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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