Cervical Cancer Clinical Trial
Official title:
A Randomized Trial of Spectroscopy Versus Standard Care in Cervical Intraepithelial Neoplasia
Verified date | December 2012 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Primary objectives
1. To conduct a randomized clinical trial of the emerging technology fluorescence and
reflectance spectroscopy, comparing colposcopy to colposcopy + spectroscopy in the
diagnostic setting, stratifying patients by outside Papanicolaou (Pap) smear of low
grade and high grade squamous intraepithelial lesions, and to use multispectral digital
colposcopy retrospectively.
The number of clinically read referral Paps, clinically read UT MD Anderson Cancer
Center (MDACC) Paps, quantitatively read Paps, quantitatively read biopsies, point
probe fluorescence/reflectance spectroscopy, and the multi-spectral digital colposcopy
image, that shows a possible cancer, High-grade Squamous Intraepithelial Lesion
(HGSIL), Low-grade Squamous Intraepithelial Lesion (LGSIL), or changes less than LGSIL
to colposcopically directed biopsies at the first visit, Loop Electrical Excision
Procedure (LEEP) at the second visit if needed, repeat evaluations at 6, 12, and 18
months that have Paps, or Paps + Endocervical Curettage or sample of the cervical canal
+ possible biopsy, and at the 24 month visit when all patients will at minimum have a
Pap and an Endocervical Curettage for certain, and a cervical biopsy if any colposcopic
abnormality is present.
2. To see if optical spectroscopy using both the point probe and the multi-spectral device
improves diagnosis by improving specificity over colposcopy alone.
1. To study the number of colposcopically directed biopsies that show High-grade
Squamous Intraepithelial or cancer.
2. To study the number of LEEP specimens that show HGSIL or cancer.
Status | Terminated |
Enrollment | 2 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients 18 years and older - Non-pregnant - Patients with abnormal smears with cervical intraepithelial neoplasia (both low grade squamous intraepithelial lesions and high grade squamous intraepithelial lesions equal to cervical intraepithelial neoplasia 1-3) Exclusion Criteria: - Patients who have had cytotoxic chemotherapy within 12-months prior to enrolling in this study, since the chemotherapy often induces change in the cervix. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | British Columbia Cancer Research Centre | Vancouver | British Columbia |
United States | Lyndon Baines Johnson General Hospital | Houston | Texas |
United States | UT MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Unnecessary Loop Electrosurgical Excision Procedures (LEEP) | A LEEP is unnecessary if histological examination results in diagnosis of low grade squamous intraepithelial lesion or normal. Comparison of 3 arms (colposcopy to colposcopy + spectroscopy, colposcopy + LEEP Procedure) in the diagnostic setting, stratifying participants by outside Papanicolaou (Pap) smear of low grade and high grade squamous intraepithelial lesions, and to use multispectral digital colposcopy retrospectively, in identifying unnecessary LEEPs performed. | Up to 2 years | No |
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