The Use of the LuViva Advanced Cervical Scan to Identify Women at High-Risk for Cervical Neoplasia
18 Years and older, Female
CC-03-01-2020 (primary)
NCI-2022-10314
Summary
This study is designed to demonstrate that a multimodal hyperspectral device (LuViva) is able
to segregate women with abnormal screening tests into Low and High risk groups for the
purpose of determining whether they require enhanced colposcopy and additional biopsies in
order to increase detection of CIN2+ cervical disease.
Objectives
This study is a matched pair design, single-arm study with the following two treatments:
current standard of care (SOC) and the LuViva study device. After undergoing the LuViva test,
all study subjects will first undergo the SOC (i.e., nominal) colposcopy, with the
colposcopist noting on the case report form (CRF), locations of lesions with colposcopy
impression of CIN1+. Then the colposcopist will employ enhanced colposcopy measures that
include the use on Lugol's solution and green/blue filters. The colposcopist will note on the
CRF any additional lesions that became evident as a result of these enhanced measures,
regardless of colposcopic impression. Biopsies of these lesions will be taken. Biopsies
identified using SOC practices will be placed in vials labeled "SOC Samples". Biopsies
identified using enhanced practices will be placed in vials labeled "Additional Samples". The
colposcopist will then take a biopsy from any quadrant at the squamocolumnar junction (SCJ)
in which a lesion was not observed. These biopsies will be placed in the vial labeled
"Additional Samples". Once all colposcopy procedures are completed, biopsies of lesions
collected, and biopsies of any non-lesion identified quadrants collected, an ECC, if
indicated, will be collected. If an ECC would have been taken per SOC practices, it will be
placed in a vial labeled "SOC ECC". ECCs collected per enhanced procedures will be placed in
a vial labeled "Additional ECC". The study is a matched pair design because all subjects are
tested with the LuViva device, and all will undergo both the nominal (minimal) colposcopy and
biopsy treatment pursuant to ASCCP Guidelines as well as enhanced colposcopy and biopsy. By
analyzing all biopsy specimens from SOC procedures and enhanced procedures, it can be
determined 1) Whether enhanced procedures can be justified when the LuViva test indicates
High-risk by the increase in detection of CIN2+ and 2) That when LuViva indicates Low-risk,
that enhanced procedures (in the absence of a LuViva High-risk result) are not the reason for
increased detection of CIN2+. Subjects will be enrolled during their normally scheduled
colposcopy visit and will be recruited from the pool of patients that are referred to
colposcopy based on the ASCCP Guidelines published in April 2020. The total number of
enrolled female subjects pooled across all clinical sites combined will not exceed 500 in
order to target an evaluable cohort of approximately 400 women.
Eligibility
- Able to read or understand and give informed consent
- Referral Pap test within 120 days
- Scheduled for colposcopy based on the 2019 ASCCP Management Guidelines that fall within the 4% to 59% Immediate CIN3+ risk with the exception of women who lack a cervix or may be pregnant and are recommended to colposcopy.*
- Notes: The rationale for defining the referral inclusion criteria as women scheduled for colposcopy is that this group has been identified with having a significant likelihood of being diagnosed with CIN2+ over the two year period after being referred to colposcopy because of an abnormal screening test or tests. For example, the ALTS results showed that women with ASC-US plus high-risk HPV, LSIL, ASC-H, AGC and HSIL all had a likelihood of CIN2+ of approximately 10% to 20% or greater in the cases of ASC-H and HSIL (5). More recently, it has been shown that this threshold also carries with it a 4% or greater likelihood of immediate CIN3+ (12).
Treatment Sites in Georgia
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