Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive Cervical Cancer

NCT00458562 | Completed

• 7 other identifiers: 6113R01CA111187P30CA015704UWCC-6113UWCC-04-4928-B01FHCRC-6113CDR0000482330
• Study Type: observational
• Target: 1,680
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Finding certain changes in genes may help doctors predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer and may help the study of cancer in the future. PURPOSE: This clinical trial is studying genes that may predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer.

Conditions

Cervical Cancer; Precancerous Condition

Keywords

cervical cancer; atypical squamous cells of undetermined significance; stage 0 cervical cancer; cervical intraepithelial neoplasia grade 1; cervical intraepithelial neoplasia grade 2; cervical intraepithelial neoplasia grade 3

Outcome Measures

Primary Outcomes (3)

• Identification of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical cancer

  Use molecular assays to identify a panel of hypermethylated genes that are predictive of CIN-3/ICC among women with and without HIV infection. We will rank genes by their ability to discriminate normal cervical tissue from CIN-3/ICC after stratifying by HIV infection.

  3 years

• Assessment of the risk of developing CIN3 in relationship to human papillomavirus (HPV) persistence, HIV, and the presence or acquisition of candidate hypermethylated genes

  Perform a nested case control study assessing the risk of developing CIN-3 in relationship to HPV persistence, HIV, and the presence or acquisition of the candidate hypermethylated genes.

  3 years

• Identification of HIV-related factors associated with the presence or acquisition of specific hypermethylated genes

  Identify HIV-related factors (CD4 counts, viral load, HAART) which might be associated with the presence or acquisition of specific hypermethylated genes.

  3 years

Study Arms (3)

HIV+, <CIN2

HIV positive women without CIN2-3 or worse

HIV-, no >=CIN3 biopsy, HR HPV+

HIV negative women without biopsy-proven CIN3 or worse, and with high risk HPV infection

HIV-, <=CIN1, HPV- at screening

HIV negative women who are \<= CIN1 and HPV negative at screening

Eligibility Criteria

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

Study Population

All study participants will be African women presenting to the clinical sites in Dakar, Senegal. Subjects will be representative of ethnic and racial groups living in Senegal.

You may qualify if:

• Underwent Pap smear, human papillomavirus (HPV) testing, and HIV testing AND meets any of the following criteria:
• Biopsy and colposcopy confirmed cervical intraepithelial neoplasia (CIN) or invasive cervical cancer (ICC), meeting any of the following criteria:
• CIN grade 2-3 or higher
• Repeated CIN1 (times 6)
• Abnormal Pap smear (atypical squamous cells of undetermined significance \[ASCUS\] or worse)
• HIV seropositive
• Negative cytology but positive for high-risk human papillomavirus (HPV)
• Negative cytology and negative HPV
• HIV negative (without biopsy-proven CIN 3 or worse) and high-risk HPV infection (types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 55, 56, 58, 59, 68, 82, 83, 73)
• \>= 18 years of age
• Intact cervix
• Not pregnant
• Able to provide informed consent

You may not qualify if:

• \< 18 years of age
• Pregnant at screening
• Cervix not intact
• not able to provide informed consent

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Centre Hospitalier Universite De Fann

Dakar, BP 5035, Senegal

Location

Hopital Aristide Le Dantec

Dakar, BP 5126, Senegal

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cervical brush in PreservCyt, cervical swab in STM, cervical swab in Roche media, whole blood, void urine, cervical tissue biopsy.

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Precancerous Conditions; Atypical Squamous Cells of the Cervix; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Nancy B. Kiviat, MD

  Harborview Injury Prevention and Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2007
• First Posted: April 11, 2007
• Study Start: January 1, 2006
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

SE (2)