Ignite Creation Date:
2024-05-06 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05267834
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2022-02-14
Brief Title:
Adenocarcinoma of the Uterine Cervix and HPV
Sponsor:
Università Politecnica delle Marche
Organization:
Università Politecnica delle Marche
Study Overview
Official Title:
In SituMicroinvasive Adenocarcinoma of the Uterine Cervix and HPV-type Impact Pathologic Features Treatment Options and Follow-up Outcomes - Cervical Adenocarcinoma Study Group CAS-Group
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study will mainly aim to review and characterize the pathologic features treatment options and follow-up outcomes of women with in situmicroinvasive adenocarcinoma of the uterine cervix according to HPV status positive versus negative high-risk HPV It will evaluate the impact of HPV status on the recurrence and survival during a follow-up of five years The present study will be a multi-institutional study including several oncological Italian Centers Data will be retrospectively collected from January 2012 to December 2016 with a total follow-up of 5 years
Detailed Description:
The incidence of cervical cancer in developed countries declined considerably in the last few decades This has been possible for efficient screening programs to which HPV vaccines have been added over the past 15 years Despite this global reduction in cervical lesions the incidence of adenocarcinoma of the uterine cervix AC increases in invasive and in situ stages This increase mainly affects women aged 30-40 with an incidence of 112 per 100000 women On the contrary the squamous histological lesions revealed an increase in the incidence of in situ lesions and a concomitant reduction of invasive stages These data would seem to suggest a delay in the diagnosis of cervical glandular lesions a shorter interval of disease progression from the adenocarcinoma in situ AIS to infiltrating stages or a different process of carcinogenesis
Most glandular cervical lesions occur at an early stage The standard of treatment for in situ or micro-invasive lesions is extra fascial hysterectomy AIS or stage 1A1 with no LVSI or modified radical hysterectomy with pelvic lymph node dissection stage 1A1 with LVSI or 1A2 In fertility-sparing treatment conization or radical trachelectomy with pelvic lymph node dissection is an option
Another aspect that differentiates cervical adenocarcinoma from squamous lesions is the link with HPV infection In 2018 the International Endocervical Criteria and Classification categorized cervical glandular lesions into HPV-associated and non-HPV-associated AC Unlike cervical squamous lesions which are almost all linked to high-risk HPV types AC can be HPV negative in up to 15-20 of cases The HPV 18 genotype is the most represented in AC with a rate of 38-50 in AIS and 50 in invasive stages Based on some studies it appears that non-HPV-related lesions have worse outcomes This can significantly impact screening programs where 14 high-risk HPVs are tested
In a recent study including 341 surgical specimens of AC 100 of non-HPV-related lesions were classified as Silva Pattern C the worst prognostic pattern Instead no impact of the HPV genotype was found on 113 women with AC during a follow-up of 5 years HPV 45 showed a shorter 5-year survival than HPV 16 or 18
While for advanced lesions the stage itself represents the most important prognostic factor for prognosis in situ or micro-invasive lesions may represent the best target for evaluating HPV status impact This may be of interest as there is the option of conservative treatment in addition to standard treatment in early stages
Most glandular cervical lesions occur at an early stage The standard of treatment for in situ or micro-invasive lesions is extra fascial hysterectomy AIS or stage 1A1 with no LVSI or modified radical hysterectomy with pelvic lymph node dissection stage 1A1 with LVSI or 1A2 In fertility-sparing treatment conization or radical trachelectomy with pelvic lymph node dissection is an option
Another aspect that differentiates cervical adenocarcinoma from squamous lesions is the link with HPV infection In 2018 the International Endocervical Criteria and Classification categorized cervical glandular lesions into HPV-associated and non-HPV-associated AC Unlike cervical squamous lesions which are almost all linked to high-risk HPV types AC can be HPV negative in up to 15-20 of cases The HPV 18 genotype is the most represented in AC with a rate of 38-50 in AIS and 50 in invasive stages Based on some studies it appears that non-HPV-related lesions have worse outcomes This can significantly impact screening programs where 14 high-risk HPVs are tested
In a recent study including 341 surgical specimens of AC 100 of non-HPV-related lesions were classified as Silva Pattern C the worst prognostic pattern Instead no impact of the HPV genotype was found on 113 women with AC during a follow-up of 5 years HPV 45 showed a shorter 5-year survival than HPV 16 or 18
While for advanced lesions the stage itself represents the most important prognostic factor for prognosis in situ or micro-invasive lesions may represent the best target for evaluating HPV status impact This may be of interest as there is the option of conservative treatment in addition to standard treatment in early stages
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None