CervixNCT00250055
Non-Invasive, Real-Time Technology for Diagnosis of Cervical Tissue
A study testing Colposcopy, Spectroscopy, and Biopsy in people with Cervix and Cancer, run by University of New Mexico at 1 site in United States.
Trial summary
In general, to determine the sensitivity of light transport to tissue from morphological features of clinical significance. Determine how specific structural features contribute to light scattering. Investigate light scattering differences in tumorigenic and nontumorigenic cells. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Colposcopy, Spectroscopy, and Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Jan 2010
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with abnormal Pap smears who are referred for colposcopy.
Who cannot join
- Anyone of the male sex since this study focuses on cervical cell abnormalities
- Any woman who has had a hysterectomy, LEEP, or chemotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: Non-Invasive, Real-time Technology for Diagnosis of Cervical Tissue
In general, to determine the sensitivity of light transport to tissue from morphological features of clinical significance.
Determine how specific structural features contribute to light scattering. Investigate light scattering differences in tumorigenic and nontumorigenic cells.
Develop and implement quantitative and sensitive methods for measuring morphological properties.
Clinical measurements.
Read the detailed description
Patients undergoing a colposcopy will also have spectroscopy measurements taken and an extra biopsy of suspicious tissue.
- Being tested
- Colposcopy, Spectroscopy, and Biopsy
- Keywords
- NIH, Non-Invasive diagnosis of cervical tissue, Los Alamos/NIH
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colposcopy, Spectroscopy, and BiopsyProcedure or surgery
During the colposcopy or LEEP (Loop Electrical Excision Procedure) procedure, or during pelvic exams before surgery after the doctor applies 3% acetic acid to the cervix, the doctor then positions the colposcope to take pictures of the patient's cervix. Digital pictures are taken of the patient's cervix under white light using a colposcopy imaging system. These pictures are annotated by the doctor during the appointment to mark the spectroscopy sites.
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective of this study is to determine whether non-invasive measurements of light transport through tissue can identify pre-cancerous and cancerous conditions.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startApr 2004
- Primary completionDec 2007
- Study completionJan 2010
Why it stopped: This is not Clinical Trial and was inadvertently entered in this system.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CervixStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harriet Smith, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250055
- Sponsor's protocol ID
- 1104C
- Status last verified
- Mar 2024
- First submitted
- 3 Nov 2005
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive, Real-time Technology for Diagnosis of Cervical Tissue
- ClinicalTrials.gov ID
- NCT00250055
- Acronym / sponsor ID
- 1104C
- Keywords
- NIH, Non-Invasive diagnosis of cervical tissue, Los Alamos/NIH
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This is not Clinical Trial and was inadvertently entered in this system.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Apr 2004 (actual)
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 7 Nov 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.
In general, to determine the sensitivity of light transport to tissue from morphological features of clinical significance.
Determine how specific structural features contribute to light scattering. Investigate light scattering differences in tumorigenic and nontumorigenic cells.
Develop and implement quantitative and sensitive methods for measuring morphological properties.
Clinical measurements.
Detailed description
Patients undergoing a colposcopy will also have spectroscopy measurements taken and an extra biopsy of suspicious tissue.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with abnormal Pap smears who are referred for colposcopy.
Key exclusion criteria (2 listed)
- Anyone of the male sex since this study focuses on cervical cell abnormalities
- Any woman who has had a hysterectomy, LEEP, or chemotherapy.
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 |
|---|---|---|
| Colposcopy, Spectroscopy, and BiopsyDuring the colposcopy or LEEP (Loop Electrical Excision Procedure) procedure, or during pelvic exams before surgery after the doctor applies 3% acetic acid to the cervix, the doctor then positions the colposcope to take pictures of the patient's cervix. Digital pictures are taken of the patient's cervix under white light using a colposcopy imaging system. These pictures are annotated by the doctor during the appointment to mark the spectroscopy sites. | Procedure or surgery | – |
Primary outcome
The objective of this study is to determine whether non-invasive measurements of light transport through tissue can identify pre-cancerous and cancerous conditions.
Time frame: 6 years
Results and safety
The study was stopped early (reason given: This is not Clinical Trial and was inadvertently entered in this system.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
Harriet Smith, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colposcopy, Spectroscopy, and Biopsy in people with Cervix and Cancer, run by University of New Mexico 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 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: stopped early, as of the sponsor's last update on 12 Mar 2024. 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: This is not Clinical Trial and was inadvertently entered in this system.). 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?
The objective of this study is to determine whether non-invasive measurements of light transport through tissue can identify pre-cancerous and cancerous conditions. (time frame: 6 years). 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 12 Mar 2024.