Cervical Cancer Early Endpoints and Determinants

NCT00339989 | Completed

• 2 other identifiers: 99990330203-C-N302
• Study Type: observational
• Target: 3,013
• Locations: 1 country
• Sites: 1

Brief Summary

This study, conducted by the National Cancer Institute and the University of Oklahoma, will look for changes in cervix cells and other samples that may be signs of cervical disease. Human papilloma virus, or HPV, is a common infection of the genitalia in women that usually goes away by itself. If HPV infection does not go away, it might turn into cancer of the cervix, although this is rare. This study will examine why many HPV infections go away and why a few persist and lead to cervical cancer. Women 18 years of age and older who are referred for colposcopy (examination of the vagina and cervix using an instrument with a magnifying lens) at the University of Oklahoma following Pap smear diagnosis may be eligible for this study. Women will be in one of the following diagnostic categories:

• Cancer: Stage 1-2 only.
• Precancer: Cervical intraepithelial neoplasia (CIN3).
• HPV-infected: Positive for any of the 13 known cancer-causing HPV types, but not diagnosed with cancer or CIN3.
• Normal: Negative for cancer-causing HPV and normal tissue laboratory results. Participants will undergo the following procedures:
• Questionnaire: Covers demographic information (such as age, race, ethnicity, marital status, etc.), pregnancy history, menstrual and sexual history, contraceptive history, hormone medication history, medical history, smoking history, physical development, family history, and health care access.
• Blood test: 2 tablespoons of blood drawn.
• Colposcopy.
• Procedure to collect a sample of cervical cells and fluids for HPV testing and research.

Conditions

Cervical Cancer; Cervical Intraepithelial; Neoplasia; CIN

Keywords

Molecular Markers; Human Papillomavirus; Cervix; Cancer; Microarray

Outcome Measures

Primary Outcomes (1)

• Histology from biopsy or surgery

  Cervical precancer and cancer

  Cross-sectional

Study Arms (1)

Women undergoing colposcopy

women attending the University of Oklahoma Colposcopy Clinic

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study enrolled women attending the University of Oklahoma Colposcopy Clinic.

You may qualify if:

• All women who are referred for cervical colposcopy to the University of Oklahoma will be considered eligible for the study. These women will be categorized into four groups: (i) cancer, (ii) precancer, (iii) HPV-infected, and (iv) normal. Cancers will be limited to women diagnosed with early cancer (Stage 1-2) to minimize potential disease effects. Precancers will be defined as women diagnosed histologically with cervical intraepithelial neoplasia 3 (CIN3). This is a highly specific and well-reproduced diagnosis which effectively represents carcinoma in situ. All women testing DNA positive for any of the 13 known oncogenic HPV types (HPV-infected), but not diagnosed with CIN3 or cancer (all stages) will be placed in the HPV-positive group. This group will therefore encompass all HPV-infected women diagnosed with either cervical intraepithelial neoplasia 1 (CIN1), CIN2, low grade squamous intraepithelial lesion (LSIL), atypical squamous cells of undetermined significance (ASCUS), atypical glandular cells of underdetermined significance (AGUS), or found cytologically normal. Women referred to the colposcopy clinic but found to be negative for oncogenic HPV and normal upon histological diagnoses will be eligible as normal controls; this approach will be an ethical method for collecting biopsies from essentially "normal" women as there are many benign "look alike" conditions that are ruled out in colposcopy clinics. While this group may not be a random sample of the general population, the use of specimens from these women as controls will ensure a group of women who are truly confirmed as having no neoplasia.

You may not qualify if:

• Women attending the clinic solely for vaginal colposcopies will be excluded from the study. Women who are under 18 years of age or pregnant at the visit will also be excluded from the study. In addition, women who have had prior treatment (women coming to the clinic for a follow-up visit subsequent to treatment (women coming to the clinic for a follow-up visit subsequent to treatment or women coming for their initial clinic visit following pretreatment with chemotherapy or radiation) will be excluded. All women with known HIV or AIDS will be excluded from the study. This information will not be readily available unless the woman has previously been seen at the University of Oklahoma clinic. This event is considered rare; recent studies of HIV and AIDS by the University of Oklahoma from the same population have been terminated due to the lack of HIV/AIDS detected in the population.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Oklahoma

Oklahoma City, Oklahoma, United States

Location

Related Publications (5)

• Bustin SA. Absolute quantification of mRNA using real-time reverse transcription polymerase chain reaction assays. J Mol Endocrinol. 2000 Oct;25(2):169-93. doi: 10.1677/jme.0.0250169.

  PMID: 11013345 BACKGROUND

• Hildesheim A, Herrero R, Castle PE, Wacholder S, Bratti MC, Sherman ME, Lorincz AT, Burk RD, Morales J, Rodriguez AC, Helgesen K, Alfaro M, Hutchinson M, Balmaceda I, Greenberg M, Schiffman M. HPV co-factors related to the development of cervical cancer: results from a population-based study in Costa Rica. Br J Cancer. 2001 May 4;84(9):1219-26. doi: 10.1054/bjoc.2001.1779.

  PMID: 11336474 BACKGROUND

• Liaw KL, Glass AG, Manos MM, Greer CE, Scott DR, Sherman M, Burk RD, Kurman RJ, Wacholder S, Rush BB, Cadell DM, Lawler P, Tabor D, Schiffman M. Detection of human papillomavirus DNA in cytologically normal women and subsequent cervical squamous intraepithelial lesions. J Natl Cancer Inst. 1999 Jun 2;91(11):954-60. doi: 10.1093/jnci/91.11.954.

  PMID: 10359548 BACKGROUND

• Wentzensen N, Walker J, Smith K, Gold MA, Zuna R, Massad LS, Liu A, Silver MI, Dunn ST, Schiffman M. A prospective study of risk-based colposcopy demonstrates improved detection of cervical precancers. Am J Obstet Gynecol. 2018 Jun;218(6):604.e1-604.e8. doi: 10.1016/j.ajog.2018.02.009. Epub 2018 Feb 17.

  PMID: 29462629 DERIVED

• Liu AH, Walker J, Gage JC, Gold MA, Zuna R, Dunn ST, Schiffman M, Wentzensen N. Diagnosis of Cervical Precancers by Endocervical Curettage at Colposcopy of Women With Abnormal Cervical Cytology. Obstet Gynecol. 2017 Dec;130(6):1218-1225. doi: 10.1097/AOG.0000000000002330.

  PMID: 29112672 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Nicolas Wentzensen, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: September 12, 2003
• Primary Completion: April 15, 2015
• Study Completion: March 11, 2020
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

US (1)