Cervical CancerIBCCSPNCT00658190
Internet-Based Cervical Cytology Screening Program
An observational study of Cervical Cancer, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to assess whether a system that couples automated screening of Pap Tests with transmission of machine selected digital images, and review by cytologists at a remote location, performs to a clinically effective standard of accuracy. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- How many people
- 175 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2003to Jan 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 64 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Females presenting to clinics at MGH or WRAMC for a Pap test
Who may be able to join
- Female presenting to clinic for a Pap test for any reason
Who cannot join
- Pregnant
- Prisoners
- Mentally unable to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20001
About this study
The purpose of this study is to assess whether a system that couples automated screening of Pap Tests with transmission of machine selected digital images, and review by cytologists at a remote location, performs to a clinically effective standard of accuracy.
Read the detailed description
This clinical study uses the automated screening capabilities of the FocalPoint Primary Screening System (BD) for gynecologic cytology specimens (Pap tests) to allow for automated field of view (FOV) selection, digital image capture, and subsequent Internet-based transmission to a custom designed computer-based image reading station. The system utilizes liquid-based cytology preparations (ThinPrep, SurePath). In such a system, no skilled cytology human resources are necessary at the scanning site, and all expertise can be centralized. Pilot studies showed that the task was feasible to a clinically relevant standard of care. Phase 1 trials on preselected and seeded specimens confirmed this clinical standard. The phase 2 trials extend the concept to a prospectively enrolled population of patients from 2 sites (Walter Reed, Mass General) thereby testing the concept in a population of normal disease prevalence. The final phase 3 will be a larger study with intended use design, siting a screening device at the 121st Army Hospital in Korea and interpreting the specimen images in the US. In addition to the reading of the specimens, the system is designed to give immediate "loop closing" results back to each specimen's originating point immediate upon completion of the test.
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer, automation, Internet, telecytology
- 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 |
|---|---|---|
| 1 | Women obtaining routine Pap tests for cervical cancer screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical cytology abnormal cases
Identification of abnormalities compared to the initial interpretation
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startOct 2003
- Primary completionDec 2012
- Study completionJan 2013
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.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed Army Medical Center, U.S. Army Medical Research and Development Command
- Responsible party
- Principal investigator, David C. Wilbur, MD, Massachusetts General Hospital
- Investigators
- David C. Wilbur, MD, Principal investigator, MGHBarabara A Crothers, D.O, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658190
- Sponsor's protocol ID
- 2003P-001658
- Other IDs
- PRO33199 W81XWH-04-C-0083
- Acronym
- IBCCSP
- Status last verified
- Apr 2012
- First submitted
- 9 Apr 2008
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Eichhorn JH, Brauns TA, Gelfand JA, Crothers BA, Wilbur DC. A novel automated screening and interpretation process for cervical cytology using the internet transmission of low-resolution images: a feasibility study. Cancer. 2005 Aug 25;105(4):199-206. doi: 10.1002/cncr.21098.
PubMed 15937917
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Cervical Cytology Screening Program
- ClinicalTrials.gov ID
- NCT00658190
- Acronym / sponsor ID
- IBCCSP / 2003P-001658
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer, automation, Internet, telecytology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Walter Reed Army Medical Center, U.S. Army Medical Research and Development Command
- Study start
- Oct 2003
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 14 Apr 2008 (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 assess whether a system that couples automated screening of Pap Tests with transmission of machine selected digital images, and review by cytologists at a remote location, performs to a clinically effective standard of accuracy.
Detailed description
This clinical study uses the automated screening capabilities of the FocalPoint Primary Screening System (BD) for gynecologic cytology specimens (Pap tests) to allow for automated field of view (FOV) selection, digital image capture, and subsequent Internet-based transmission to a custom designed computer-based image reading station. The system utilizes liquid-based cytology preparations (ThinPrep, SurePath). In such a system, no skilled cytology human resources are necessary at the scanning site, and all expertise can be centralized. Pilot studies showed that the task was feasible to a clinically relevant standard of care. Phase 1 trials on preselected and seeded specimens confirmed this clinical standard. The phase 2 trials extend the concept to a prospectively enrolled population of patients from 2 sites (Walter Reed, Mass General) thereby testing the concept in a population of normal disease prevalence. The final phase 3 will be a larger study with intended use design, siting a screening device at the 121st Army Hospital in Korea and interpreting the specimen images in the US. In addition to the reading of the specimens, the system is designed to give immediate "loop closing" results back to each specimen's originating point immediate upon completion of the test.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Women obtaining routine Pap tests for cervical cancer screening |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Females presenting to clinics at MGH or WRAMC for a Pap test
Key inclusion criteria (1 listed)
- Female presenting to clinic for a Pap test for any reason
Key exclusion criteria (3 listed)
- Pregnant
- Prisoners
- Mentally unable to provide informed consent
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
Cervical cytology abnormal cases
Time frame: At enrollment
Identification of abnormalities compared to the initial interpretation
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 7 Apr 2015.
- Background: PubMed 15937917Eichhorn JH, Brauns TA, Gelfand JA, Crothers BA, Wilbur DC. A novel automated screening and interpretation process for cervical cytology using the internet transmission of low-resolution images: a feasibility study. Cancer. 2005 Aug 25;105(4):199-206. doi: 10.1002/cncr.21098.
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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 C. Wilbur, MD principal investigator
MGH
Barabara A Crothers, D.O principal investigator
Walter Reed Army Medical Center
2 sites 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 Massachusetts General Hospital at 2 sites 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 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does the primary outcome measure?
Cervical cytology abnormal cases (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00658190, 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 7 Apr 2015.