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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00511615 |
The hypothesis of this research project is that topical application of the anti-EGFR or anti-E6/E7 contrast agents followed by optical imaging will yield images that reflect spatial variations in expression that correlate with the presence of cervical precancer. To gather feasibility data the investigators will:
Condition | Intervention |
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Cervical Cancer |
Procedure: Loop Electrosurgical Excision Procedure |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | A Feasibility Study of Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia |
Tissue sample removal from the cervix using LEEP during the scheduled colposcopy.
Estimated Enrollment: | 80 |
Study Start Date: | March 2005 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Patients with cervical cancer scheduled to be treated with the LEEP procedure.
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Procedure: Loop Electrosurgical Excision Procedure
Tissue sample will be removed from the cervix. The LEEP is the standard of care treatment for the precancerous condition on your cervix.
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During your scheduled colposcopy, a sample of tissue will be removed from your cervix using the loop electrosurgical excision procedure (LEEP). The LEEP is the standard of care treatment for the precancerous condition on your cervix. The details of the procedure will be covered in another consent form. Before the LEEP, a photograph will be taken of the cervix. This photograph will be taken for research purposes, so that researchers will have a photograph to compare to the images taken with the MDC and Confocal.
The tissue that is removed will be taken to a room where the researchers will use a special microscope to look at the tissue before and after the new contrast agent is painted on the surface of the tissue. After the tissue samples are looked at, they will be sent to the lab for routine tests (as part of your standard of care).
You will require a LEEP whether you participate in this study or not. The tissue removal is a standard part of the LEEP. The experimental portion of this study is the use of the contrast agent. Once that portion is complete, the tissue will be tested as per standard of care. The tissue will not be used for any other research testing.
You will not be told of any of the experimental findings with the contrast agent. However, your doctor and/or nurse practitioner will be told the results of the routine tests, and they will give these results to you.
This is an investigational study. The LEEP is considered standard of care and any charges associated with the LEEP will be the responsibility of you and/or your insurance provider. Up to 80 women will take part in this multicenter study. Up to 40 will be enrolled at M.D. Anderson.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with cervical cancer scheduled to be treated with the LEEP procedure.
Inclusion Criteria:
Exclusion Criteria:
Contact: Michele Follen, MD, PhD | 713-745-4780 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Michele Follen, MD, PhD | |
UT Health Science Center-Houston | Recruiting |
Houston, Texas, United States, 77030 | |
Lyndon B. Johnson Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Canada, British Columbia | |
British Columbia Cancer Agency | Recruiting |
Vancouver, British Columbia, Canada |
Principal Investigator: | Michele Follen, MD, PhD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Michele Follen, MD, PhD/Professor ) |
Study ID Numbers: | 2004-0862 |
Study First Received: | August 2, 2007 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00511615 |
Health Authority: | United States: Institutional Review Board |
Cervical Intraepithelial Neoplasia Loop Electrosurgical Excision Procedure Cervical Cancer |
Colposcopy Molecular Imaging LEEP |
Cervical intraepithelial neoplasia Carcinoma in Situ Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |
Neoplasms Neoplasms by Histologic Type |