Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Adenocarcinoma

Uterine Cervical Neoplasms

Precancerous Conditions

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

Papanicolaou test

laboratory biomarker analysis

Tsunehisa Kaku, MD

Keiichi Fujiwara, MD, PhD

RATIONALE: Studying Pap smears in the laboratory from women with atypical glandular cells of unspecified significance may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at Pap smears from women enrolled on clinical trial GOG-171.

OBJECTIVES:

Primary

* To determine the diagnostic accuracy of using previously reported morphometric criteria for chromatin distribution, shortest distance between nuclei, and/or the ratio of nucleoli area to nucleus area in a conventional Pap smear from patients with a cytologic diagnosis of atypical glandular cells of unspecified significance (AGUS) to predict the presence of significant glandular lesions (i.e., adenocarcinoma in situ \[AIS\] or invasive cancer) and/or squamous lesions (i.e., cervical intraepithelial neoplasia \[CIN2 or CIN3\]) of the cervix.

Secondary

* To optimize the diagnostic accuracy of using chromatin distribution, shortest distance between nuclei, and/or the ratio of nucleoli area to nucleus area in a conventional Pap smear from patients with a cytologic diagnosis of AGUS to predict the presence of significant glandular lesions (i.e., AIS or invasive cancer) and/or squamous lesions (i.e., CIN2 or CIN3) of the cervix.

OUTLINE: Previously collected slides from Pap smears of patients enrolled on clinical trial GOG-171 are assessed for nuclear chromatin distribution, the shortest distances between the central points of neighboring cell nuclei, and nucleoli area/nucleus area (N/N) ratio via morphometric analysis.

Study of Pap Smears From Patients Enrolled on Clinical Trial GOG-171

Morphometric Diagnosis of Atypical Glandular Lesions Using a Conventional Pap Smear From GOG-0171 Patients (Enrolled by GOG-Japan) With a Cytologic Diagnosis of Atypical Glandular Cells of Unspecified Significance (AGUS)

National Cancer Institute (NCI)

Gynecologic Oncology Group

All Drugs and Chemicals

Antibodies

Immunoglobulins

Immunologic Factors

cytology specimen collection procedure

fluorescent antibody technique

colposcopic biopsy

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

Women allocated to this arm will be asked to obtain a specimen of vaginal/cervical by self-collection for Hybrid Capture II (HCII).

Women allocated to this arm will be asked to attend to medical office to have their Pap smear obtained by a gynecologist

Women allocated to this arm will be asked to obtain a specimen of vaginal/cervical by self-collection for HCII.

Self-collection

Gynecologist collection

Fabio B Russomano, MD, PhD

A study to investigate the compliance of unassisted women to self-collection of specimens for Hybrid Capture (HC) for detection of Human Papilloma Virus (HPV) DNA compared to Pap smear collection by medical personnel, as screening method to identify precursor lesions of cervical cancer.

Women living in the community of the Morro dos Macacos, Vila Isabel, Rio de Janeiro, were randomly allocated for self-collection of specimens for HC II for detection of HPV-DNA or to Pap smear collection by medical personnel, as screening method to identify precursor lesions of cervical cancer.

The compliance was measured by the delivery of the specimen obtained by self-collection or to attend to a visit at the community health center to be submitted to Pap smear collection, within a week.

Patient Compliance to Self-collection for Detection of HPV-DNA

Patient Compliance to Self-collection for Detection of HPV-DNA in Cervical Cancer Prevention: A Clinical Trial

Risk of compliance to self-collection for detection of HPV-DNA in relation to collection by medical personnel

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Oswaldo Cruz Foundation

This group served as the treatment group for analysis of the primary outcome.

This group served as a wait-list control group, eventually receiving the intervention after the treatment group completed the intervention and the primary outcomes were assessed for both groups.

The focus of the intervention was on reducing participants' self-identified barriers to obtaining Pap tests.

Lay health advisor visits and newsletter

Nancy Schoenberg, Ph.D.

Mark Dignan, Ph.D.

The purpose of this study is to determine whether a faith-placed lay health advisor intervention is effective in increasing use of Pap smears among middle-aged and older Appalachian women.

Project development relied on principles of community based participatory research. Participants were recruited from faith institutions in four distressed Appalachian Kentucky counties. Investigators at the University of Kentucky worked closely with local staff who implemented study procedures in the field.

Faith Moves Mountains: An Appalachian Cervical Cancer Prevention Project

An Appalachian Cervical Cancer Prevention Project

This measure is obtained at multiple timepoints during the study, but as the primary outcome it will be analyzed at the timepoint one month following the Early Intervention group's completion of the intervention.

Nancy Schoenberg

Sponsor/PI

Infections

Symptoms and General Pathology

Immune System Diseases

Digestive System Diseases

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Virus Diseases

Papillomavirus Infections

Papilloma

Anus Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

Dorothy Wiley, Ph.D. RN

RATIONALE: Doctors use a swab to collect cell samples when testing for anal cancer and human papillomavirus. It is not yet known which type of swab is more effective in collecting cell samples for anal Pap tests and human papillomavirus tests in men who have sex with men.

PURPOSE: This clinical trial is comparing two types of swabs in collecting cell samples for anal Pap tests and human papillomavirus tests in men who have sex with men.

OBJECTIVES:

* To determine whether the anal cytology screening outcome derived from specimens collected by a flocked nylon swab are equivalent to those derived from Dacron swab specimens in men who have sex with men.
* To determine whether the number and type-specific identification for human papillomavirus derived from specimens collected by a flocked nylon swab are equivalent to those derived from Dacron swab specimens.

OUTLINE: Dry sterile Dacron swabs and flocked nylon swabs are used to collect intra-anal cytology specimens for anal Pap testing and human papillomavirus typing. Participants undergo a digital rectal examination and high-resolution anoscopy. If lesions are identified, an anal biopsy is performed for histological examination.

Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men

Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy

Jonsson Comprehensive Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Pap Smears From Patients Enrolled on Clinical Trial GOG-171	NCT00898144	Cervical Cancer Precancerous Co...	Papanicolaou te... laboratory biom...	-	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
Patient Compliance to Self-collection for Detection of HPV-DNA	NCT02431520	Compliance Cervical Cancer	Self-collection Gynecologist co...	25 Years - 59 Years	Oswaldo Cruz Foundation
Study of Pap Smears From Patients Enrolled on Clinical Trial GOG-171	NCT00898144	Cervical Cancer Precancerous Co...	Papanicolaou te... laboratory biom...	-	National Cancer Institute (NCI)
Faith Moves Mountains: An Appalachian Cervical Cancer Prevention Project	NCT01372241	Cervical Cancer	Lay health advi...	40 Years - 64 Years	University of Kentucky
Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men	NCT00955591	Anal Cancer Nonneoplastic C... Precancerous Co...	Papanicolaou te...	18 Years -	Jonsson Comprehensive Cancer Center
Study of Pap Smears From Patients Enrolled on Clinical Trial GOG-171	NCT00898144	Cervical Cancer Precancerous Co...	Papanicolaou te... laboratory biom...	-	National Cancer Institute (NCI)

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