Adenocarcinoma of the Uterine Cervix and HPV

March 22, 2023 updated by: Luca Giannella, Università Politecnica delle Marche

In Situ/Microinvasive Adenocarcinoma of the Uterine Cervix and HPV-type Impact: Pathologic Features, Treatment Options, and Follow-up Outcomes - Cervical Adenocarcinoma Study Group (CAS-Group).

The present study will mainly aim to review and characterize the pathologic features, treatment options, and follow-up outcomes of women with in situ/microinvasive 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 11.2 per 100.000 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.

Study Type

Observational

Enrollment (Actual)

148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ancona, Italy, 60123
        • Department of Gynecology and Obsetrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All women who were diagnosed with in situ or microinvasive (stage 1 A) adenocarcinoma of the uterine cervix, and undergoing surgical treatment, between 2012 and 2016.

Description

Inclusion Criteria:

  • Women with in-situ or microinvasive (stage 1A) adenocarcinoma of the uterine cervix undergoing conization or hysterectomy, between January 2012 and December 2016.
  • Women with HPV testing within 2 months before conization.
  • Women should be diagnosed and managed by the corresponding center.
  • Patients with adequate clinical and pathological data.

Exclusion Criteria:

  • Women with previous cervical treatments.
  • Women with immunological disease (e.g. HIV).
  • Unavailable HPV testing before surgery.
  • Women with inadequate follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Positive high-risk HPV
Women with adenocarcinoma of the uterine cervix and positive for high-risk HPV (genotype16/18/31/33/35/39/45/51/52/56/58/59/68).
Procedure: Conization and/or Hysterectomy
Women undergoing cervical conization or simple/modified/radical hysterectomy with or without pelvic lymphadenectomy
Negative high-risk HPV
Women with adenocarcinoma of the uterine cervix and negative for high-risk HPV (genotype16/18/31/33/35/39/45/51/52/56/58/59/68).
Procedure: Conization and/or Hysterectomy
Women undergoing cervical conization or simple/modified/radical hysterectomy with or without pelvic lymphadenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall recurrence at 5 year in HPV positive vs HPV negative women
Time Frame: At 5 years
Number of women who have recurrence after treatment divided by total number of patients at onset
At 5 years
Overall survival at 5 year in HPV positive vs HPV negative women
Time Frame: At 5 years
Number of women who are alive after treatment divided by total number of patients at onset
At 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV-type disease recurrence at 5 years
Time Frame: At 5 years
HPV genotypes associated with disease recurrence
At 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Politecnica delle Marche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 20, 2023

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-HPV2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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