New Strategies to Assess Anal Cancer Risk In Women

CompletedOBSERVATIONAL
Enrollment

143

Participants

Timeline

Start Date

July 31, 2016

Primary Completion Date

February 27, 2017

Study Completion Date

February 27, 2017

Conditions
Human Immunodeficiency Virus (HIV)Human Papillomavirus (HPV)
Interventions
PROCEDURE

Perianal and Digital Anorectal Exam

The physician will inspect the outside of the anus and use a gloved finger to feel the anus for any masses.

PROCEDURE

Cervical Swabs

A speculum will be inserted into the vagina to visualize the cervix. The sample for research tests will be collected with one ThinPrep cytobroom inserted into the cervix. Collection will be same for the sample to be paced in the RNA storage solution for future biomarker studies.

PROCEDURE

Anal Swabs

The anal cytology specimen will be collected by inserting a saline moistened cotton-tipped swab into the anus, rotating it clock-wise for 20 seconds, and placed in SurePath. The first twenty participants will have anal cells collected in two different ways for validation/optimization: 1) saline moistened Dacron swab placed directly in ThinPrep medium and 2) Medscand Cytobrush Plus, a special brush, placed directly into ThinPrep medium. After validation/optimization is complete for up to 20 participants, the best collection method will be selected and will be used for all future enrolled participants.

PROCEDURE

High Resolution Anoscopy (HRA)

High Resolution Anoscopy is a procedure that allows for examination and evaluation of the anal canal. Using a small thin round tube called an anoscope, the anal canal is examined with a high resolution magnifying instrument called a colposcope. Application of a mild acidic liquid (acetic acid or diluted vinegar) or a brown iodine-based solution (Lugol's) onto the anal canal facilitates evaluation of abnormal tissue such as anal dysplasia. If abnormal staining is seen using acetic acid (dense white lesion) or Lugol's solution (bright yellow lesion) a biopsy of that area will be obtained.

Trial Locations (1)

30308

The Ponce Center, Atlanta

All Listed Sponsors
lead

Emory University

OTHER

NCT02873741 - New Strategies to Assess Anal Cancer Risk In Women | Biotech Hunter | Biotech Hunter