Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Neoplasms

Precancerous Conditions

Uterine Cervical Dysplasia

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

fluorophotometry

colposcopic biopsy

colposcopy

light-scattering spectroscopy

Sylvia Lam

RATIONALE: New diagnostic procedures, such as spectroscopy, may be a less invasive way to check for dysplasia and neoplasia in the cervix. Spectroscopy may also used as a screening test to help doctors find cervical cancer sooner, when it may be easier to treat.

PURPOSE: This clinical trial is studying how well spectroscopy works in diagnosing dysplasia and neoplasia in the cervix in women undergoing colposcopy or Pap testing.

OBJECTIVES:

* To identify potential improvements for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using fluorescence and reflectance spectroscopy.
* To measure the reflection and fluorescence spectra in vivo of sites in the human cervix.
* To further refine fluorescence spectroscopy for detection of cervical lesions via better classification of normal columnar tissue and non-neoplastic tissue with inflammation, and low- and high-grade squamous intraepithelial lesions.
* Evaluate and validate the wavelength selections for the spectroscopy device derived from in vitro measurements.
* Determine the sensitivity and specificity of this device for the diagnosis of cervical intraepithelial neoplasia.

OUTLINE: This is a multicenter study. Patients are stratified according to menopausal status and current treatment (premenopausal not on oral contraceptive pills \[OCP\] vs premenopausal on OCP vs postmenopausal not on hormone replacement therapy \[HRT\] vs postmenopausal on HRT).

* Diagnostic study: As part of routine colposcopic evaluation, patients undergo placement of the probe on 1 to 4 sites in the cervix for 2-5 minutes. Up to two colposcopically abnormal sites and two normal sites are biopsied. Blood is drawn for hormone levels. Fluorescence excitation and emission matrix (EEM) data and reflectance spectroscopic information is acquired from patients with an abnormal Papanicolaou smear.
* Screening study: Fluorescence EEM and reflectance spectroscopic information is acquired from patients with a history of normal Papanicolaou smears.

PROJECTED ACCRUAL: A total of 800 patients with abnormal Papanicolaou smears and 1000 subjects with normal Papanicolaou smears are accrued for this study.

Spectroscopy in Diagnosing Dysplasia and Neoplasia in the Cervix in Women Undergoing Colposcopy

Measurement of Fluorescence EEM of Cervical Intraepithelial Neoplasia

National Cancer Institute (NCI)

British Columbia Cancer Agency

Diseases and Abnormalities at or Before Birth

Congenital Abnormalities

Antineoplastic Agents

All Drugs and Chemicals

3,3'-diindolylmethane

Protective Agents

oral microencapsulated diindolylmethane

polymerase chain reaction

cervical Papanicolaou test

cytology specimen collection procedure

Peter Sasieni, MD

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of diindolylmethane, a substance found in cruciferous vegetables, may keep cervical intraepithelial neoplasia or cervical cancer from forming.

PURPOSE: This randomized phase III trial is studying diindolylmethane to see how well it works compared to a placebo in treating patients with abnormal cervical cells.

OBJECTIVES:

* Compare the effect of diindolylmethane vs placebo in reducing the prevalence of histologically proven high-grade cervical intraepithelial neoplasia in patients with low-grade cervical cytological abnormalities.
* Compare the effect of these regimens in reducing the prevalence of cytological abnormalities in these patients.
* Compare the effect of these regimens in changing the clinical appearance of the cervix in these patients.
* Determine if diindolylmethane offers benefits in relation to human papillomavirus (HPV) status, including HPV type, viral load, and integration.
* Determine the side effects of supplementation with diindolylmethane.
* Determine the effects of this drug on migraine, mastalgia, weight, and premenstrual syndrome (PMS).

OUTLINE: This is a double-blind, randomized, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral diindolylmethane once daily for 6 months.
* Arm II: Patients receive oral placebo once daily for 6 months. Patients undergo cervical sampling at baseline and at 6 months for Pap testing by liquid based cytology and human papillomavirus (HPV) testing by polymerase chain reaction. Some patients also undergo urine and hair sample collection at baseline and at 3 and 6 months. Samples are analyzed for estrogen and diindolylmethane metabolites, to monitor patient compliance and response to treatment. Some patients have a cervical photograph taken using a colposcope at baseline and at 6 months. All patients undergo colposcopy at 6 months.

Patients complete a questionnaire at baseline (i.e., for reproductive history, diet, smoking, and premenstrual symptoms) and at 6 months (i.e., for side effects, compliance, changes in smoking, and contraception use). Patients with moderate to severe premenstrual syndrome (PMS) also complete PMS questionnaires once monthly during months 1-6 and 4 months following completion of study therapy. All patients are instructed to maintain current diet and to keep cruciferous vegetables and soy products constant during study course.

After completion of study treatment, patients are followed periodically for up to 7 years.

PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study.

Diindolylmethane in Treating Patients With Abnormal Cervical Cells

An Investigation Into the Effects of Diidolylmethane (BioResponse DIM®) Supplementation in Women With Low-Grade Cervical Cytological Abnormalities [CRISP-1]

Barts and the London School of Medicine and Dentistry

Antibodies

Immunoglobulins

Immunologic Factors

Papanicolaou test

fluorescent antibody technique

study of high risk factors

Phillip Y. Roland, MD

RATIONALE: Examining biomarkers in abnormal cervical cells may improve the ability to detect these cells and plan effective treatment.

PURPOSE: Diagnostic trial to detect specific biomarkers in abnormal cervical cells in women who have abnormal Pap test results.

OBJECTIVES: I. Compare the detection of transferrin receptor, epidermal growth factor receptor, and the MaTu-MN protein in exfoliated cervical epithelial cells from women with abnormal Pap test using fluorescent labeled antibody probe vs histology.

OUTLINE: Patients undergo a Pap test and a colposcopy. Cervical epithelial cells are collected from the most abnormal appearing lesion. Cells are examined for molecular markers using a fluorescent antibody test. The presence or absence of these markers is compared to results of the Pap test and the histology of the cells.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 6 months.

Detection of Biomarkers in Abnormal Cervical Cells in Women With Abnormal Pap Test Results

Development of Antibody-Based Diagnostic Markers for Abnormal Cervical Cells

Northwestern University

John Lurain, MD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Spectroscopy in Diagnosing Dysplasia and Neoplasia in the Cervix in Women Undergoing Colposcopy	NCT00632190	Cervical Cancer Precancerous Co...	fluorophotometr... colposcopic bio... colposcopy light-scatterin...	18 Years -	National Cancer Institute (NCI)
Spectroscopy in Diagnosing Dysplasia and Neoplasia in the Cervix in Women Undergoing Colposcopy	NCT00632190	Cervical Cancer Precancerous Co...	fluorophotometr... colposcopic bio... colposcopy light-scatterin...	18 Years -	National Cancer Institute (NCI)
Diindolylmethane in Treating Patients With Abnormal Cervical Cells	NCT00462813	Cervical Cancer Precancerous Co...	oral microencap... polymerase chai... cervical Papani... cytology specim... colposcopic bio...	-	National Cancer Institute (NCI)
Diindolylmethane in Treating Patients With Abnormal Cervical Cells	NCT00462813	Cervical Cancer Precancerous Co...	oral microencap... polymerase chai... cervical Papani... cytology specim... colposcopic bio...	-	National Cancer Institute (NCI)
Detection of Biomarkers in Abnormal Cervical Cells in Women With Abnormal Pap Test Results	NCT00004091	Cervical Cancer	Papanicolaou te... cytology specim... fluorescent ant... colposcopic bio... study of high r...	-	Northwestern University

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