Patient case: 56-year-old female with melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing

Summary: To evaluate the agreement between NAAT results for Chlamydia trachomatis and Neisseria gonorrhoeae infection obtained with self-obtained vaginal swabs (SOVS), collected in a non-clinical setting vs. NAAT results using SOVS collected in a clinical setting. This is a new use of this specimen type as SOVS are FDA cleared only for use in clinics. The NAAT (Gen-Probe APTIMA Combo 2® Assay (AC2)) result with the home-collected SOVS specimen will be compared to the result obtained with an SOVS collected in the clinic on multiple platforms (Direct Tube Sampling (DTS) / Panther / Tigris). The term "home-collected" is used to refer to any specimen that is not collected in a clinic, since there is no certainty that a specimen is collected "at home" or in a restroom in an office setting, etc. To compare the SOVS results to an FDA cleared predicate test with the collection of two clinician collected vaginal swabs.

Detailed description: All potential participants enrolled in this study will undergo the following procedures:
  -  Informed consent (written) to participate in this study along with review of the Participant Information Sheet and Experimental Subject's Bill of Rights (per site requirements)
  -  Assessment of eligibility by nurse/clinician
  -  Collection of two SOVS in clinic
  -  Collection of two clinician collected vaginal swabs in the clinic
  -  Assessment of clinical signs or symptoms
  -  Group 1 - participants will collect two SOVS before clinic visit and deliver specimens to study staff at the clinic visit.
  -  Group 2 - participants will repeat collection of two SOVS at home after clinic visit and mail the specimens directly to the laboratory.
  Clinical examinations will be conducted as appropriate to the reason for the visit/exam but the clinic procedures are not included as part of the protocol.
  The enrollment strategy is designed to recruit a total of 3500 women with an average of 42-60 women per month over a 12-month recruitment period (500-700 women per site over the recruitment period). Participants will be seen and recruited in clinics at the participating STI-CTG, and other site clinics. At each participating clinical center, recruitment personnel will follow a site specific process that is designed to help identify potential participants. Only one visit is required to complete the study procedures. The total time required for a participant to complete this study may vary but is expected to be 45 minutes total time over 1 or 2 days. Intervals of several days between collection of the two specimens are likely for some women.
  Clinic staff will approach women in the clinic or via phone and explain the object of the study and requirements of participation. The consenting process adopted by each site will be dependent on their IRB approval. Written consent will be obtained for all participants.
  Participants will be given a Participant Information Sheet to read and keep. [In addition, sites and clinics in California must utilize the "Experimental Subject's Bill of Rights" that explains their rights as a research subject per California law.] For Group 1, the discussions will be by phone and the Information Sheet and Experimental Subject's Bill of Rights will be included in the collection kit that is mailed to participants. Clinic staff will utilize a standard script including a form of Q&A to ensure that participants have a basic understanding of the SOVS procedures. Participants will be encouraged to call the clinic staff with any questions when they receive the home collection kit.
  After the participant provides informed consent, the nurse/clinician will assign a unique participant number (PN) and note the consenting procedure and appropriate eligibility information on a Case Report Form (CRF). The nurse/clinician will discuss basic demographic, medical history and concomitant medication information with each participant and record the information either on a study specific notes page, or a CRF. These will be maintained in the participant's research study record. This information will be used to assess eligibility. Participants in both study groups will be provided with swab collection kits along with a diagram showing how to collect the SOVS specimens. The participant will collect the swabs in a designated place in the clinic (often a rest room) at the beginning of the visit before any other specimens are collected. Next, the nurse/clinician will conduct the examination to manage the participant's healthcare. If the standard of care at the clinic is an SOVS processed using AC2, the participant will undergo an additional specimen collection as per the local clinic's standard of care for diagnosis and management of Ct/GC. Standard protocols for clinical management may differ by study site and will not be modified as a result of this study. Beyond the laboratory's AC2 Ct/GC NAAT clinical results, site standard protocols are not relevant to this study. Participants will not be notified regarding test results from the SOVS collected solely for this study. This will end the Study participation for Group 1.
  At the end of the clinic visit for Group 2 participants, the nurse/clinician will provide them with the HOLOGIC|Gen-Probe, Inc. provided home swab collection kits (the same as those mailed to participants in Group 1). The kits are identical to the kits used in the clinic with the addition of a mailing container and relevant mailing labels. Participants will be instructed to return home (or to another non-clinical private location) and collect two additional specimens:
  -  within 24 hours of the clinic visit
  -  prior to resuming sexual activity
  -  prior to taking any antibiotics that have been prescribed
  Group 2 participants will then mail the specimens to the laboratory in the mailer provided within 24 hours of collecting the sample. Participants will be given the same instructions for collecting the swabs regardless of whether it is in the clinic restroom or at home. Group 2 participants will receive a follow-up communication 48 hours after their clinic appointment.
  Participants in both groups will complete all other study procedures at the clinic during the initial visit. One questionnaire will be administered to the participants (the Home-collected SOVS CRF) and only the following clinical data will be collected as part of this study - participant's age, gender, race/ethnicity, clinical signs & symptoms, date of exam, date/time specimen collected/mailed/received, UADEs (if any), and AC2 results.
  All laboratory evaluations will use the APTIMA Combo 2® assay for detection of Ct/GC infection on the SOVS specimens collected "at home" and "in clinic" across 3 different platforms (DTS, Panther, and Tigris). One set of specimen collection tubes ("at home" and "in clinic") will be tested on DTS at each of 5 to 7 laboratories associated with the clinical sites. A matched set of specimen collection tubes will be shipped to 1 of 3 designated laboratory sites to be tested on Panther. Once the Panther testing is completed, the same set of tubes will be shipped to 1 of 3 different laboratory sites to be tested on Tigris. Results will be compared to assess agreement of the paired specimens tested within each platform (DTS / Panther / Tigris).
  The APTIMA Combo 2® Assay (HOLOGIC | Gen-Probe Inc., San Diego, CA) is a nucleic acid amplification test (NAAT) that utilizes target capture for the detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae in clinician-collected endocervical, vaginal (VS-C), and male urethral swab specimens, SOVS specimens (when obtained in the clinic), and female and male urine specimens. The assay is FDA cleared for use with specimens from symptomatic and asymptomatic individuals.

Eligibility: Inclusion Criteria:
  -  Asymptomatic and symptomatic females ages 16-75
  -  Subjects scheduled for visits or presenting at Family Planning, OB/Gyn, STD or other clinics requesting (or candidates for) routine screening for Ct/GC
  -  Willing to provide informed consent (written per site institutional review board approval)
  Exclusion Criteria:
  -  Inability to provide informed consent
  -  Inability or unwillingness to collect a specimen at home (and mail it)
  -  On antibiotic therapy within the last 30 days
  -  Clinical conditions, such as cervicitis or pelvic inflammatory disease that would indicate presumptive treatment
  -  Contact to person with Ct or GC in need of epidemiologic treatment

Relevance to patient case: not relevant