOG-171
- Must have been eligible and evaluable for the primary objective of GOG-171
- Gave permission to use specimens for future cancer research in GOG-171
- Underwent a loop electrosurgical excision procedure/large loop excision of the transformation zone (LEEP/LLETZ) procedure on clinical trial GOG-171 to determine the presence of cervical intraepithelial neoplasia (CIN-2 or CIN-3), significant glandular lesions (AIS), or invasive cancer
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Morphometric Diagnosis of Atypical Glandular Lesions Using a Conventional Pap Smear From GOG-0171 Patients (Enrolled by GOG-Japan) With a Cytologic Diagnosis of Atypical Glandular Cells of Unspecified Significance (AGUS)
RATIONALE: Studying Pap smears in the laboratory from women with atypical glandular cells of unspecified significance may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at Pap smears from women enrolled on clinical trial GOG-171.
Read the detailed description
OBJECTIVES:
Primary
- To determine the diagnostic accuracy of using previously reported morphometric criteria for chromatin distribution, shortest distance between nuclei, and/or the ratio of nucleoli area to nucleus area in a conventional Pap smear from patients with a cytologic diagnosis of atypical glandular cells of unspecified significance (AGUS) to predict the presence of significant glandular lesions (i.e., adenocarcinoma in situ [AIS] or invasive cancer) and/or squamous lesions (i.e., cervical intraepithelial neoplasia [CIN2 or CIN3]) of the cervix.
Secondary
- To optimize the diagnostic accuracy of using chromatin distribution, shortest distance between nuclei, and/or the ratio of nucleoli area to nucleus area in a conventional Pap smear from patients with a cytologic diagnosis of AGUS to predict the presence of significant glandular lesions (i.e., AIS or invasive cancer) and/or squamous lesions (i.e., CIN2 or CIN3) of the cervix.
OUTLINE: Previously collected slides from Pap smears of patients enrolled on clinical trial GOG-171 are assessed for nuclear chromatin distribution, the shortest distances between the central points of neighboring cell nuclei, and nucleoli area/nucleus area (N/N) ratio via morphometric analysis.
- Conditions
- Cervical Cancer, Precancerous Condition
- Being tested
- Papanicolaou test, laboratory biomarker analysis
- Keywords
- cervical cancer, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, cervical adenocarcinoma, atypical squamous cells of undetermined significance
- Medical subject headings
- Uterine Cervical Neoplasms, Precancerous Conditions, Uterine Cervical Dysplasia, Atypical Squamous Cells of the Cervix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papanicolaou testOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of CIN-2 or CIN-3, significant glandular lesions (AIS), or invasive cancer as determined by the GOG Central Pathology Review of the loop electrosurgical excision procedure/large loop excision of the transformation zone tissue specimen
Secondary outcomes (3)
Intensity of nuclear chromatin staining and chromatin distribution
Distance between neighboring nuclei
Nucleoli area to nucleus area ratio (N/N)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startFeb 2008
- Primary completionJun 2009 (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
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Tsunehisa Kaku, MD, Study chair, Kyushu University HospitalKeiichi Fujiwara, MD, PhD, Saitama Medical University International Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898144
- Sponsor's protocol ID
- CDR0000600575
- Other IDs
- GOG-8007
- Status last verified
- Nov 2010
- First submitted
- 9 May 2009
- Last updated
- 8 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphometric Diagnosis of Atypical Glandular Lesions Using a Conventional Pap Smear From GOG-0171 Patients (Enrolled by GOG-Japan) With a Cytologic Diagnosis of Atypical Glandular Cells of Unspecified Significance (AGUS)
- ClinicalTrials.gov ID
- NCT00898144
- Acronym / sponsor ID
- CDR0000600575
- Conditions
- Cervical Cancer, Precancerous Condition
- Keywords
- cervical cancer, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, cervical adenocarcinoma, atypical squamous cells of undetermined significance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2008
- Primary completion
- Jun 2009 (estimated)
- First posted
- 12 May 2009 (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.
RATIONALE: Studying Pap smears in the laboratory from women with atypical glandular cells of unspecified significance may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at Pap smears from women enrolled on clinical trial GOG-171.
Detailed description
OBJECTIVES:
Primary
- To determine the diagnostic accuracy of using previously reported morphometric criteria for chromatin distribution, shortest distance between nuclei, and/or the ratio of nucleoli area to nucleus area in a conventional Pap smear from patients with a cytologic diagnosis of atypical glandular cells of unspecified significance (AGUS) to predict the presence of significant glandular lesions (i.e., adenocarcinoma in situ [AIS] or invasive cancer) and/or squamous lesions (i.e., cervical intraepithelial neoplasia [CIN2 or CIN3]) of the cervix.
Secondary
- To optimize the diagnostic accuracy of using chromatin distribution, shortest distance between nuclei, and/or the ratio of nucleoli area to nucleus area in a conventional Pap smear from patients with a cytologic diagnosis of AGUS to predict the presence of significant glandular lesions (i.e., AIS or invasive cancer) and/or squamous lesions (i.e., CIN2 or CIN3) of the cervix.
OUTLINE: Previously collected slides from Pap smears of patients enrolled on clinical trial GOG-171 are assessed for nuclear chromatin distribution, the shortest distances between the central points of neighboring cell nuclei, and nucleoli area/nucleus area (N/N) ratio via morphometric analysis.
Study design
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Papanicolaou test | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Presence of CIN-2 or CIN-3, significant glandular lesions (AIS), or invasive cancer as determined by the GOG Central Pathology Review of the loop electrosurgical excision procedure/large loop excision of the transformation zone tissue specimen
3 secondary outcomes
Intensity of nuclear chromatin staining and chromatin distribution
Distance between neighboring nuclei
Nucleoli area to nucleus area ratio (N/N)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2010.
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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.
Tsunehisa Kaku, MD study chair
Kyushu University Hospital
Keiichi Fujiwara, MD, PhD
Saitama Medical University International Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Precancerous Condition, run by Gynecologic Oncology Group.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Presence of CIN-2 or CIN-3, significant glandular lesions (AIS), or invasive cancer as determined by the GOG Central Pathology Review of the loop electrosurgical excision procedure/large loop excision of the transformation zone tissue specimen. 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 8 Nov 2010.